CONSENT FOR THIRD MOLAR TOOTH EXTRACTIONS...Emma Badenoch-Jones MBBS, BDSc Submitted in fulfilment...

CONSENT FOR THIRD MOLAR TOOTH EXTRACTIONS

Emma Badenoch-Jones MBBS, BDSc

Submitted in fulfilment of the requirements for the degree of Master of Applied

Science (Research) (HL84)

Faculty of Health

Queensland University of Technology

2018

CONSENT FOR THIRD MOLAR TOOTH EXTRACTIONS i

Keywords

Law, litigation, negligence, complication, risk, consent, extraction, removal, third molar, oral and maxillofacial surgery, oral surgery.

CONSENT FOR THIRD MOLAR TOOTH EXTRACTIONS ii

Abstract

Background/Aims: There are persistent concerns about litigation in the dental and

medical professions. These concerns arise in a setting where general dentists are more

frequently undertaking a wider range of oral surgery procedures, potentially

increasing legal risk. There are currently no evidence-based consent forms for oral

surgery procedures in Australia/New Zealand. We aimed to develop an evidence-

based consent form for third molar tooth extractions, as there is currently none. We

conducted three studies towards this aim. The consent form does not propose to

dictate what the legal standard should be for risk disclosure, or to eliminate liability

for the risks cited, but rather it aims to guide appropriate information provision.

Methods:

(1) An online survey was distributed to 180 consultant oral and maxillofacial surgeons

in Australia and New Zealand to determine their practice for obtaining informed

consent for third molar tooth extractions. Surgeons were asked to answer (yes/no)

whether they routinely warned of a specific risk with third molar tooth extractions in

their written consent.

(2) Judicial cases dealing with medical negligence in the fields of general dentistry

(oral surgery procedure) and oral and maxillofacial surgery were located using the

three main legal databases. Relevant cases were analysed to determine the procedures

involved, the patients’ claims of injury, findings of negligence and damages awarded.

A thematic analysis of the cases was undertaken to determine trends. The findings of

Arm 2 were used to dictate

(3) A survey was designed to determine the risks of third molar tooth extraction that

participants would want to be warned of if undergoing the procedure. It was

distributed to 218 university students. Participants were given an explanation of a risk

and information on its incidence, and asked (yes/no/not understood) whether they

would want to be warned of it.

The information gathered in Arms 2 and 3 were used to dictate the information

included on the consent form. Arm 2 indicates what the court considers to be

important information. Arm 3 is a source of information on what participants consider

CONSENT FOR THIRD MOLAR TOOTH EXTRACTIONS iii

to be important and may be one source of information that the courts consider in

making their deliberations.

Results

(1) Seventy-one replies were received (39%) from the online survey. Surgeons most

frequently disclosed the risk of nerve injuries in their written consent. Ranked

according to the proportion of surgeons who warned of the risk in their written

consent, temporary and permanent inferior alveolar nerve injuries were ranked equal

first out of 30 risks, while temporary and permanent lingual nerve injuries ranked

third and fourth, respectively. A general warning of infection (not alveolar osteitis)

was ranked fifth.

(2) Fifteen cases over a 20-year period were located across all Australian

jurisdictions except the Northern Territory by our search on the legal databases (eight

cases involved general dentists; seven cases involved oral and maxillofacial

surgeons). Eleven of the 15 cases involved determinations of whether or not the

practitioner had failed in their duty of care; negligence was found in six cases. Eleven

of the 15 cases related to molar extractions (eight specifically to third molar).

(3) We collected 218 responses from university participants. Ranked according to the

proportion of participants who wanted a warning of the risk, dry socket, infection, and

excessive bleeding were ranked 1, 2, and 3, respectively, out of 22 risks. Temporary

damage to the inferior alveolar and lingual nerves were ranked 4 and 6 out of 22 risks,

respectively. Permanent nerve damage to the inferior alveolar and lingual nerves were

ranked 10 and 12 out of 22 risks, respectively.

Conclusions:

There was no universal agreement among Australian and New Zealand oral and

maxillofacial surgeons regarding risk disclosure for third molar tooth extractions.

Arm 1 highlighted the need for a more consistent approach to risk disclosure for third

molar tooth extractions among surgeons.

There was less variation in the proportion of participants who wanted to be

warned of different risks compared with the variation in the proportion of surgeons

who disclosed those risks (range of 48% to 91% for the proportion of participants who

wanted to be warned of different risks; range of 7% to 97% for surgeons’ warnings of

CONSENT FOR THIRD MOLAR TOOTH EXTRACTIONS iv

those risks.

Participants most frequently wanted a warning of conditions which impede

healing or recovery from the procedure in the early post-operative period, whereas

surgeons most frequently warned of the risk of temporary and permanent nerve

damage. While participants wanted a warning of the risk of temporary nerve damage

relatively frequently, they wanted a warning that the nerve damage could be

permanent less frequently.

According to judicial cases, in deciding on risk disclosure, a practitioner

should consider the incidence of the risk and how necessary the treatment is. They

should disclose material risks (particularly nerve damage, infection, and the possibly

of neuropathic pain for third molar extractions), and in the general dental setting,

should discuss the relative risks of accepting or declining a referral to a specialist for

treatment.

CONSENT FOR THIRD MOLAR TOOTH EXTRACTIONS v

Table of Contents

Keywords ............................................................................................................................. iAbstract ............................................................................................................................... iiList of Tables ..................................................................................................................... viList of Abbreviations ......................................................................................................... viiAcknowledgements ............................................................................................................ ixChapter 1: Introduction ................................................................................... 11.1 Background ................................................................................................................ 11.2 Context....................................................................................................................... 1 1.3 Purposes ..................................................................................................................... 21.4 Significance, Scope and Definitions ............................................................................ 41.5 Thesis Outline ............................................................................................................ 6Chapter 2: Literature Review .......................................................................... 72.1 Overview - Third molar teeth, their removal, and risks of removal .............................. 72.2 Consent and the law.................................................................................................. 122.3 Third molar surgery - information provision in australia/new zealand ....................... 152.4 Summary and Implications ....................................................................................... 15Chapter 3: Research Design............................................................................173.1 Methodology and Research Design ........................................................................... 173.2 Participants ............................................................................................................... 223.3 Instruments ............................................................................................................... 233.4 Procedure and Timeline ............................................................................................ 263.5 Analysis ................................................................................................................... 293.6 Ethics and Limitations .............................................................................................. 30

Chapter 4: Results ...........................................................................................35Chapter 5: Analysis .........................................................................................47Chapter 6: Conclusions ...................................................................................57Bibliography ..........................................................................................................61Appendices ............................................................................................................65Appendix 1 ........................................................................................................................ 65Appendix 2 ........................................................................................................................ 66

CONSENT FOR THIRD MOLAR TOOTH EXTRACTIONS vi

List of Tables

Table 1. Guidelines on the indications for third molar tooth removal

Table 2. Published incidences for risks of third molar tooth extraction

Table 3. Vascular, infective and neurological complications of third molar tooth

extractions. Number (%) of respondents who routinely included or did not include the

risk in their written consent, and total number of responders

Table 4. Technical complications of third molar tooth extractions. Number (%) of

respondents who routinely included or did not include the risk in their written consent,

and total number of responders

Table 5. Complications of third molar tooth extractions related to adjacent structures.

Number (%) of respondents who routinely included or did not include the risk in their

written consent, and total number of responders

Table 6. General Agreement among surgeons that risk disclosure was required (≥80%

routinely included that risk in their written consent) or that risk disclosure was not

required (≥80% did not routinely include that risk)

Table 7. Australian medical negligence cases in the field of oral and maxillofacial

surgery and general dentistry (oral surgery procedures)

Table 8. Number (%) of respondents who wanted to be warned of the particular risk

with third molar tooth extractions prior to deciding whether to have the procedure

Table 9. Elements of the third molar consent form and evidence base for each element

CONSENT FOR THIRD MOLAR TOOTH EXTRACTIONS vii

List of Abbreviations

NICE: National Institute for Health and Care Excellence

AAOMS: American Association of Oral and Maxillofacial Surgery

ANZAOMS: Australian and New Zealand Association of Oral and Maxillofacial

Surgery

QUT: Queensland University of Technology

CONSENT FOR THIRD MOLAR TOOTH EXTRACTIONS viii

Statement of Original Authorship The work contained in this thesis has not been previously submitted to meet

requirements for an award at this or any other higher education institution. To the best

of my knowledge and belief, the thesis contains no material previously published or

written by another person except where due reference is made.

Signature: QUT Verified Signature

Date: November 2018

CONSENT FOR THIRD MOLAR TOOTH EXTRACTIONS ix

Acknowledgements

1) Professor Benjamin White for his contribution to drafting the plan for the project,

for his thorough review/edit of the analysis of litigation cases (Arm 2) prior to journal

publication (Professor Benjamin White was a co-author on the resulting publication),

for providing medicolegal expertise in drafting the patient survey (Arm 3), and for his

provision of legal advice on general queries related to the project/drafting of the

consent form.

2) ANZAOMS for distributing our online survey to consultant members of their

association.

Chapter 1: Introduction 1

Chapter 1: Introduction

1.1 BACKGROUND

Written consent for invasive procedures is standard practice in all Australian hospitals

and in many private healthcare settings. During our work in the medical and dental

fields, my supervisor Associate Professor Anthony Lynham as an oral and

maxillofacial surgeon, and myself as a general dentist and junior medical officer, have

used a number of medical consent forms, and have found them not to be evidence-

based, but rather based on a general knowledge of the subject area.

Our preliminary literature review on the topic of consent for medical procedures

revealed a paucity of available evidence. We hypothesized that consent forms are not

evidence-based due to the lack of quality evidence upon which to devise a form.

We sought medicolegal expertise from Professor Benjamin White (lawyer, Faculty of

Law QUT, and Director of Australian Centre for Health Law Research) who

specializes in health law and who agreed that there was limited available evidence to

guide practitioners in the consent process. There is also only a small body of work

examining the Australian law and dental practice.1, 2 Given our area of medical

interest/practice, our idea was to conduct studies to provide evidence to guide consent

processes specifically for third molar tooth extractions, and to subsequently develop

an evidence-based consent form for the procedure using the evidence gathered.

1.2 CONTEXT

Our focus for the project was third molar tooth extractions. This is a procedure

performed by both general dentists and by oral and maxillofacial surgeons (as discussed

in Section 2.1). It is the most commonly performed procedure by oral and maxillofacial

surgeons.

My particular interest in this field is due to my desire to pursue oral and

maxillofacial surgery training, a specialty requiring acquisition of a dental and a

medical degree, followed by formal specialty training. At the time of starting the project


I was a general dentist completing a medical degree, and by completion, I had obtained

my medical qualification and was working as a general dentist and as a junior medical

officer.

The broader trends in healthcare provision in Australia are important to our topic.

General dentists in Australia are carrying out an increasing number of ‘oral surgery’

procedures that are challenging and require expertise. In particular, they are carrying

out an increasing number of third molar tooth extractions (often the most challenging

of all tooth extractions). Australian university dental degrees generally provide

insufficient training for these procedures. For difficult tooth extractions (including third

molars), general dentists can augment their skills over time. Many post-graduate

training courses do not offer the opportunity to perform treatment on patients, and as

such, many dentists perform challenging surgical cases on private patients rather than

in a training institution.

It is likely that the trend of general dentists performing a greater number of

difficult oral surgery procedures is due, in part, to current market forces, with an

increased supply of general dentists in Australia in recent years and saturation of the

market, particularly in city areas.3 In the current climate, general dentists may be more

willing to take on complex procedures with which they have less experience.

We propose that this may the increase legal risk to practitioners. It also occurs at

a time when there are increased concerns about litigation in the dental and medical

professions. Therefore the use of evidence-based consent processes is likely to be more

important today than it was in the past.

As outlined below, there is little published data on trends in legal claims relating

to different areas of general dentistry. The vast majority of disputes settle without the

need for judicial resolution and insurance companies make available limited data. A

small number of cases require judicial resolution and are publicly available.

1.3 PURPOSES

As outlined above, the research problem to be addressed was the current lack of

objective evidence-based information available to practitioners to guide them in the

consent process for third molar tooth extractions.


We sought to derive this evidence from three separate arms of our project:

1st arm:

Aims:

1. To examine the current practice for obtaining informed consent for third molar tooth

extractions by oral and maxillofacial surgeons in Australia and New Zealand by

conducting a survey of practitioners.

2. As part of the above aim, to determine the risks of third molar tooth extractions that

practitioners include in their written consent.

2nd arm:

Aims:

1. To locate judicial cases dealing with medical negligence in the fields of general

dentistry (oral surgery procedures) and oral and maxillofacial surgery.

2. To analyse relevant cases to determine the procedures involved, the patients’ claims

of injury, findings of negligence and damages awarded.

3. To perform a thematic analysis of the cases to determine trends.

4. To make recommendations to practitioners on strategies to minimize their legal risk

based on the trends.

3rd arm:

1. To determine the risks of third molar tooth extraction that patients want to be warned

of when undergoing the procedure (patient preferences in risk disclosure).

Practical outcomes:

We aimed to consolidate the information obtained from the three arms of our study to

develop an evidence-based consent form for third molar tooth extractions. It is the hope

of this research team that the consent form will be a gold standard for national use,

providing more consistency in consent for third molar tooth extractions in Australia and

New Zealand.


We plan to discuss distribution of our consent form with the ANZAOMS. As noted

below, they currently have ownership of a pamphlet that is widely distributed to

private oral and maxillofacial surgeons. It may be feasible for the ANZAOMS to

adopt our consent form (or a variation of it) for distribution through their association,

although we have not yet approached them with this suggestion.

1.4 SIGNIFICANCE, SCOPE AND DEFINITIONS

Significance

We discussed above the persistent concerns about litigation in the dental and medical

professions, and the current lack of evidence upon which to base consent processes.

Improving the consent process has benefits for both the patient and the practitioner.

For the practitioner, there are benefits to appropriate disclosure of information

about the proposed procedure, including its risks. One of the obvious roles of the

evidence-based consent form is in providing a degree of legal protection, should

complications of the procedure arise. However, information provision also educates

the patient, and is a means of building rapport with the patient and eliciting their

cooperation with the proposed treatment. It is therefore improves the medical service.

This will be expounded on below, as for example, disclosure of risks needs to be

weighed against discouraging a patient from undergoing a procedure that is in their

best interests.

For the patient, appropriate information provision empowers them to make an

informed choice regarding their treatment and may lead to improved satisfaction with

treatment outcomes.

Scope

We limited our project to a consideration only of third molar tooth extractions

because it is a common procedure for general dentist and oral and maxillofacial

surgeons. During the course of our research, we examined medicolegal considerations


for other oral surgery/oral and maxillofacial surgery procedures because it contributed

to our accumulation of evidence to guide consent for third molar extractions. There

were other outcomes of this research that are expounded on below. A separate

examination of consent for other oral surgery/oral and maxillofacial surgery procedures

could be performed at a later date.

There is no clear delineation between a sequelae/side effect (or expected

outcome) of a procedure, and a risk/complication (or unexpected outcome) of a

procedure. For the purpose of this project, pain, minor bleeding, bruising, trismus and

swelling were considered expected outcomes, and were not considered risks or

complications of the procedure. Similarly the risks of sedation or a general anaesthetic,

if performed for tooth extraction, were not considered in this study.

Given that legal systems and legislature are different in different countries, our

project is intended to be relevant to practitioners in Australia and New Zealand. The

legal systems of Australia and New Zealand are similar. Our project may not be relevant

to practitioners in other countries

Legal Terminology/Definitions

Causation (legal): ‘the defendant’s act must be an operative and substantial cause of

the consequence’4

Consent: ‘at law, agreement to expose oneself to a risk or participate in an activity, or

more generally, an acceptance of a certain outcome’4

Judicial power: ‘broadly, the independent power granted to the courts by Constitution

Ch III; the judicial power of the Commonwealth’4

Professional negligence: ‘at common law a legal practitioner has a duty to provide

professional services with a fair, reasonable and competent degree of care and skill’4

Trespass (to the person): ‘interference with, or injury to, the body of another person

without the person's permission’4


1.5 THESIS OUTLINE

This thesis has six chapters. Firstly, we review the literature; this includes a discussion

of contemporary Australian law concerning consent for medical procedures, and a

discussion of the literature pertaining to management of third molar teeth, including

indications for their removal. We then detail our research methodology, and results, and

present our analysis and conclusions, including our evidence-based consent form for

third molar tooth extractions.

Chapter 2: Literature Review 7

Chapter 2: Literature Review

2.1 OVERVIEW - THIRD MOLAR TEETH, THEIR REMOVAL AND RISKS OF REMOVAL

Third Molar Teeth and Their Management

As stated above, third molar extractions are commonly performed in both the

general dental setting and by oral and maxillofacial surgeons. General dentists may

refer the procedure to their specialist colleagues for a number of reasons. These include

concerns regarding the technical difficulty of the procedure (which varies according to

the particular case and is influenced by operator experience), selective practice (i.e.

practitioner choice not to perform certain procedures for a number of reasons, such as

personal or clientele preference for specialist management), reduction of risk to the

patient when the procedure is performed by a specialist, minimisation of legal risk to

the practitioner who does not wish to expose themself to potential complications of the

procedure, and patient preference for treatment under sedation or general anaesthesia

(when the general dentist does not offer this).

The indications for removal of third molar teeth, and the timing of their removal,

has long been a source of debate and research. Ultimately, teeth are removed either

prophylactically, due to the potential for pathology, or they are monitored and removed

at some point after they are affected by pathology.5 Pathology includes caries, pulpal

or periapical pathology, pericoronitis, abscess formation/cellulitis and osteomyelitis,

internal/external resorption of the tooth or adjacent teeth, fracture of the tooth, disease

of the follicle including a cyst or tumour, a tooth or teeth impeding surgery including

reconstructive jaw surgery, and when a tooth is involved within the field of tumour

resection.5 As a consequence of their position in the jaw, third molar teeth are more

prone to pathology than other teeth.5 There are also other, less commonly utilized ways

of managing third molar teeth as an alternative to their removal. These include surgical

tooth exposure, coronectomy, tooth repositioning, transplantation, surgical

periodontics, and marsupialization of associated soft tissue pathology.5


The debate surrounding the timing of the removal of third molars is influenced

in large part by the difficulty in predicting which teeth will be affected by pathology,

and when. On the one hand, there is the potential for harm to patients from the

development of pathology if third molars are retained. On the other hand, there are

risks associated with the removal of a tooth that may not be affected by pathology if

retained. This balance of facts is also influenced by the knowledge that surgery in

younger patients has a lower risk of complications and significantly lower associated

morbidity than surgery in older patients. For teeth that are retained, there has

specifically been uncertainty surrounding the degree to which pericoronitis episodes

should dictate a decision for tooth removal. Ultimately, the patient, in consultation

with their treating practitioner, must weigh up the risks and benefits of the procedure

with the risks of not proceeding, to make an informed decision on treatment.

There are also public health forces that influence treatment provision, most

notably the nature of funding in the particular healthcare system i.e. the degree of

public versus private funding.

There are two internationally recognised guidelines that provide position

statements on the indications for removal of third molar teeth based on available

evidence: the NICE guidelines ‘Guidance on the Extraction of Wisdom Teeth’5

(British), which were published in 2000, and the AAOMS advocacy and position

paper (white paper) ‘Management of Third Molar Teeth’6 (American), which was

published in 2016. These guidelines undergo regular updating. Minor changes to the

NICE guidelines were made in 2012 and 2014, and further updates are in progress,

with a newer version due to be published soon.

Table 1. Guidelines on the indications for third molar tooth removal

Country of origin Recommendations

NICE Guidelines

(2000)5

United Kingdom (UK)

Endorsed by: not stated

Third molar teeth should only be removed if there is

evidence of pathology.

A single pericoronitis episode is not an indication

for removal, unless it is particularly severe. Removal

in the case of any recurrent episodes (i.e. two or

more episodes) is recommended.


AAOMS guidelines

(2016)6

United States of America (US)

Endorsed by:

-American Academy of Oral and

Maxillofacial Pathology

-American Academy of Oral and

Maxillofacial Radiology

-American Academy of Pediatric Dentistry

-American Academy of Endodontists

-American Association of Orthodontists

-American College of Oral and Maxillofacial

Surgery

-British Association of Oral and Maxillofacial

Surgery

-British Association of Oral Surgeons

-Canadian Association of Oral and

Maxillofacial Surgeons

-International Association of Oral and

Maxillofacial Surgeons

A decision to retain third molars vs prophylactically

remove should be made by the middle of the

patient’s third decade.

Third molar teeth that are associated with disease, or

are at high risk of developing disease, should be

surgically managed. In the absence of the former,

clinical and radiographic surveillance is indicated.

Regarding disease-free teeth, clinicians should

utilize their expertise in recognizing the likelihood

that pathology will develop.

Removal should be favoured when the third molar is

currently or likely to be non-functional, there is an

overlying prosthesis, orthodontic removal is

justified, and in the case of planned orthognathic

surgery.

There is an obvious discrepancy between the positions of the NICE and AAOMS. The

AAOMS is clearly more supportive of early intervention. It is likely that this is

influenced in large part by the nature of health care funding in the UK versus the US.

The health care system in the UK is primarily publicly funded (through the National

Health System), while the health care system in the US is primarily privately funded,

though premiums paid to private health insurance companies.

Incidence of Risks


There is a significant body of literature devoted to expounding the risks of third molar

tooth extraction. However, there is a lack of quality reviews regarding the statistical

risk of complications. The three main reviews on the topic are those by Bouloux GF et

al,7 Marciani RD,8 and Susarla SM et al.9 None of them undertook systematic

literature searches, which is the appropriate standard for such reports.

The reviews report very large incidence ranges and there are obvious

inconsistencies between them (see Table 2). As such, during risk disclosure,

information provided to patients on the incidence of risks is likely to vary between

practitioners, and may on occasion be inaccurate. As outlined below (Chapter 5),

there is little legal basis for discussing the statistical risk of complications with

patients, however accurate information would help to guide clinicians in the consent

process, and is nevertheless useful information for patients.

Table 2. Published incidences for risks of third molar tooth extraction

Incidence reported

Risk/Complication Bouloux et al7 Marciani RD8 Susarla SM et al9

Clinically significant

bleeding/hemorrhage

0.2-5.8% NR 1-6%

Alveolar osteitis 0.3-26% NR 1-30%

Infection, not alveolar osteitis 0.8-4.2% NR 3-5%

Deep fascial space infection NR NR ‘Low’

Paraesthesia/anaesthesia - inferior

alveolar nerve (lower lip)

NR Temporary: 3.9%

Permanent: 0.04%

Temporary: 0.5-5%

Permanent: ‘considerably less

than 1%’

Paraesthesia/anaesthesia - lingual

nerve (tongue)

NR Temporary: 1-2.6%

Permanent: NR

Temporary: 0.02-0.06

Permanent: spontaneous

recovery ‘less common’ than

inferior alveolar nerve injury

Paraesthesia/anaesthesia - nerves

other than inferior

NR NR NR


alveolar/lingual nerves (including

buccal nerve, mylohyoid nerve)

Damage to adjacent tooth/teeth 0.3-0.4% NR NR

Bone fracture - Fracture of the

alveolus

NR NR NR

Bone fracture - Maxillary

tuberosity fracture

0.6% NR NR

Bone fracture - Mandibular jaw

fracture

0.0049%

NR 0.00049%

Displacement of teeth or roots NR NR NR

Incomplete tooth/root removal NR NR NR

Wound dehiscence NR NR NR

Periodontal defects NR NR NR

Soft tissue injury NR NR NR

Bony sequestra NR NR NR

Oroantral communication/fistula 0.008-0.25 NR NR

Oronasal communication/fistula NR NR NR

Temporomandibular joint

complications

NR NR NR

Aspiration or ingestion (including

of tooth, tooth fragment, other

material or instrument)

NR NR NR

Subcutaneous and/or tissue space

empysema

NR NR NR

NR = not reported

Some of the complications listed in the table are clearly non-accidental, i.e. they

occur as a result of oral anatomy and healing processes (e.g. infection). Others clearly

occur as a result of an accident on the part of the operator (e.g. lip laceration, damage

to nearby tooth/teeth). While this distinction is clear for some complications, for

others it is less so. For these complications, patient anatomy and individual

predisposition to the complication, and the operator skills interact to determine risk.


How the courts deliberate on cases involving complications of third molar tooth

removal is expounded on below.

2.2 CONSENT AND THE LAW

Informed consent is the legal requirement to educate a patient about a proposed

medical treatment or procedure so that he or she can make informed decisions.17

Consent must be given voluntarily by a competent patient who is adequately informed

about the proposed treatment.17 For a patient to be competent, they must be able to

understand the information provided to them and be able to communicate their choice.

Consent may be given in writing, verbally, or by implication.17 While in-principle

consent should be given to a specific doctor, the nature of the Australian public health

system is such that this is often not guaranteed.

The National Health and Medical Research Council has published general

guidelines for medical practitioners regarding what information they should provide

to patients during the informed consent process.10 It includes the nature of the

proposed treatment, the risks and benefits, alternative treatment options, the

consequences of not proceeding, and the person who will undertake the procedure.

Risks to be disclosed include known risks that are common though slight, and rare

though severe, as well as particular risks material to the patient.10 Recognition and recall of information provided during the consent process has

been shown to be poor for third molar tooth extractions and other medical

procedures.11-14 Recognition and recall of information is improved for patients

undergoing third molar tooth extractions if written pre-operative information is

provided in addition to traditional verbal warnings.15 In a study by Layton S et al, it

did not matter if this information was given on admission, or one week prior to

admission.15 Studies for other medical procedures, however, show decreased recall

and recognition of pre-operative information with time.16

An Overview of the Law

All medical and dental practitioners must have a thorough understanding of

contemporary Australian law concerning consent. Each practitioner has a duty of care

to his or her patient that is outlined in the law.


Valid consent requires that the patient understands the proposed procedure in

broad terms only and is relevant to actions framed in trespass.17

On the other hand, negligence claims can arise in relation to issues such as

warning of risks, investigation (including failure to diagnose), treatment/procedure,

post-operative complications and patient follow-up.17 For a practitioner to be found

negligent, it must be established that he or she breached the duty of care and that the

breach caused the damage suffered (i.e. legal causation).1, 17

The standard of care imposed by the law of negligence has traditionally come

from the British common law. In common law, decisions are based on principles of

previous legal cases. More recently, however, each state/territory has enacted its own

legislation concerning medical negligence. These are collectively referred to as the

Liability Acts: Civil Law (Wrongs) Act 2002 (ACT); Civil Liability Act 2002 (NSW);

Personal Injuries (Liabilities and Damages) Act (NT); Civil Liability Act 2003

(QLD); Civil Liability Act 1936 (SA); Civil Liability Act 2002 (Tas); Wrongs Act 1958

(Vic); and Civil Liability Act 2002 (WA). Case law still plays a part in Australian law

even though there are now statutes in the form of Liability Acts; the cases inform how

the judges interpret the legislation.17

According to British common law, the test for determining whether a doctor is

negligent in any aspect of his work, including risk disclosure, is the Bolam principle

based on the case of Bolam v Friern Hospital.18 The practice of the doctor is not

negligent if it is widely accepted as competent by a ‘responsible body of relevant

professional opinion’.18 The Bolam principle was reinforced in Britain in the case of

Sidaway v Royal Bethlem Hospital.19 Later it was established that the court could

overrule peer professional opinion if it considered that the opinion was not logical

(Bolitho v City and Hackney Health Authority).20 This principle is known as the

modified Bolam principle. Britain has not had legislative developments like the

Liability Acts and remains guided by case law.

The Liability Acts in most Australian states/territories are consistent with the

modified Bolam principle, except with regards to risk disclosure.17 As per Bolitho v

City and Hackney Health Authority, courts in Australia can overrule peer professional

opinion if they consider that opinion irrational or contrary to written law, although the

wording varies according to the particular Australian jurisdiction.20

For risk disclosure, the standard is higher in Australia compared to Britain due

to legal development from the Australian High Court in the case of Rogers v


Whitaker.21 According to Rogers v Whitaker, a patient must be warned of all ‘material

risks’. A risk is considered a material risk

• if ‘a reasonable person in the patient’s position, if warned of the risk, would be likely

to attach significance to it’ (objective limb); or

• if ‘the medical practitioner is or should reasonably be aware that the particular patient,

if warned of the risk, would be likely to attach significance to it’ in light of their own

values and interests (subjective limb).21

Only some jurisdictions’ Liability Acts deal with the issue of risk disclosure, but

those that do, appear to have maintained a similar position to Rogers v Whitaker,

although some commentators consider that their wording is slightly more lenient.

There is some indication that UK case law is moving toward the Australian standards.

Rather than incidence alone prescribing what information should be provided, Chester

v Afshar in the UK indicated that risk disclosure should take into consideration the

particular patient’s circumstances.22

As per the legal principle of ‘causation’ outlined above, for damages to be

awarded the patient must prove that if they had known about the risk they would not

have undergone the procedure and the injury would not have occurred. The obligation

to warn patients of a material risk has also been suggested to be higher for non-

therapeutic procedures.23

It nevertheless remains difficult for clinicians to determine how much

information should be provided to an individual patient to achieve adequate risk

disclosure, i.e. to satisfy the legal standards. Unfortunately, what constitutes reasonable

risk disclosure can only be judged retrospectively in cases of litigation.

The Law In Different Countries

Australian and New Zealand law are similar, however the laws vary to a degree due to

the wording of legislature. Furthermore, case law in Australia is not binding in New

Zealand and visa versa. Other countries across the world have different and varying

legal systems.

Consent Forms

Cavell R24 published a paper that discusses medicolegal considerations in drafting a


medical consent form. It focuses on legal principles (eg, legal competency) and how

these should be addressed in the consent form (see Table 9). It is also intended as a

guideline for persons drafting a medical consent form. In broad terms, the point of

legal competency depends according to the jurisdiction. A detailed discussion of

medicolegal principle, including legal competency, is beyond the scope of this thesis.

2.3 THIRD MOLAR SURGERY - INFORMATION PROVISION IN AUSTRALIA/NEW ZEALAND

Practitioners in Australia and New Zealand use a variety of written consent forms.

Each state public health system has its own consent form for third molar extractions,

while private dentists and surgeons use a variety of written consent forms. Many of

the forms used by private practitioners are devised in-house.

The ANZAOMS wisdom tooth brochure, ‘Wisdom Teeth and What To Do

About Them’25 is widely used by Australian and New Zealand Oral and Maxillofacial

surgeons, although the exact percentage of practitioners who use it is not known. It

provides general information about wisdom teeth, indications for their removal, and

the extraction procedure. It outlines some of the potential complications of third molar

extraction. Those cited in the brochure are: lingual and inferior alveolar nerve damage

(temporary or permanent), post-operative neuropathic pain, alveolar osteitis, infection

- not alveolar osteitis (general warning), excessive bleeding (general warning),

unexpected soft tissue injury (lip sores), oro-antral communication, and bone fracture

(general warning).25

2.4 SUMMARY AND IMPLICATIONS

In the above Sections we outlined the legal principles that dictate decision making

regarding consent for medical procedures. In summary, aside from the governance of

legal principles, there is a paucity of available evidence on which to base consent for

third molar tooth extractions. In particular, there are no evidence-based consent forms

for the procedure. This leads to increased legal risks for practitioners. The

development of an evidence-based consent form for the procedure may ameliorate

these risks.

Chapter 3: Research Design 17

Chapter 3: Research Design

This chapter discusses our study protocols which were implemented to address our

research aims stated in Section 1.3. The protocol we used for each arm of our project

is discussed separately.

Section 3.1 outlines the methodology, including the specific type of study that was

performed in each arm of the project. Section 3.2 outlines the characteristics of the

participants for each arm of the project, and our rationale for choosing them. Section

3.3 discusses the research instruments that were necessary for carrying out each arm of

the project, and how they were developed. Section 3.4 outlines how our study method

was implemented, including how data were collected and recorded. Section 3.6

discusses how the data was analysed (quantitative vs qualitative) for each arm of our

project. In Section 3.5 the ethical considerations for our project are discussed, and our

applications to Ethics Committees/Health Organisations for approval to carry out our

studies are outlined. Ethical considerations that were not considered in our initial

application/s and were bought to our attention by the committees are discussed.

In the above Sections we also discuss the difficulties we encountered in

conducting our research project and any changes that we made to our methods as a

result.

3.1 METHODOLOGY AND RESEARCH DESIGN

3.1.1 Methodology

ARM 1

We sought to examine the current practice for obtaining informed consent for third

molar tooth extractions by oral and maxillofacial surgeons in Australia and New

Zealand by conducting a survey of practitioners.


Rationale

As outlined above in Section 2.2, historically the legal standard for risk disclosure had

considered the ordinary or accepted practice by a group of professionals (i.e. the

Bolam principle). This was later supplanted by a consideration only of the patient and

his/her preferences.

Obtaining data pertaining to the current practice for risk disclosure by oral and

maxillofacial surgeons provided a baseline of standard practice. This baseline was

compared to our suggested best practice for risk disclosure based on the evidence that

we accrued on the outcomes of legal cases and patient preferences (i.e. Arms 2 and 3

of the project). In making this comparison, we identify deficiencies in the current

practice of these practitioners. In devising a consent form for third molar tooth

extractions and presenting this to the medical community, we are suggesting what

changes to practice we consider important, and what modifications we think need to

be made to existing consent forms.

Particularly for those practitioners whose clinical practice deviates the most

from the findings of this study, the results may be an impetus for a change in their

practice, particularly given that it is not uncommon in cases involving risk disclosure,

for a practitioner to defend their action by stating their ‘invariable practice’.

While the survey included only oral and maxillofacial surgeons (the specialists

in third molar extractions), the final product of our project, the consent form, is

intended for use by both general dental partitioners and specialist surgeons. The

practice of specialists can be considered the ‘gold standard’ in practice (informed by

specialist knowledge).

Methodology

A survey was designed to determine the risks of third molar tooth extraction that oral

and maxillofacial surgeons from Australia and New Zealand include in their written

consent. The survey design is discussed in Section 3.3. Approval for the study was

gained from the QUT University Human Research Ethics Committee (UHREC) (as

outlined in Section 3.6).


The online survey was distributed by ANZAOMS via email to all full members

(i.e. consultant surgeons), followed by a reminder to non-responders nine days later.

For a particular risk with third molar extractions, we considered there to be

general agreement among surgeons that risk disclosure was required if ≥ 80% of

surgeons routinely included that risk in their written consent, or general agreement that

risk disclosure was not required if ≥ 80% of surgeons did not routinely include that risk

in their written consent.

ARM 2

We sought to locate and analyse judicial cases dealing with medical negligence in the

fields of general dentistry (oral surgery procedures) and oral and maxillofacial surgery.

Rationale

By locating and analyzing all publicly available Australian medical negligence

cases in this field, we identified those issues that have prompted litigation or been found

to be problematic by the courts. This informed us on the application of the legal

principles (i.e. the ‘reasonable patient’ and ‘particular patient’ standards) by the courts.

We drew on this analysis (and pertinent information from the medical literature) to

make findings that inform practitioners on managing legal risk, and that provide

evidence to guide third molar extraction risk disclosure. This information was then used

in drafting our third molar extraction consent form. Our examination of judicial cases

is the first to map litigation patterns in this key area of legal risk.

This arm of the study was particularly relevant for analyzing the ‘particular

patient’ legal standard (the subjective limb of the legal standard for risk disclosure). It

was useful to determine what information the courts required from a plaintiff/patient to

prove that they attach significance to a particular risk in light of their own values and

interests (i.e. in a case of failure to warn of a material risk, how the courts proved that

the practitioner failed to satisfy the ‘particular patient’ legal standard).

In this analysis we included all oral surgery/oral and maxillofacial surgery

procedures, rather than limiting our analysis to third molars extraction procedures only.

Firstly, there was a limited number of publicly available litigation cases dealing with


third molar tooth extractions (by general dentists or oral and maxillofacial surgeons).

Other oral surgery/oral and maxillofacial surgery procedures often carry some of the

same risks as third molar tooth extraction. Where legal cases inform us on decisions

regarding disclosure of a risk for one of those procedures, and the risk is also relevant

to third molars, the findings may then also to a degree be relevant to third molars. We

also published the findings of this arm of the project in a single paper, in which we

presented conclusions for all oral surgery/oral and maxillofacial surgery procedures.

This information was considered useful for its role in informing doctors/dentists

practicing a variety of oral surgery/oral and maxillofacial surgery procedures on ways

to better manage legal risk for those procedures.

Methodology

A systematic search was undertaken on the three main legal databases, Westlaw AU,

LexisNexis AU and AustLII, during January 2016 for published civil court cases

about medical negligence in the field of oral and maxillofacial surgery and general

dentistry (oral surgery procedures). Search terms used included ‘negligence’, ‘oral

surgery’, ‘dental surgery’, ‘maxillofacial surgery’, ‘dental implant’, ‘dental

extraction’ and combinations such as ‘negligence AND dentist AND surgery’. No

specific time period was set for the search. Each case identified through this search

was examined to determine its relevance and those outside the scope of the study were

excluded, e.g. where dental evidence was given in assault cases or other types of

negligence cases such as those involving motor vehicle accidents. Criminal court

cases were not included.

We undertook a detailed analysis of the cases meeting our inclusion criteria and

present summary data for each case in Table 7. A thematic analysis of the cases was

undertaken to determine trends.

ARM 3

We sought to determine patient preferences for risk disclosure for third molar tooth

extractions by conducting a survey of a cohort of participants with similar

characteristics to patients undergoing third molar tooth extractions (publicly or

privately) in the Australian community.


Rationale

As outlined above in Section 2.2, the legal standards for risk disclosure is the

‘reasonable patient’ and ‘particular patient’ standards outlined in Rogers v Whitaker.21

Such data on patient preferences in risk disclosure was expected to demonstrate in a

broad way, the types of risks that concern patients, and those that don’t, and therefore

provide some information on what a ‘reasonable patient’ would want to know. In

addition to other information it receives such as medical/dental evidence, the court

might consider this information when deliberating on cases involving failure to warn

of a material risk.

The data from this arm of the project and from Arm 2, informed what

risks we included in our third molar extraction consent form.

Methodology

A survey was designed to determine the risks of third molar tooth extraction that

participants would want to be warned of if undergoing the procedure. The survey design

is discussed in Section 3.3. Approval for the study was gained from the QUT UHREC

(as outlined in Section 3.6).

Students at QUT Gardens Point university campus were approached at random

over July-August 2017 and invited to participate in the study. Participants were advised

that their participation in the study was voluntary and that their response could not be

identified.

We had initially intended to distribute the surveys to patients in the clinical

setting, where the patient was to be given the survey prior to consultation with a

medical/dental practitioner for third molar extraction. Approval for the study was

gained from the Queensland Health Metro North Human Research Ethics Committee

and via Queensland Health site-specific approvals (as outlined in Section 3.6). Five

Queensland Health Metro South dental clinics, and the Ipswich Hospital Oral and

Maxillofacial Surgery Department agreed to participate in the project by distributing

surveys. Despite visiting each clinic individually to discuss the project with clinicians,


this was unable to be implemented due to time and energy constraints of those

clinicians.

Following our difficulties in distributing the surveys in the clinical setting, and

prior to deciding on the final distribution strategy outlined above, we had considered a

focus group for information acquisition. Data from a focus group would illustrate the

opinions of a small group of participants regarding their preferences for risk

disclosure, and may be biased towards the interests of those participants. The benefits

of the survey were that it had a much larger sample size.

3.1.2 Research Design

Our project was, for the most part, qualitative, although data gathered in Arms 1 and 3

were able to be analysed quantitatively using basic statistical methods. Formulating a

null hypothesis was not relevant to either study.

The data gathered in Arm 2 were presented entirely qualitatively. The specific

techniques that we used for collecting and recording data are presented in Section 3.4.

3.2 PARTICIPANTS

ARM 1

Participants were full members of ANZAOMS. There were no other

inclusion/exclusion criteria.

There is a finite number of consultant oral and maxillofacial surgeons in Australia

and New Zealand which limits the number of potential participants. The majority of

Australian and New Zealand oral and maxillofacial surgeons are members of

ANZAOMS.

ARM 2

This study did not involve participants.


ARM 3

Participants were students at the QUT Gardens Point university campus. This campus

has domestic and international students and offers courses in four disciplines of health:

medical radiation sciences, paramedic science, pharmacy and podiatry. It does not have

medical or dental students, who may bias the study, as their knowledge on the subject

matter may influence their response.

Students were not asked to confirm that they were students, but people who were

obviously not university students (such as staff with identification badges and high

school students in school uniform) were not invited to participate.

Participants were asked if they had ever had a wisdom tooth/third molar tooth

removed, or a consultation with a medical practitioner for this procedure. They were

invited to participate in the survey only if their answer was no. The purpose of this

inclusion criterion was to eliminate bias, given that participants who have previously

had the procedure performed, or been given information on the subject matter of the

survey may respond differently.

Given the paucity of existing research in this area, there was no data on which to

perform a power (sample size) analysis. We chose to distribute the survey to 220

participants.

3.3 INSTRUMENTS

ARM 1

A survey was designed to determine the risks of third molar tooth extraction that oral

and maxillofacial surgeons from Australia and New Zealand include in their written

consent (see Appendix 1).

We revised similar surveys published in the literature, as they dictate acceptable

survey design. The most relevant published survey was a study of consent for

orthognathic surgery amongst British surgeon published by McLeod NM et al.26 We

used this survey as a template and adopted the design insofar as it was relevant to our


project. To maximise the response rate, we aimed to keep the survey concise and

therefore collected only the data most relevant to answering the research question. The

instrument was relevant to Australia and New Zealand only given the scope of the

project as outlined in Section 1.4.

The only demographic information that we collected from participants was the

number of years of practice (full time-equivalent) as a consultant surgeon.

We firstly sought to determine whether there were any oral and maxillofacial

surgeons who perform third molar tooth extractions without first warning of risks. We

therefore asked surgeons in what percentage of cases of third molar tooth extraction

they gain informed consent (written and/or verbal).

The majority of the survey was directed at obtaining data on disclosure of specific

risks. Participants were asked to answer (yes/no) whether they routinely warned of a

specific risk with third molar extractions in their written consent. We divided the risks

into three groups ((1) vascular, infective and neurological complications, (2) technical

complications and (3) complications related to adjacent structures) as per the method

of McLeod NM et al.26 We felt that this division improved readability, and make the

survey easier to complete.

The survey was designed to best accommodate for the variability in surgeons’

written warnings of similar risks. Thus, it distinguished between general warnings (e.g.

bone fracture) and more specific warnings (e.g. maxillary tuberosity fracture, a type of

bone fracture).

Surgeons were able to comment if they routinely warned of any other risk with

third molar tooth extractions not included in the survey, and if they ever warn that the

procedure could be life threatening.

It is the view of this research team that the utilized questionnaire has face validity

(i.e. according to the responders, the survey measured what it intends to) and content

validity (i.e. that the survey actually measured what it intends to).

ARM 2

This arm did not utilize an instrument.


ARM 3

We sought to determine patient preferences for risk disclosure for third molar tooth

extractions by conducting a survey of a cohort of participants with similar

characteristics to patients undergoing third molar tooth extractions (publicly or

privately) in the Australian community.

In drafting the survey (see Appendix 2), medical expertise was provided by Associate

Professor Anthony Lynham, and medicolegal expertise was provided by Professor

Benjamin White. In constructing this instrument (as per the survey for Arm 1), we

carefully considered an appropriate survey length in order to obtain sufficient data to

achieve survey validity but avoid the disadvantages of a lengthy survey.

We first asked participants, in broad terms, how much information about third

molar extraction they would want to be given before making a decision on whether to

have that treatment (i.e. basic information, a moderate amount of information, or

extensive information). We also asked them whether or not provision of information

about rare risks of the procedure would cause them to feel very anxious and/or deter

them from having the treatment.

As per the survey in Arm 1, the majority of it was directed at obtaining data on

the specific risks of the procedure the participant would want to be warned of. The risks

of third molar extraction were presented in tabular format and participants were asked

to answer (yes/no/not understood) whether they would want to be warned of the

particular risk. Each risk was accompanied by a ‘lay explanation’ of that risk, and a

much as possible we avoided medical terminology (e.g. the risk of wound dehiscence

was listed as the risk of ‘splitting open of wound’).

We organised the risks of third molar extraction into the same format as the

survey in Arm 1 so that we could directly compare the data from the two surveys. As

per the survey in Arm 1, this survey distinguished between general warnings and more

specific warnings. Risks were not divided into three groups (McLeod NM et al

methodology) as per the survey in Arm 1 as that was a technical division that would

not be understood by participants. This survey was longer than the survey used in Arm

1, and required more time on behalf of participants to complete (mainly in reading the

‘lay explanations’). Our concern with a lengthy survey was that participants might not


use appropriate diligence in answering all the questions. To this end, not all risks

included in the survey in Arm 1 were included in this survey.

Risks that were excluded because they are the least common:

-temporary nerve injury other than inferior alveolar/lingual nerve injury (any warning,

including buccal nerve injury, mylohyoid nerve injury)

-permanent nerve injury other than inferior alveolar/lingual nerve injury (any warning,

including buccal nerve injury, mylohyoid nerve injury)

-displacement of teeth or roots into the inferior alveolar nerve canal

-oro-nasal communication and/or fistula

-aspiration or ingestion (any warning, including of tooth, tooth fragment, other material

or instrument)

-subcutaneous and/or tissue space emphysema.

Risks with additional reasons for exclusion:

-displacement of teeth or roots (general warning): not included due to difficulty in

providing a lay explanation

-unexpected soft tissue injury (any warning including lip or tongue laceration): not

included as it can be argued that this is a surgical mistake rather than a surgical risk

-temporomandibular joint complications (any warning): not included as they have not

been proven to result from third molar extractions

We included in this survey, but not in the survey in Arm 1, the risk of ongoing

pain from nerve damage, as although the risk is rare, we concluded in Arm 2 of the

project that it is an important risk to warn of. We also included in this survey the risk

of bony sequestra; this was omitted in error from the survey in Arm 1.

As per the survey used in Arm 1 of the project, it is the view of this research

team that the utilized questionnaire has face validity and content validity.

3.4 PROCEDURE AND TIMELINE

The project was performed in order, i.e. Arm 1, followed by Arms 2 and 3.


ARM 1

This was an online survey distributed via email link as outlined in Section 3.1.1. The

body of the email provided a synopsis of the project and invited surgeons to participate

by clicking on an embedded link. It directed participants to the attached participant

information sheet (email attachment). No compensation was provided to participants

for their time.

The survey was hosted by survey monkey. Data for each response was retrieved

individually, and manually added to an excel spreadsheet. Calculations were performed

on the excel spreadsheet.

ARM 2

The data was gathered by conducting a systematic search of the three main legal

databases as outlined in Section 3.1.1. All studies generated by the search were

reviewed independently by me. The titles and abstracts were reviewed, followed by the

full-text of those deemed potentially relevant, to assess the eligibility of the study for

inclusion according to the pre-defined criteria. Data was extracted from relevant studies

by using a standardized data extraction form. The selected studies were reviewed for

party names (plaintiff and defendant, sometimes called the ‘name’ or ‘title’ of the case),

year decided, judgement, adjudicating court, and damages awarded (if any).

ARM 3

The survey was distributed to participants at the QUT Gardens Point university

campus over July-August 2017 as outlined in Section 3.1.1. Students were approached

at random at central locations on the university campus (food court, main entrance,

and main lawn) on weekdays between 10am and 4pm during the study term and

invited to participate in the study. They were given a very brief verbal explanation of

the survey as part of the invitation to participate. The survey document provided

further written information about the survey and instructions for completion

(Appendix 2). Those who chose to participate were given a printed participant


information and consent sheet. A small snack was provided to participants as

compensation for their time.

Data for each response were retrieved individually, and manually added to an

excel spreadsheet. Basic calculations (means, percentages) were performed on the excel

spreadsheet.

Timeline

3 months Research design finalised

6 months Stage 2 proposal submitted

Survey of surgeons:

-Design completed

-Ethics approval obtained

-Data collected

Survey of patients:

-Design completed

9 months Survey of surgeons

-Manuscript submitted to the Australian Dental Journal

Analysis of litigation cases

-Systematic search on the legal databases for cases meeting our

search criteria

Survey of patients ethics approval obtained

-QUT ethics approval, Queensland Health ethics approval and site

specific approvals

12 months Analysis of litigation cases

-Manuscript submitted to the Australian Dental Journal

15 months Survey of patients

-Survey finalised


-Site visits to Metro South Oral Health Service dental clinics and

Ipswich Hospital Oral and Maxillofacial Surgery Department

completed

18 months

Survey of patients

-Difficulty implementing

24 months

Survey of patients

-Unable to obtain enough responses through distribution at clinical

sites

-QUT ethics approval amendment obtained for distribution to

students at QUT campus

26 months Survey of patients:

-Data collated

Draft evidence based consent form for third molar tooth

extractions completed

28 months

Finalised evidence based consent form for third molar extractions

completed

Thesis completed

3.5 ANALYSIS

Basis calculations only were used in Arms 1 and 3 (means, percentages). Statistics

were not required. In particular, we did not perform multivariate analyses. Because

we aimed to produce concise surveys to improve response rate, we did not collect

detailed demographic information, which could have been used for multivariate

analyses.

For Arm 2, the data were presented entirely qualitatively. Heterogeneity of data

was not a major issue for this study. Each case was unique and provided information

on legal decision making. Each case was presented with a case summary and

judgement. The level of the adjudicating court dictates to some extent the precedence


value the case holds for future cases of litigation. Therefore cases were reported

together with the adjudicating court.

3.6 ETHICS AND LIMITATIONS

Ethical considerations relevant to this research and ethics approvals required to conduct

Arms 1 and 3 of the project are outlined below. With regards to the limitations of the

project, which are stated below, it is relevant to consider that this area of medical

research currently has limited available evidence.

ARM 1

Ethical considerations

There were no risks to participants associated with undertaking the survey and

engagement in the project was voluntary. The survey was designed to be concise

(requiring approximately 15 minutes to complete) to minimise the time required on

behalf of participants.

The survey was conducted using Survey Monkey. Information provided by participants

was transferred to Survey Monkey's server in the United States of America. Participants

were advised of this on the participant information sheet and by answering the survey

it was implied that they agreed with this.

All comments and responses were anonymous (i.e. they could not be identified)

and they were treated confidentially. This was outlined on the participant information

sheet. The names of individual persons were not required in any of the responses.

Participants were advised that non-identifiable data from this project may be used as

comparative data in future projects or stored on an open access database for secondary

analysis.

All data collected as part of the project was stored securely as per QUT’s

Management of Research Data Policy (password locked computer and only available

to the principle investigator).


Limitations

The rationale for this arm of the project is outlined in Section 3.1.1. As stated, the data

does not provide direct evidence to guide risk disclosure, rather, it demonstrates current

standard practice. The results and conclusions of Arms 2 and 3 of the project were

compared with current practice to make recommendations for change. These

recommendations were implemented on the third molar extraction consent form.

ARM 2


There were no ethical considerations for this arm of the study.

Limitations

A methodological limitation of this study is that not all cases are indexed in the three

main legal databases, e.g. some district/county court cases may not have been located.

Further, this study only included disputes that were judicially resolved and did not

include claims settled outside of the courts. It is not possible to determine how many

legal claims are initiated but settled out of court, but it is likely to be the majority. Our

analysis is therefore based on what is likely to be a small percentage of the relevant

medicolegal disputes. Nevertheless, the cases analysed represent the apex of medical

negligence litigation and, as stated in Section 3.1.1, they inform how the courts apply

the legal principles regarding risk disclosure in cases of litigation.

ARM 3


Regarding our original methodology that involved distribution of the patient survey in

the clinical setting, the main ethical consideration was the possibility of discrepancy

between the information provided in the questionnaire, and the information provided


by the practitioner in the process of gaining consent for the procedure. We had planned

to ameliorate the risks by ensuring that the patient completed the questionnaire before

the practitioner provided any information on risks (e.g. while waiting for the

consultation). The patient would then have had the opportunity to discuss any questions

that arose from the questionnaire with the practitioner, and the practitioner could have

provided their own information to the individual patient. The Queensland Health Metro

North Human Research Ethics Committee commented during their review of our initial

application (outlined below), that they considered there to be a very low risk of legal

consequence for a practitioner should a complication arise that was mentioned in the

research questionnaire, but not during the practitioners risk disclosure. Our application

for ethics approval was amended to include this point.

For the final methodology, there were no risks to participating beyond the time

required to fill the survey. The survey was again designed to be concise, requiring

approximately 20 minutes to complete. As was the case for the survey in Arm 1,

participants were advised that their engagement in the project was voluntary, and that

all responses and comments collected were non-identifiable. Data was again stored

securely.

Limitations

Under the time constraints of a medical appointment (and similarly a survey), it

is impossible for a patient to fully appreciate all the risks of a medical procedure. A

complete understanding of a particular risk needs to involve knowledge of the incidence

of the risk, the likely severity of the complication (or impact on the patients life), and

the likely duration of that impact. It should also involve an understanding of the

treatment options for the complication, if there are any, and the ease or otherwise of

that treatment.

The deliberation of what risks a ‘reasonable patient’ and the ‘particular patient’

would want to be warned of is not one that is ever made by the patient (who never has

complete understanding of the risks). It is one made by the court, after their assessment

of what a ‘reasonable patient’ and the ‘particular patient’ would want to know. We

therefore do not purport to provide precise or definitive information on those risks that

a ‘reasonable patient’ would want to be warned of, and do not suggest that the data


trump the court’s decision, or that it is in any way legally binding. In making its

assessment, the court draws on community values and is informed of the risks etc

through the process of medical/dental evidence.

Nevertheless, the data collected on patient preferences for risk disclosure is still

useful. It provides some information for the courts to consider when making their

deliberation. It reveals, albeit in a broad way, the types of risks that concern patients,

and those that don’t. This may be one source of information for the court to consider in

addition to other information available to it.

ETHICS APPROVALS

To conduct the research, ethics approval was obtained from QUT and from Queensland

Health:

ARM 1

1. QUT UHREC (Approval number 1500001114)

Ethics approval to conduct the survey of surgeons was provided by this committee. The

application met the criteria for a low or negligible risk review under the National

Statement on Ethical Conduct in Human Research (2007).

ARM 3

1. QUT UHREC (Approval number 1500000528)

We gained ethics approval from this committee, initially, to conduct our survey of

patients in the clinical medical/dental setting. The application met the criteria for a low

or negligible risk review under the National Statement on Ethical Conduct in Human

Research (2007). A variation to the research project was approved by the Ethics

Committee prior to conducting our survey of participants at the QUT campus.

2. Queensland Health Approvals

For our original methodology, prior to conducting research at a Queensland Health

facility, we were required to seek ethics approval from a Queensland Health Ethics


Committee. We gained approval from the Queensland Health Metro North Human

Research Ethics Committee (Ref No. HREC/15/QRBW/115). The application was also

a low or negligible risk research application.

In addition, we were required to gain site-specific approvals to conduct research

at individual Queensland Health facilities. Two site-specific approvals were gained:

1. For the Queensland Health Metro South dental clinics, under the auspices of

Queensland Health Metro South. The following dental clinics has agreed to participate

in the project: the Queen Elizabeth Hospital Dental Clinic, Beenleigh Oral Health

Clinic, Logan Central Community Health Centre Dental Clinic, Browns Plains

Community Health Centre Dental Clinic, and Wynnum Hospital Dental Clinic.

2. For the Ipswich Hospital Oral and Maxillofacial Surgery Department, under the

auspices of Queensland Health West Moreton.

The site-specific approvals required an agreement between QUT and Queensland

Health, including agreement on intellectual property, and research data and materials.

Cecile Francis, Clinical Trial Manager at QUT, drafted the required documents, and

assisted in executing these agreements.

CONSENT FORM

There are several important limitations of the final evidence-based consent form.

Firstly, the consent form does not propose to dictate what the legal standard should be

for risk disclosure, but rather to guide appropriate information provision, given the best

available evidence. Secondly, it is important to bear in mind that a written consent form

does not eliminate liability for the risks cited as a patient may claim that they have not

been adequately informed of a particular risk to allow for a sufficient understanding of

it.

As stated in Section 1.4, the consent form is intended for use by Australian and

New Zealand practitioners only.

Chapter 4: Results 35

Chapter 4: Results

This chapter outlines our study results, which are presented for each arm of our project

separately.

ARM 1

Seventy-one (71) replies were received (39%). The respondents had practised as

qualified oral and maxillofacial surgeons in Australia/New Zealand or overseas for an

average of 17.8 years full-time equivalent. At the time of the survey, 70 of the

responding surgeons (99%) were performing third molar tooth extractions as part of

their practice while one was not, although the data for this surgeon was included in the

study. A small number of respondents did not complete all of the survey components

(see Tables 3-5).

All surgeons who responded to the question (67) gained verbal and/or written

consent for every third molar extraction performed. Seven (7) surgeons (10%) warned

their patients that one or more of the complications of third molar tooth extraction

could be life-threatening, while the others (64) did not.

Responses are shown in Tables 3– 5. The risks of third molar tooth extraction

are ranked in order from 1 to 30, according to the percentage of surgeons who

routinely included the risk in their written consent (highest to lowest). Where general

agreement among surgeons was achieved (≥ 80% of surgeons routinely included the

risk in written consent or ≥ 80% of surgeons did not routinely include the risk), the

risk is shown in bold in the tables below. General agreement items are listed in Table

6.

Table 3. Vascular, infective and neurological complications of third molar tooth

extractions. Number (%) of respondents who routinely included or did not

include the risk in their written consent, and total number of responders


Yes No Total Rank (out

of 30 risks)

Excessive bleeding (general warning) 50 (71) 20 (29) 70 6

Excessive bleeding (specific warning) - requiring additional surgery 12 (18) 56 (82) 68 21

Alveolar osteitis 36 (53) 32 (47) 68 9

Infection, not alveolar osteitis (general warning) 59 (84) 11 (16) 70 5

Infection, not alveolar osteitis (specific warning) - deep fascial space

involvement

12 (18) 54 (82) 66 20

Temporary inferior alveolar nerve injury 67 (97) 2 (3) 69 =1

Permanent inferior alveolar nerve injury 67 (97) 2 (3) 69 =1

Temporary lingual nerve injury 63 (91) 6 (9) 69 3

Permanent lingual nerve injury 60 (88) 8 (12) 68 4

Temporary nerve injury other than inferior alveolar/lingual nerve

injury (any warning, including buccal nerve injury, mylohyoid nerve

injury)

8 (11) 62 (89) 70 25

Permanent nerve injury other than inferior alveolar/lingual nerve

injury (any warning, including buccal nerve injury, mylohyoid nerve

injury)

5 (7) 63 (93) 68 27

Table 4. Technical complications of third molar tooth extractions. Number (%)

of respondents who routinely included or did not include the risk in their written

consent, and total number of responders


of 30)

Damage to adjacent tooth/teeth 42 (59) 29 (41) 71 8

Bone fracture (general warning) 28 (39) 43 (61) 71 14

Bone fracture (specific warning) - Fracture of the alveolus 11 (16) 59 (84) 70 22

Bone fracture (specific warning) - Maxillary tuberosity fracture 13 (19) 57 (81) 70 19

Bone fracture (specific warning) - Mandibular jaw fracture 25 (35) 46 (65) 71 15

Displacement of teeth or roots (general warning) 34 (48) 37 (52) 71 12

Displacement of teeth or roots (specific warning) - into the maxillary sinus 35 (49) 36 (51) 71 =10


Displacement of teeth or roots (specific warning) -into fascial spaces 5 (7) 65 (93) 70 28

Displacement of teeth or roots (specific warning) - into the inferior

alveolar nerve canal

6 (9) 64 (91) 70 26

Incomplete tooth/root removal 35 (49) 36 (51) 71 =10

Wound dehiscence 24 (34) 47 (66) 71 16

Periodontal defects 16 (23) 55 (77) 71 18

Unexpected soft tissue injury (any warning, including lip or tongue

laceration)

11 (15) 60 (85) 71 23

Bony sequestra 19 (27) 52 (73) 71 17

Table 5. Complications of third molar tooth extractions related to adjacent

structures. Number (%) of respondents who routinely included or did not

include the risk in their written consent, and total number of responders


of 30)

Oroantral communication and/or fistula 49 (69) 22 (31) 71 7

Oronasal communication and/or fistula 10 (14) 59 (86) 69 24

Temporomandibular joint complications (any warning) 29 (41) 42 (59) 71 13

Aspiration or ingestion (any warning, including of tooth, tooth

fragment, other material or instrument)

4 (6) 67 (94) 71 29

Subcutaneous and/or tissue space emphysema 1 (1) 69 (99) 70 30

Table 6. General agreement among surgeons that risk disclosure was required

(≥80% routinely included that risk in their written consent) or that risk

disclosure was not required (≥80% did not routinely include that risk)

GENERAL AGREEMENT THAT RISK

DISCLOSURE WAS REQUIRED

GENERAL AGREEMENT THAT RSISK DISCLOSURE WAS

NOT REQUIRED

Vascular, infective and neurological complications

Infection, not alveolar osteitis (general warning) Temporary nerve injury other than inferior alveolar/lingual nerve

injury (any warning, including buccal nerve injury, mylohyoid

nerve injury)


Temporary inferior alveolar nerve injury Permanent nerve injury other than inferior alveolar/lingual nerve

injury (any warning, including buccal nerve injury, mylohyoid

nerve injury)

Permanent inferior alveolar nerve injury Infection, not alveolar osteitis (specific warning) - deep fascial

space involvement

Temporary lingual nerve injury Excessive bleeding (specific warning) - requiring additional

surgery

Permanent lingual nerve injury

Technical complications

Bone fracture (specific warning) - fracture of the alveolus

Bone fracture (specific warning) - maxillary tuberosity fracture

Displacement of teeth or roots (specific warning) -into fascial

spaces

Displacement of teeth or roots (specific warning) - into the

inferior alveolar nerve canal

Unexpected soft tissue injury (any warning, including lip or

tongue laceration)

Complications of third molar tooth extractions

related to adjacent structures

Oronasal communication and/or fistula

Aspiration or ingestion (any warning, including of tooth, tooth

fragment, other material or instrument)

Subcutaneous and/or tissue space emphysema

Other complications of third molar tooth extraction that were not included in the

survey but which some respondents included in their written consent are listed

(number of respondents in parentheses):

(1) medication-related osteonecrosis of the jaw (MRONJ) and osteoradionecrosis

(osteonecrosis of the jaw in patients with a history of head or neck radiation) (2);

(2) allergic reactions to medications used during treatment (1);


(3) recurrence of odontogenic pathology (such as keratocystic odontogenic tumour)

associated with unerupted wisdom teeth (1);

(4) postoperative neuropathic pain (3) and nerve injury caused by local anaesthetic

injection (1);

(5) infection (specific warning) – sinus infection (1);

(6) food trapping (1);

(7) pericoronitis on the distal aspect of the lower second molars if the lower second

molars are incompletely erupted (1); and

(8) sensitivity of lower second molars (1).

The most significant complication of third molar extraction not included in the

survey was osteonecrosis of the jaw. It is a well-recognized and potentially serious risk

of tooth extraction. It only occurs in a well-defined subset of patients, i.e. patients with

current or past use of anti-resorptive agents (particularly bisphosphonates and RANK

(receptor activator of nuclear factor kappa B) ligand inhibitors), i.e. MRONJ, or a

history of head and neck radiation, i.e. osteoradionecrosis.

ARM 2

Our search revealed 15 cases of medical negligence in the field of oral and maxillofacial

surgery and general dentistry (oral surgery procedures) over a 20-year period (see Table

7). Litigation occurred in all Australian jurisdictions except for the Northern Territory,

and was conducted in the High Court of Australia, state Courts of Appeal and Supreme

Courts, as well as in various district/county courts. Eleven of these cases involved

determinations of whether or not the dentist or medical practitioner was negligent and

damages were awarded to patients in six of those cases. Awards of damages ranged

from over $1 000 000 to approximately $60 000 (although the latter case was 20 years

old).27, 28 Eight of the 15 cases involved general dental practitioners with the remaining

seven cases dealing with oral and maxillofacial surgeons (including one trainee). Of the

eight general dentist cases, seven involved molar tooth extractions (four relating

specifically to third molar), with the remaining case involving implant treatment. Cases

involving oral and maxillofacial surgeons were for orthognathic surgery (three cases)

and third molar tooth extraction (four cases). Of the eight cases about third molar tooth


extraction, there was nerve damage in four cases, postoperative infection in two cases,

prolonged and excessive postoperative discomfort in one case and temporomandibular

joint complication in one case. Of the three cases for orthognathic surgery there was

nerve damage in two of those cases and temporomandibular joint complication in one

case.

Table 7. Australian medical negligence cases in the field of oral and maxillofacial

surgery and general dentistry (oral surgery procedures)

Case Year

decided^

Case summary and judgement Court Damages

Robinson v Ng29 2014 - A general dentist displaced a tooth root into the

maxillary sinus during an upper right second molar

(17) tooth extraction

- The patient developed postoperative

osteomyelitis, facial pain and Bell’s palsy

- The causation for Bell’s palsy was not clear-cut

but the chance that the onset after the procedure

was a coincidence was considered low

Judgement: dentist negligent for continuing with

the procedure where a reasonably competent

dentist would have recognized that the risks of

continuing were outweighed by the benefit of

referral to a specialist or to a practitioner with

more experience.

Supreme Court

of the

Australian

Capital

Territory

$808 114

Banerjee v

Shah30

2012 - A general dentist extracted all of a patient’s

remaining teeth (20 periodontally involved teeth)

and placed dental implants and implant secured

bridges

- Due to the dentist’s admitted negligence there

were ongoing problems with that treatment

(including broken bridges and loose implants)

Judgement: negligence had been admitted so the

purpose of the trial was assessment of damages.

District Court of

Western

Australia

$401 459

Delphin v 2012 - A general dentist displaced a fragment of tooth Supreme Court $677 037


Martin31 into the soft tissue of the floor of the mouth during

extraction of an impacted lower right third molar

(48)

- The patient suffered permanent lingual and

inferior alveolar nerve damage

- No preoperative radiograph was taken

Judgement: dentist found negligent in (1) failing to

take a preoperative radiograph; (2) failing to warn

of the material risk of lingual nerve and inferior

alveolar nerve damage; and (3) use of excessive

force.

of Tasmania

Donmez v

Neissa32

2012 - The patient claimed that her head was held in an

extended position by a dental nurse during the

extraction which took more than one hour and that

this caused the injury (tooth number not reported)

- The patient also claimed that the adjacent tooth

was damaged during the procedure

Judgement: the issue in question was not

negligence but whether the patient was able to

bring the action due to the limitation of actions

statute. The absence of a further case on the

negligence issue suggests it was settled without

judicial resolution.

Supreme Court

of Victoria

Becke v

Nguyen33

2011 - A patient claimed that a general dentist was

negligent in extraction of his upper right first

molar (16) and upper right second molar (17) due

to the use of excessive force

- The patient also claimed that the general dentist

was negligent for failing to advise of alternative

treatment options, failing to take appropriate

preoperative radiographs and failing to provide

adequate follow-up treatment

- The patient was self represented at the trial

Judgement: General dentist not negligent.

County Court

of Victoria

No

damages

Hookey v

Paterno27

2009 - A patient underwent orthognathic surgery for

correction of a Class II malocclusion by an oral

and maxillofacial surgeon

- The patient suffered non-union of the osteotomy

Court of Appeal

of Victoria

$1 057 833


and permanent nerve damage with neuropathic

pain

Judgement: oral and maxillofacial surgeon

negligent in failing to warn of the material risk of

non-union of bone and of nerve damage. Special

leave to appeal to the High Court was refused.

Wilson v

Tier34

2008 - A patient developed a deep fascial space

infection following extraction of three third molar

teeth by an oral and maxillofacial surgeon

- It was claimed that the surgeon was negligent in

failing to promptly diagnose the postoperative

infection and treat those symptoms before the

infection spread to deep fascial spaces

Judgement: oral and maxillofacial surgeon not

negligent.

Supreme Court

of

New South

Wales

No

damages

Mulcahy v

Monsour35

2005 - A patient with a predisposing medical condition

(a ventricular peritoneal shunt) claimed she

suffered ongoing severe infections following

extraction of lower third molar teeth by an oral and

maxillofacial surgeon

Judgement: the claim was struck out by the court

because of delays in proceedings by the patient.

Supreme Court

of Queensland

Hyland v

Huen36

2004 - Following extraction of her upper left third molar

tooth (28) by a general dentist, a patient suffered

damage to her left temporomandibular joint

leading to ankylosis of that joint which required

surgical treatment

Judgement:

Trial judge – dentist negligent in failing to warn of

the material risk of infection and the availability of

antibiotics to prevent infection. This caused the

damage suffered.

Court of Appeal – set aside the judgement of the

trial judge and ordered a retrial.

The absence of the retrial suggests this dispute was

settled without judicial resolution.

Court of Appeal

of the

Australian

Capital

Territory


Royal Dental

Hospital of

Melbourne v

Akbulut37

2002 - A patient suffered permanent bilateral lingual

nerve damage following extraction of her lower

left and right impacted third molars (38 and 48) by

an oral and maxillofacial surgeon trainee

Judgement: oral and maxillofacial surgeon trainee

negligent in surgical technique and negligent in

failing to advise in a timely fashion of the

possibility for remedial surgical intervention for

the nerve damage suffered.

Court of Appeal

of Victoria

$371 500

Rosenberg v

Percival38

2001 - A patient suffered severe temporomandibular

joint complications following an osteotomy

performed by an oral and maxillofacial surgeon

- The patient had severe pain and difficulty eating

and drinking


failing to warn of the risk of temporomandibular

joint complications


negligent. Failed to establish causation.

High Court of

Australia

No

damages

Jung v Son39 1998 - Patient claimed general dentist negligent in

extraction of the lower left third molar (38) due to

prolonged and excessive postoperative discomfort

- The dentist failed to take a preoperative

radiograph

Judgement:

- Trial judge found no material increase in risk of

injury due to failure to take an X-ray

- Court of Appeal found that the trial judge had

erred because he had failed to give reasons for his

decisions on this issue of causation

The absence of the retrial suggests this dispute was

settled without judicial resolution.

Court of Appeal

of New South

Wales

McKellar v

Blake40

1998 - A patient suffered permanent left inferior

alveolar nerve damage after extraction of all four

third molar teeth by an oral and maxillofacial

surgeon (18, 28, 38 and 48)


Court of Appeal

of New South

Wales

No

damages


failing to warn of the risk of permanent inferior

alveolar nerve damage

- The surgeon defended the claim based on his

‘invariable practice’ which was to verbally warn of

the risk of inferior alveolar nerve damage, rather

than documented evidence of risk disclosure


negligent. Failed to establish causation.

Anderson v

Bowden 41

1997 - A patient suffered left lingual nerve damage

following extraction of four impacted third molar

teeth (18, 28, 38 and 48) by a general dentist

- It was claimed that the dentist was negligent in

failing to warn of the risk of permanent lingual

nerve damage and was negligent in surgical

technique, including the use of excessive force

Judgement: Dentist not negligent. Found that a

warning of permanent lingual nerve damage was

not given but failed to establish causation.

Supreme Court

of

Western

Australia

No

damages

Hribar v

Wells28

1995 - A patient had orthognathic surgery by an oral and

maxillofacial surgeon to correct a malocclusion

- The patient suffered permanent nerve damage

and persistent severe pain following the operation

Judgement: oral and maxillofacial surgeon

negligent in failing to warn of the material risk of

permanent and painful nerve damage

Supreme Court

of

South Australia

$61 489.50

ARM 3

We collected 218 responses. A small number of respondents did not answer all of the

survey components (see Table 8). 121 of the respondents (56%) were males and 91

were females. Their average age was 21.2 years.

Approximately half of the respondents (110) preferred to have moderate

information about wisdom tooth removal before making a decision about whether to

have that treatment. 44 respondents preferred to be given basic information, while 64

preferred to be given extensive information. Responses are shown in Table 8. The


risks of third molar tooth extraction are ranked in order from 1 to 22 (i.e. highest to

lowest), according to the percentage of participants who want to be warned of that

risk.

Half of the respondents (109) said that being provided with information about

rare risks of wisdom tooth removal would not cause them to feel ‘very anxious’ about

the procedure, however half of the respondents said that it would either cause them to

feel ‘very anxious’ (73), or that they were unsure (36). Regardless of whether it would

cause them to feel ‘very anxious’, the majority of respondents (150, 70%) said that

information about rare risks of wisdom tooth removal would not deter them from

having the procedure. Only 22 respondents (10%) said that it would deter them from

having the procedure, although 43 were unsure (20%).

Respondents who preferred basic information wanted to be warned of 12.5 of

the 22 risks included in the survey (57%) on average (range 5-22); 1 wanted to be

warned of all the risks included in the survey. Respondents who would like a

moderate amount of information want to be warned of 13.7 out of the 22 risks

(62.2%) on average (range 3-22). Of these respondents, 15 wanted to be warned of all

of the risks included in the survey. Those respondents who preferred extensive

information wanted to know on average 17.3 of the 22 risks (78.7%) (range 5-22); 24

of them wanted to be warned of all of the risks included in the survey.

Where general agreement among respondents was achieved for warning of a

risk (≥ 60% of respondents wanted to be warned of that risk), the risk is highlighted.

There were no risks where general agreement among respondents was achieved for

not wanting a warning (≥ 60% of respondents did not want to be warned of that risk).

Table 8. Number (%) of respondents wanted to be warned of the particular risk

with third molar tooth extractions prior to deciding whether to have the

procedure.

Yes No Not understood Rank (out

of 22 risks)

Excessive bleeding (217) 179 (82) 37 (17) 1 (0) 3


Excessive bleeding where you

need further treatment (217)

155 (71) 3 (1) 59 (27) 7

Dry socket (217) 197 (91) 18 (8) 2 (1) 1

Infection (216) 194 (90) 21 (10) 1 (0) 2

Deep infection (217) 151 (70) 65 (30) 1 (0) 8

Temporary numbness of your lip (217) 168 (77) 49 (23) 0 (0) 4

Permanent numbness of your lip (218) 150 (69) 66 (30) 2 (1) 10

Numbness of your tongue or change to taste that is temporary (218) 158 (72) 59 (27) 1 (0) 6

Numbness of your tongue or change to taste that is permanent (218) 136 (62) 79 (36) 3 (1) 12

Damage to nearby tooth/teeth (217) 134 (62) 83 (38) 0 (0) 14

Break in the bone (bone fracture) (218) 135 (62) 82 (38) 1 (0) 13

Break of the part of the jaw bone

that holds the roots of your teeth in

place (218)

113 (52) 3 (1) 102 (47) 20

Break of the jaw bone behind your

top wisdom tooth (218)

129 (59) 1 (0) 88 (40) 17

Break all the way through your

lower jaw (218)

104 (48) 3 (1) 111 (51) 22

Tooth or root pushed into the maxillary sinus (218) 134 (61) 85 (39) 3 (1) 15

Tooth or root pushed into an area of the face around the mouth (218) 108 (50) 103 (47) 7 (3) 21

Incomplete tooth/root removal (217) 131 (60) 85 (39) 1 (0) 16

Splitting open of wound (217) 166 (76) 50 (23) 1 (0) 5

Gum defects (217) 121 (56) 95 (44) 1 (0) 18

Bony sequestra (217) 150 (69) 65 (30) 2 (1) 9

Hole into maxillary sinus (216) 118 (55) 95 (44) 3 (1) 19

Ongoing pain from nerve damage (217) 137 (63) 76 (35) 4 (2) 11

Chapter 5: Analysis 47

Chapter 5: Analysis

This chapter discusses the results of each arm of our project separately and then draws

together this information to discuss its relevance to drafting the third molar consent

form.

ARM 1

The results of the study show that there is variability among Australian and New

Zealand oral and maxillofacial surgeons regarding risk disclosure for third molar

tooth extractions. Studies of consent for other procedures both in the field of oral and

maxillofacial surgery (orthognathic surgery) and other surgical fields show similar

findings.26, 42 The only risks that surgeons agreed should be routinely included in

written consent were a general warning of infection (not alveolar osteitis), inferior

alveolar nerve damage (temporary and permanent) and lingual nerve damage

(temporary and permanent).

Limitations of the study include the possibility of non-response bias (difference in the

estimate provided by the respondents’ vs the population estimate).52 No comparison

between responders and non-responders was possible, as the research team was

unable to collect covariate information for the non-responders. Surveys of

professionals (especially health professionals) generally have low response rates, with

rates less than 33% not uncommon. Further, a low response rate does not necessarily

impart substantial bias(es), as the survey was not of the general population but rather

of a specific target population that is more homogenous.52

ARM 2

In the following Section we discuss litigation risks that were identified in the case

review. We have included additional cases that were not identified by our systematic

literature search, and additional information from the literature where it supports the

discussion.


Consent and warning about risks

Our review highlights seven cases involving failure to warn of a material

risk.27,28,31,36,38,40,41 It appears particularly important to warn of the risk of permanent

nerve damage and postoperative neuropathic pain (Hookey v Paterno27 and Hribar v

Wells28) for relevant procedures, and the risk of postoperative infection. While

postoperative neuropathic pain occurred in cases involving orthognathic surgery (both

compensated), it may be prudent to warn of this risk for any surgery with the risk of

nerve damage.

For nerve damage associated with inferior alveolar nerve blocks, there was one

judgement (albeit of limited precedent value) which concluded that this risk need not

be warned about.43

The need or otherwise of the proposed treatment should be borne in mind. The

requirement for disclosure of risks is greater for cosmetic procedures (e.g.

orthognathic surgery for cosmetic purposes only) and for procedures where the need

is less critical (e.g. prophylactic third molar tooth removal). In McKellar v Blake40

(third molar tooth removal) the patient’s primary concern was cosmetic (crowding of

teeth) and this was critical in establishing causation for failure to warn of the risk of

nerve damage at the trial (i.e. establishing that the patient would not have undergone

the procedure if warned of the risk), although the decision regarding causation was

overturned at the appeal.

While there is a limited legal basis for discussing the statistical risk of

complications with patients, this information helps to guide clinicians in the consent

process. In a number of the cases analysed, the courts considered the incidence of a

risk in determining whether it was material.27, 38, 41

Referral to another dentist/specialist

There is case law authority that suggests medical practitioners should consider

disclosing to a patient the opportunity for a more experienced practitioner to

undertake the procedure.44 General dental practitioners, too, should consider whether

to offer patients referral to a more experienced practitioner or a specialist for complex

oral surgery procedures, particularly those beyond their level of skill or experience.

This may include referral during a procedure, particularly where it becomes clear that

the risks of proceeding outweigh the benefits.29 For some procedures, there may be a

similar duty for specialists as well. The reason for the referral, namely to reduce risks


of harm, should be explained in all cases.29

In emergency oral surgery, where a patient may be suffering significant pain, a

dentist may feel compelled to perform a procedure or persevere with a procedure,

where the patient would benefit from referral. In Robinson v Ng,29 a general dentist

was found to be negligent for failing to abort an emergency tooth extraction and refer

the patient to either a specialist or a general dentist with more experience, when it

became clear that it was problematic. Of note in this case was that the patient

expressly wanted to continue with the extraction, but negligence was still found as,

although the dentist raised the issue of referral, he did not clearly explain that a

referral would reduce the risks of complications.

Treatment/procedure

Negligence may be claimed for an inappropriate treatment plan, inappropriate surgical

technique/equipment or for insufficient skills and experience required to perform a

procedure. Dentists who have limited experience for a particular oral surgery

procedure should be mindful that the courts will often refer to a dentist’s history of

practice for that procedure. This is particularly pertinent for oral surgery, where

Australian university dental degrees often provide insufficient training to perform

complex procedures on graduation. For complex tooth extractions (particularly third

molars), general dentists can augment their skills over time, or they can undertake

additional training.

In Hookey v Paterno,27 the trial judge found the surgeon negligent in advising

an inappropriate treatment plan (orthognathic surgery). Two of three judges from the

Court of Appeal did not agree that the treatment plan was inappropriate, although the

appeal was dismissed on the basis of failure to warn of a material risk.

Dental practitioners should also consider the possibility of a claim related to

‘loss of chance’ for specialist opinion in oral surgery treatment planning. In Banerjee

v Shah,30 a case of full dental clearance due to advanced periodontal disease, the judge

noted that a review by a specialist periodontist regarding the possibility of retaining

some teeth did not occur.

In Delphin v Martin31 and Royal Dental Hospital of Melbourne v Akbulut,37 the

practitioners were negligent in surgical technique. In the former case, this was due to

the use of excessive force during a third molar tooth extraction. It was also claimed in

this case that the dentist used an inappropriate (non-surgical) drill, although the judge


made no finding on this matter. In the latter cases, the damages awarded were for loss

of future earnings as a singer and psychological damage suffered. In Banerjee v

Shah,30 a case where negligence was admitted, the general dentist was unsuccessful in

attempting full mouth rehabilitation with dental implants and implant-supported

bridges (there were loose implants and broken bridges).

The litigation hazards for a second practitioner (often a specialist) completing a

failed procedure before the local anaesthetic administered by the first practitioner

wears off has been previously referred to in the literature.45 This is particularly

relevant for the risk of nerve damage, where it can be difficult to establish the timing

of the injury.

Follow-up

The legal duty of care to the patient continues well after the doctor-patient interaction,

irrespective of whether there is initiative taken on the part of the patient for their own

health care. Several medical court cases (most notably Tai v Hatzistavrou46 and Kite v

Malycha47) highlight the necessity of appropriate and timely follow-up of

investigations, referrals and procedures. The duty cannot be ended by the will of the

doctor; it continues until the patient no longer requires treatment, or until the doctor-

patient relationship is formally dissolved by either party.48

In respect of oral surgery procedures, it is important to follow up patients

regarding postoperative complications. Our review highlighted the importance of

follow-up for severe postoperative infection and neurological damage. In one case

(Royal Dental Hospital of Melbourne v Akbulut),37 a trainee surgeon was found

negligent for failing to advise a patient in a timely fashion of the possibility for

remedial surgical intervention for nerve damage sustained.

Diagnosis

Case law concerning failure of diagnosis has focused on failure to diagnose cancer. It

came into focus in the case of O’Shea v Sullivan where a general medical practitioner

failed to diagnose a cervical cancer.49 All dental practitioners (including surgeons)

should routinely screen for oral cancer. A long delay in diagnosis of oral cancer was

associated with poor defence outcomes in a US review.50

In Wilson v Tier,34 an oral and maxillofacial surgeon was taken to court over a

claim that he failed to diagnose and treat a postoperative infection before it spread to


the deep fascial spaces, although no damages were awarded because he was not found

negligent.

Medical records

Quality medical records are a crucial part of medical and dental practice, not only for

continuity and quality of care and efficiency of treatment, but for their use in

litigation.

In Hribar v Wells,28 McKellar v Blake40 and Delphin v Martin,31 cases involving

failure to warn of a material risk, the practitioners defended the claims on the basis of

‘invariable practice’, rather than documented evidence of risk disclosure, and were all

unsuccessful on this point. In Hribar v Wells28 and Delphin v Martin,31 the judges

preferred the version of events claimed by the patient and in both cases felt that there

was a significant degree of reconstruction in the practitioners’ evidence. In McKellar

v Blake,40 the trial judge accepted that the surgeon would have given a warning, but

concluded that it was not sufficient to allow the patient to make an informed choice.

(This conclusion was not disturbed on appeal, although the surgeon successfully

appealed on other grounds.)

Radiographs

It is widely accepted within the dental community that a practitioner should view a

preoperative radiograph that visualizes the root structure prior to embarking on any

tooth extraction. While this view has generally been adopted by the courts (Delphin v

Martin31 and Jung v Son39), in Becke v Nguyen,33 failure to take a preoperative

periapical or panoramic radiograph prior to extraction of two periodontally involved

teeth was not considered inappropriate (although the patient was self-represented at

the trial).

Interestingly, in Delphin v Martin,31 the judge determined that the duty of care

required the dentist not to extract the lower third molar tooth without first viewing a

panoramic X-ray, even though a periapical (intraoral) radiograph had been taken. This

judgement was based on expert evidence regarding the limitations of the periapical

radiograph to indicate the position of the inferior alveolar nerve.

Extraoral radiographs, including panoramic radiographs and computed

tomography (CT), are being increasingly utilized by dental practitioners for oral

surgery procedures, and improved affordability has meant that many dentists now


have extraoral X-ray equipment in their own practices.51 Practitioners should consider

the associated medico-legal risks, particularly relating to radiation dose and the

possibility of a claim for failure to diagnose, i.e. where the survey reveals pathology

that is not diagnosed either because the dental practitioner is not familiar with the

pathology and/or the entire data set is not examined. Dental practitioners who capture

their own extraoral images should consider whether the survey ought to be examined

by a dentomaxillofacial radiologist, where available, particularly for CT images where

the risks are greater.51

ARM 3

There was less variation in the proportion of participants who wanted to be warned of

different risks compared with the variation in the proportion of surgeons who

disclosed those risks (range of 48% to 91% for the proportion of participants who

wanted to be warned of different risks; range of 7% to 97% for surgeons’ warnings

for those risks, i.e. those risks that were included in the patient survey). As discussed

in Section 3.6 (limitations), this is likely to be driven by (1) the fact that the

information provided in the patient survey (on incidence, and explanation of the risk),

did not give the respondent a complete understanding of the risk and (2) actual

differences in the preferences of participants compared with surgeons decisions

regarding risk disclosure.

The risks that surgeons warned of most frequently were inferior alveolar and

lingual nerve injuries (temporary and permanent inferior alveolar nerve injury ranked

equal first out of 30 risks, while temporary and permanent lingual nerve injury ranked

third and fourth, respectively). The majority of surgeons that warned of those risks

told patients that it could be permanent. Thus, for inferior alveolar nerve damage, all

surgeons who warned of this risk, warned that it could be permanent. For lingual

nerve damage, 60 of the 63 surgeons who warned of the risk, warned that it could be

permanent. In comparison, participants wanted a warning of temporary nerve damage

to the inferior alveolar and lingual nerves relatively frequently (4 and 6 out of 22

risks, respectively). However, they less frequently wanted a warning that it could be

permanent (warnings of permanent damage to the inferior alveolar and lingual nerves

were ranked 10 and 12 out of 22 risks, respectively, and the risk of ongoing pain from


nerve damage was ranked 11). As outlined above, the risk of ongoing pain from nerve

damage was not included in the survey of surgeons (Arm 1).

Participants most frequently wanted a warning of conditions which impede

healing or recovery from the procedure in the early post-operative period; dry socket,

infection, and excessive bleeding, were ranked 1, 2, and 3, respectively, out of 22

risks. The proportion of surgeons who warned of these risks was the next highest after

nerve damage; these same risks were ranked 9, 5, and 6, respectively, out of 30 risks

by surgeons. The proportion of participants who wanted a warning of wound

dehiscence and bony sequestra (ranked 5 and 9, respectively, out of 22 risks) was

greater than the proportion of surgeons who warned of those risks (16 and 17,

respectively, out of 30 risks). The proportion of participants who wanted a warning

that excessive bleeding may require further treatment, or that infection may be deep

(i.e. deep fascial space infection) was also greater than the proportion of surgeons

who warned of those risks (ranked 7 and 8 respectively out of 22 risks by participants,

and ranked 21 and 20 respectively out of 30 risks by surgeons).

The proportion of surgeons who warned of the risks of oroantral

communication, damage to nearby teeth, incomplete tooth removal, and displacement

of tooth or root into the maxillary sinus, water greater than the proportion of

participants who wanted to be warned of those risks (ranked 7, 8 and equal 10,

respectively, out of 30 risks by surgeons, and ranked 19, 14, 16 and 15, respectively,

out of 22 risks by participants). Similarly, the proportion of surgeons who warned of

periodontal defects (a late healing concern) (18 out of 30 risks) was greater than the

proportion of participants who wanted to be warned of that risk (ranked 18 out of 22

risks). Similarly

The moderate number of participants wanted a general warning of the risk of

bone fracture, and this was similar to the proportion of surgeons who warn of the risk

(ranked 13 out of 22 risks by participants, and 14 out of 30 risks by surgeons).

However, less participants wanted a warning of the specific nature of the bone

fracture (tuberosity fracture, alveolar fracture, and mandibular jaw fracture),

compared to the proportion of surgeons who provide specific warnings.

The number of participants who wanted a warning of displacement of tooth or

root into the fascial spaces was small, as was the number of surgeons who warned of

that risk (ranked 21 out of 22 risks by participants, and 28 out of 30 by surgeons).


CONSENT FORM

Table 9 reports the elements of a third molar consent form that we consider important,

based on available medicolegal literature and/or our data collection. Some elements are

reported as optional and can be included or excluded by a practitioner depending on their

circumstances (for example, type of practitioner (general dentist vs specialist), type of

facility, and practitioner preference). Some practitioners, particularly private practitioners,

may prefer a shorter consent form.

Table 9. Elements of the patient information sheet/third molar consent form and the

evidence base for each element Element Evidence

Patient Information Sheet

Section on material risks:

(1) Alveolar osteitis

(2) Infection (general warning)

(3) Infection (specific warning) - deep infection

(4) Excessive bleeding (general warning)

(5) Excessive bleeding (specific warning) -

requiring additional treatment

(6) Wound dehiscence

(7) Bony sequestra

(8) Temporary lingual nerve injury

(9) Temporary inferior alveolar nerve injury

(10) Bone fracture (general warning)

(11) Oroantral communication

(12) Displacement of tooth or roots into the

maxillary sinus

(13) Permanent inferior alveolar nerve injury

(14) Permanent lingual nerve injury

(15) Neuropathic pain

Reasonable patient survey (1-10)

Litigation analysis (11-15)

Section on expected recovery Reasonable patient survey

Consent Form

Section on age Susarla SM et al9, AAOMS white paper,6 medical


Statement that the risks of the procedure increase with

age

principles

Section on occupation Particular patient legal standard21

Litigation analysis

Statement of patient’s condition Cavell R24

Statement on the proposed treatment

Cavell R24

Medical History:

Statement on perioperative plan for current use of

anticoagulants

Survey of surgeons, medical principles

Broad values only reported for incidence of risk

-Incidence categorised as common, uncommon, or rare

Litigation analysis

Section on the specific risks verbally discussed with the

patient

Litigation analysis

Medicolegal principles

Statement that the practitioner has considered that the

requirement for disclosure of risks is greater for removal

of third molar teeth when the indication for removal is

less clear

Litigation analysis

Section on the risks of not having the procedure Medicolegal principles

Section on alternative procedure, treatment,

investigation, or practitioner


Sections for the patient or substitute decision maker to

‘authorize’ the treatment

-Includes allowing for two people to authorise the

treatment

Cavell R24

Statement that the hospital/facility does not guarantee a

successful outcome

Cavell R24

Section on refusal of treatment



Optional Elements

Section on capacity


Section on interpreter/support person Medicolegal principles

Medical History:

Section on perioperative plan for anticoagulants

Section on the risks associated with current or past use of

anti-resorptive agents

Statement on the risks associated with a history head and

neck radiation to the operation site

Survey of surgeons, medical principles

Statement on provision of information regarding sedation

or general anaesthetic

-Intended for use by practitioner/facilities that offer

sedation or general anaesthetic


Section for the patient to record questions for the

practitioner and for the practitioner to record that they

have addressed each question.

-Intended for practitioners who do not mind a longer

consent form

Cavell R24

Statement on discussion of the relative risks of accepting

or declining a referral to a specialist for management

-Intended for use by general dentist

Litigation analysis

Section on practitioner who will perform procedure

-Intended for use by facilities where the person who

gains consent is the person who performs the procedure

OR

Statement that the practitioner who has discussed the

procedure with the patient is not necessarily the

practitioner who will perform the treatment.

(some public facilities)


Chapter 6: Conclusions 57

Chapter 6: Conclusions

This report has discussed our multi-stage research project which aimed to develop an

evidence-based third molar removal consent form for industry use.

This chapter outlines our conclusions for each arm of our study. We also

present our third molar consent form. It is intended as a gold standard for national use.

ARM 1

There is no universal agreement among Australian and New Zealand oral and

maxillofacial surgeons regarding risk disclosure for third molar tooth extractions. This

study has highlighted the need for a more consistent approach to risk disclosure for

third molar tooth extractions among surgeons.

ARM 2

Drawing on our review of the judicial cases considering medical negligence in the

field of oral and maxillofacial surgery and general dentistry (oral surgery procedures),

we make the following recommendations:

(1) Ensure adequate disclosure of material risks, including warnings of the risk of

postoperative infection, and for relevant procedures, the risk of nerve damage.

(2) Consider warning of the risk of neuropathic pain for any oral and maxillofacial

surgery/oral surgery procedure with the risk of nerve damage.

(3) In determining risks to disclose, take into consideration the incidence of the risk

and how necessary the treatment is. For example, consider that the requirement for

disclosure of risks is greater for removal of third molar teeth when the indication for

removal is less clear (eg to prevent crowding, or prophylactic removal).

(4) In determining risks to disclose, consider the patient’s occupation and hobbies.


(5) Strongly consider referral for all complex oral surgery procedures in the general

dental setting and discuss the relative risks of accepting or declining the referral.

(6) In the general dental setting, always assess whether you have sufficient skills and

experience for an oral surgery procedure.

(7) Ensure adequate follow-up of postoperative complications. Advise patients of the

possibility of surgical intervention for nerve damage sustained.

(8) Keep quality medical records. In particular, adequately document risk disclosure

for oral surgery/oral and maxillofacial surgery procedures. It is particularly important

to record what risks were verbally disclosed to the patient.

(9) Take an appropriate preoperative radiograph. If a periapical radiograph is used for

lower third molar tooth extraction, consider whether the angulation accurately reflects

the position of the inferior alveolar nerve. Strongly consider taking a panoramic X-ray

prior to removal of lower third molar teeth.

ARM 3

Drawing on the results of our patient survey we make the following recommendations

for risk disclosure for the ‘reasonable patient’:

(1) Comprehensively discuss complications of third molar tooth extraction that impede

healing or recovery from the procedure; ensure you give a warning of alveolar

osteitis, infection, excessive bleeding, wound dehiscence and bony sequestra.

(2) Ensure that you give a warning that excessive bleeding may require further treatment,

or that infection can spread to the deep tissues.

(3) Give a general warning of inferior alveolar and lingual nerve damage.

(4) Give a general warning of bone fracture. We recommend a general disclosure that it

could range from a small fracture of bone supporting just the roots of the tooth, to a

larger fracture of the upper of lower jaw.

CONSENT FORM

Name:DOB: Sex:Occupation:

A. Does the patient have the capacity to comprehend and sign?Yes No

B. Does the patient require an Interpreter/Support Person?Yes NoIf yes, interpreter/cultural support person (circle one) present ☐

C. Condition/TreatmentThe dentist/doctor has explained that I have the following condition (doctor/dentist to document in patient’s own words)[insert condition]

The dentist/doctor has proposed the following treatment (doctor/dentist to document in patient’s own words and include site/side)[insert treatment]

Will sedation or general anaesthetic be performed?Yes NoIf yes, information has been provided: ☐

D. Medical HistoryCurrent use of anticoagulants Yes NoIf yes, perioperative plan [insert] and bleeding risk has been discussed: ☐

Associated pathology (eg cyst, tumour)Yes NoIf yes, risks associated with pathology and/or its recurrence has been discussed: ☐

Current or past use of antiresorptive agent/sYes NoIf yes, the risk of medication-related osteonecrosis of the jaw has been discussed: ☐

History of head and neck radiation (to the site of procedure)Yes NoIf yes, the risk of radiation-associated osteonecrosis of the jaw has been discussed: ☐

E. Risks of wisdom tooth removal verbally discussed with patient (doctor/dentist to document every risk discussed verbally with the patient (even if the risk is written in the patient information sheet))[insert]

Authorization For Removal Of Wisdom Teeth

Copyright © 2017 E Badenoch-Jones, D Hutmacher, D Loesnner, JLynham,

If wisdom tooth removal is prophylactic (that is to prevent a future problem), the doctor/dentist has considered that it is more important to disclose the risks than if the wisdom tooth is casing a problem now (doctor/dentist to tick) ☐

F. Risks of not having the procedure (doctor/dentist to document risks of not having the procedure)[Insert]

G. Alternative procedure, treatment, investigation, or practitioner[insert]The relative risks of accepting or declining a referral to a specialist for management have been discussed: ☐

H. Practitioner who will perform the procedure (doctor/dentist to document the person who will perform the procedure, or if unknown, write ‘unknown’).[Insert]

I. AuthorizationI understand that the hospital/facility does not guarantee a successful outcome of the procedure.

I understand that the doctor/dentist does not guarantee a successful outcome of the procedure.

I understand that the practitioner who has discussed this procedure with me is not necessarily the practitioner who will perform the treatment. Not Applicable ☐

I authorize this treatment (the patient AND a substitute decision maker can authorize the treatment)Name of patient:Signature: Date:

I [insert substitute decision-maker name] authorize this treatment (the patient AND a substitute decision maker can authorize the treatment)Name of substitute decision maker:Relationship to the patient:Signature:Date:Phone number:

J. Refusal of treatmentI [insert patient’s name] have had the risks and benefits of the procedure explained to me and refuse this procedure:Name of patient:Signature:Date:

BACKGROUND

Wisdom teeth (also called ‘third molars’) are teeth at the very back of your mouth. There is one at the top and one at the bottom on each side of your mouth. They are usually the last teeth to push through the gums, although for some people there is no space in the mouth for the wisdom tooth, and it gets caught under the gum. Some people are missing one or more wisdom teeth.

Your doctor or dentist may decide that you would benefit from having your wisdom tooth/teeth removed. This will be because the wisdom tooth is causing a problem, or because the tooth could cause a problem in future.

Problems caused by wisdom teeth:-infection of the gum around the tooth, or development of a deeper infection -cavities or fracture of the tooth: because of their location, wisdom teeth are prone to cavities and fracture-gum pockets around the wisdom tooth-food trap: food can get caught around the wisdom tooth-damage to an adjacent tooth-occasionally there can be a cyst or tumour associated with the wisdom teeth -wisdom teeth can interfere with jaw surgery

There are risks and complications of wisdom tooth removal. The risks of wisdom tooth removal are lowest when you are young and increase with age. Common risks are those with >1% chance of happening. Uncommon risks are those with 0.1-1% chance of happening. Rare risks have <0.1% chance of happening.

RISKS

-Dry socket: a painful condition where the blood clot (clump of blood) is lost from the socket too early (Common).

-Infection: an infection could develop at the site of tooth removal (Common).

-Deep infection: the infection can spread deep into your face or neck and cause swelling (Uncommon). You can feel

very sick and sometimes the swelling can make it hard for you to breath (Rare). Therefore you may need to be

treated in a hospital if this happens.

-Excessive bleeding: you can bleed more than expected during or after the procedure (Common). You may require

further treatment to stop the bleeding (Uncommon).

-Splitting open of wound: Your doctor or dentist may place stitches in your gum to hold the wound together. The

wound can split open, often because of an infection, or if the stitches are lost (Uncommon).

-Bony sequestra: a very small piece of dead bone can appear through your gum sometime after the procedure. It

doesn’t usually cause much trouble (Common).

-Nerve damage: you would notice this as numbness of your tongue or lip, or change to taste on the side where your

wisdom tooth is removed. It will take a number of months to go away (Common) or it can be permanent

(Uncommon to Rare). If you experience permanent nerve damage, in a very rare case you could experience ongoing

pain from the nerve that may be hard to treat.

-Break in the bone (bone fracture): there can be a small break (of the bone holding just the roots of the tooth) that

does not require treatment (Common), or a bigger break of your upper or lower jaw bone (Rare for bottom wisdom

tooth, uncommon for top wisdom tooth). If a break occurs all the way through your lower jaw bone, it normally

occurs after the procedure with the force of eating, because the bone is weakened by removal of the tooth.

-Hole into maxillary sinus or tooth/fragment pushed into maxillary sinus: there is an air pocket in your top jaw called

your maxillary sinus. This air pocket drains into your nose and gets congested when you get sick. The roots of your

top wisdom tooth may be close to your maxillary sinus. If this is the case, after tooth removal there can be a hole

into the sinus (Uncommon). You would usually need a procedure to fix the hole. -A tooth (or tooth fragment) can be

pushed into the sinus. You would then need a procedure to remove it from the sinus (Uncommon).

Every wisdom tooth is different. While removal of some wisdom teeth causes significant pain and swelling afterwards,

others can be removed without causing you much discomfort.

Patient Information – Wisdom Tooth Removal

Copyright © 2017 E Badenoch-Jones, D Hutmacher, D Loesnner, JLynham,

EXPECTED RECOVERY

(doctor/dentist to document expected recovery)

[Insert]

QUESTIONS YOU HAVE FOR YOUR DOCTOR/DENTIST

ABOUT WISDOM TOOTH REMOVAL

(doctor/dentist to tick if discussed)

[Insert] ☐

[Insert] ☐

[Insert] ☐


Publications Arising From This Project

(1) Badenoch-Jones EK, Lynham AJ, Loessner D. Consent for third molar tooth

extractions in Australia and New Zealand: a review of current practice. Aust Dent J

61(10):203-207, 2016.

(2) Badenoch-Jones EK, White BP, Lynham AJ. The Australian litigation landscape -

oral and maxillofacial surgery and general dentistry (oral surgery procedures): an

analysis of litigation cases. Aust Dent J 61(3): 310-6, 2016.

Bibliography 61

Bibliography

1. Lam R. Minimally legally invasive dentistry. Aust Dent J 2014;59:432–438.

2. Khoury BS, Khoury JN. Consent: a practical guide. Aust Dent J 2015;60:138–

142.

3. Health Workforce Australia 2014: Australia's Future Health Workforce - Oral

Health - Overview.

4. Mann T, Blunden A. Australian Law Dictionary. 2nd edn. Oxford University

Press, 2010. .

5. National Institute for Health and Care Excellence. Guidance on the Extraction

of Wisdom Teeth 2000. URL: ‘https://www.nice.org.uk/guidance/ta1'. Accessed July

2015.

6. American Association of Oral and Maxillofacial Surgeons. White Paper:

Management of Third Molar Teeth 2016, URL:

‘https://www.aaoms.org/docs/govt_affairs/advocacy_white_papers/management_third

_molar_white_paper.pdf'. Accessed November 2016.

7. Bouloux GF, Steed MB, Perciaccante VJ. Complications of third molar surgery.

Oral Maxillofac Surg Clin North Am 2007;19:117–128.

8. Marciani RD. Complications of third molar surgery and their management.

Atlas Oral Maxillofac Surg Clin North Am 2012;20:233–251.

9. Susarla SM, Blaeser BF, Magalnick D. Third molar surgery and associated

complications. Oral Maxillofac Surg Clin North Am 2003;15:177–186.

10. Australian Government. National Health and Medical Research Council.

General Guidelines for Medical Practitioners on Providing Information to Patients.

URL: ‘http://www.nhmrc.gov.au/_files_nhmrc/publications/attachments/e57.pdf'.

Accessed January 2015.

11. Layton SA. Informed consent in oral and maxillofacial surgery: a study of its

efficacy. Br J Oral Maxillofac Surg 1992;30:319– 322.

12. Dawes PJD, O’Keefe LO, Adcock SD. Informed consent: the assessment of two

structured interview approaches compared to the current approach. J Laryngol Otol

1992;106:420–424.

Bibliography 62

13. Hekkenberg RJ, Irish JC, Rotstein LE, Brown DH, Gullane PJ. Informed

consent in head and neck surgery: how much do patients actually remember? J

Otolaryngol 1997;26:155–159.

14. Brons S, Becking AG, Tuinzing DB. Value of informed consent in surgical

orthodontics. J Oral Maxillofac Surg 2009;67:1021– 1025.

15. Layton SA, Korsen J. Informed consent in oral and maxillofacial surgery: a

study of the value of written warnings. Br J Oral Maxillofac Surg 1994;32:34–36.

16. Lavelle-Jones C, Byrne DJ, Rice P, Cuschieri A. Factors affect- ing quality of

informed consent. BMJ 1993;306:885–890.

17. Butler D, Cockburn T, Yule J. In: White B, McDonald F, Willmott L, eds.

Health Law in Australia. 2nd edn. Sydney: Thomson, 2014:255–370.

18. Bolam v Friern Hospital Management Committee [1957] 1 WLR 582.

19. Sidaway v Board of Governors of Bethlem Royal and the Maudsley Hospital

[1985] 2 WLR 480.

20. Bolitho v City and Hackney Health Authority [1997] 3 WLR 1151.

21. Rogers v Whitaker (1992) 175 CLR 479.

22. Chester v Afshar [2004] UKHL 41 Pt 2.

23. Skene L. Law and Medical Practice: Rights, Duties, Claims and Defences. 2nd

edn. Sydney: LexisNexis, 2004:182.

24. Cavell R. Towards a better consent form. J Law Med. 2007;14:326-338. .

25. Australian and New Zealand Association of Oral and Maxillo- facial Surgeons.

Wisdom Teeth and What To Do About Them [pamphlet]. Camberwell: Mi-tec Medical

Publishing, 2010.

26. McLeod NMH, Gruber EA. Consent for orthognathic surgery: a UK

perspective. Br J Oral Maxillofac Surg 2012;50:e17–e21.

27. Hookey v Paterno [2009] VSCA 48.

28. Hribar v Wells (1995) 64 SASR 129.

29. Robinson v Ng [2014] ACTSC 227.

30. Banerjee v Shah [2012] WADC 28.

31. Delphin v Martin [2012] TASSC 13.

32. Donmez v Neissa [2012] VSC 73.

33. Becke v Nguyen [2011] VCC 1200.

34. Wilson v Tier [2008] NSWSC 92.

35. Mulcahy v Monsour [2005] QSC 348.

63

36. Hyland v Huen [2004] ACTCA 5.

37. Royal Dental Hospital of Melbourne v Akbulut [2002] VSCA 88.

38. Rosenberg v Percival [2001] HCA 18.

39. Jung v Son [1998] NSWSC 698 (Court of Appeal).

40. McKellar v Blake [1998] NSWCA 153.

41. Anderson v Bowden [1997] WASC (Unreported).

42. McManus PL, Wheatley KE. Consent and complications: risk disclosure varies

widely between individual surgeons. Ann R Coll Surg Engl 2003;85:79–82.

43. Mazurkiewicz v Scott (1996) 16 SR(WA) 162.

44. Chappel v Hart (1998) 195 CLR 232.

45. Dohvoma C, Hutchison I. Litigation hazards following failed extractions. Br

Dent J 1993;174:389.

46. Tai v Hatzistavrou [1999] NSWCA 306.

47. Kite v Malycha (1998) 71 SASR 321.

48. Andrews S, Barrett M. Perceptions of responsibility for clinical risk

management: evidence from orthopaedics practitioners, practice managers and patients

in an Australian capital city. J Law Med 2003;11:48–58.

49. O’Shea v Sullivan (1994) Aust Torts Reports 81-273.

50. Lydiatt DD. Cancer of the oral cavity and medical malpractice.

Laryngoscope 2002;112:816–819.

51. Wright B. Contemporary medico-legal dental radiology. Aust

Dent J 2012;57:9–15.

52. VanGeest JB, Johnson TP, Welch VL. Methodologies for improving response

rates in surveys of physicians: a systematic review. Eval Health Prof 2007: 30(4): 303-

321

Appendices 65

Appendices

Appendix 1 Survey ‘Consent For Third Molar Tooth Extractions In Australia and New Zealand:

A Review of Current Practice’ and Participant Information Sheet

PARTICIPANT INFORMATION FOR QUT RESEARCH PROJECT

Consent for Third Molar Tooth Extractions in Australia and New Zealand: A Review of Current Practice

QUT Ethics Approval Number 1500001114

RESEARCH TEAM Principal Researcher: Emma Badenoch-Jones Masters Student Associate Researcher: Dr Daniela Loessner Supervisor Institute of Health and Biomedical Innovation (IHBI) Queensland University of Technology (QUT) DESCRIPTION This project is being undertaken as part of a Masters study for Emma Badenoch-Jones. The purpose of this project is to look at the risks of wisdom tooth removal that patients would like to know about. All full members of the Australian and New Zealand Association of Oral and Maxillofacial Surgeons are invited to participate in this project. PARTICIPATION Participation will involve completing an eight (8) item anonymous survey asking you which risks of third molar tooth extraction you routinely include in your written consent. It will take approximately 20 minutes of your time. The following is an example of a section of one of the elements of the survey: Technical complications Damage to adjacent tooth/teeth Yes No Bone fracture (general warning) Yes No Your participation in this project is entirely voluntary. If you agree to participate you do not have to complete any question(s) you are uncomfortable answering. Your decision to participate or not participate will in no way impact upon your current or future relationship with QUT. If you do agree to participate you will not be able to withdraw from the project once you have submitted the online survey. Your responses cannot be identified. EXPECTED BENEFITS It is expected that this project will not directly benefit you. If you would like feedback on the outcomes of the survey, please contact the principle investigator Dr Emma Badenoch-Jones at [email protected]. Feedback will be provided within 6 months of completion of the survey. RISKS There are no risks beyond normal day-to-day living associated with your participation in this project. The survey is being conducted using Survey Monkey which is based in the United States of America. Information you provide on this survey will be transferred to Survey Monkey's server in the United States of America. By completing this survey, you agree to this transfer.

PRIVACY AND CONFIDENTIALITY All comments and responses are anonymous and will be treated confidentially unless required by law. The names of individual persons are not required in any of the responses. Any data collected as part of this project will be stored securely as per QUT’s Management of research data policy. Please note that non-identifiable data from this project may be used as comparative data in future projects or stored on an open access database for secondary analysis. CONSENT TO PARTICIPATE Submitting the completed online survey is accepted as an indication of your consent to participate in this project. QUESTIONS / FURTHER INFORMATION ABOUT THE PROJECT If you have any questions or require further information please contact one of the researchers listed below. Emma Badenoch-Jones [email protected] Daniela Loessner [email protected] +61 7 3138 6441 CONCERNS / COMPLAINTS REGARDING THE CONDUCT OF THE PROJECT QUT is committed to research integrity and the ethical conduct of research projects. However, if you do have any concerns or complaints about the ethical conduct of the project you may contact the QUT Research Ethics Advisory Team on +61 7 3138 5123 or email [email protected]. The QUT Research Ethics Advisory Team is not connected with the research project and can facilitate a resolution to your concern in an impartial manner.

THANK YOU FOR HELPING WITH THIS RESEARCH PROJECT. PLEASE KEEP/PRINT THIS SHEET FOR YOUR INFORMATION.

Number of years (full time equivalent) practicing as a qualified Oral and Maxillofacial Surgeon in Australia or overseas:_____________ Do you currently perform third molar tooth extractions as part of your practice? Y/N Do you ever gain informed consent (verbal and/or written) for third molar tooth extractions? Y/N If yes, in approximately what percentage of cases of third molar extractions do you gain informed consent (written and/or verbal)? ____________________________________________________ Do you routinely include the following complications of third molar extraction in your written consent? Vascular, infective and neurological complications Yes No Excessive bleeding not requiring additional surgery (general warning)

Haemorrhage requiring additional surgery

Alveolar osteitis

Local infection of the extraction site not alveolar osteitis

Deep fascial space infection

Nerve injury

Temporary inferior alveolar nerve injury Permanent inferior alveolar nerve injury Temporary lingual nerve injury Permanent lingual nerve injury Temporary nerve injury other than inferior alveolar/lingual nerve injury - including buccal nerve injury, mylohyoid nerve injury

Permanent nerve injury other than inferior alveolar/lingual nerve injury - including buccal nerve injury, mylohyoid nerve injury

Technical complications Yes No Damage to adjacent tooth/teeth

Bone fracture (general warning) Specific warning Fracture of the alveolus

Maxillary tuberosity fracture Mandibular jaw fracture

Displacement of teeth or roots (general warning) Specific warning Into the maxillary sinus

Into fascial spaces

Into the inferior alveolar nerve canal

Incomplete tooth/root removal

Wound dehiscence

Periodontal defects

Unexpected soft tissue injury including lip or tongue laceration

Bony sequestra

Complications related to adjacent structures Yes No

Oro-antral communication and/or fistula

Oro-nasal communication and/or fistula

TMJ complications (any)

Aspiration or ingestion (any, including tooth, tooth fragment, other

material or instrument)

Subcutaneous or tissue space emphysema

Are there any complications of third molar extraction not listed above that you routinely include in your written consent?

Yes

Please list:_______________________________________________________________________

No

For any of the complications of third molar extraction do you warn the patient that the complication could be life

threatening?

Y/N

Appendices 66

Appendix 2

‘Survey About Risks of Wisdom Tooth Removal’ and Participant Information Sheet

16/10/2017 Version #7

PARTICIPANT INFORMATION FOR QUT RESEARCH PROJECT – Survey –

Survey about risks of wisdom tooth removal

QUT Ethics Approval Number 1500000528 RESEARCH TEAM Principal Researcher: Emma Badenoch-Jones QUT Masters Student Associate Researchers: Dr Daniela Loessner Institute of Health & Biomedical Innovation

and Faculty of Health Adj/Prof Anthony Lynham Science and Engineering Faculty Queensland University of Technology (QUT) DESCRIPTION This project is being undertaken as part of a Masters study for Emma Badenoch-Jones. The purpose of this project is to look at the risks of wisdom tooth removal that patients would like to know about. You are invited to participate in this project because you are considering or undergoing removal of one or more of your wisdom teeth. PARTICIPATION Participation will involve completing an anonymous survey that will take approximately 20 minutes of your time. The survey will ask you about what information you would want to receive from a dentist or doctor if you were considering wisdom tooth removal. This will include what risks of wisdom tooth removal you would want to be informed of, and how information about these risks might influence how you feel about undergoing the procedure, eg would a lot of information make you feel anxious. Your participation in this project is entirely voluntary. Your decision to participate or not participate will in no way impact upon your current or future relationship with QUT (for example your grades). If you do agree to participate you can withdraw from the project without comment or penalty. However as the survey is anonymous once it has been submitted it will not be possible to withdraw. EXPECTED BENEFITS There are no risks associated with your participation in this project beyond normal day to day living. A single chocolate bar will be provided to thank you for your participation. The project results will be used in research aimed at developing a consent form for wisdom tooth extractions. RISKS There are no risks associated with your participation in this project beyond normal day to day living.

PRIVACY AND CONFIDENTIALITY All comments and responses are anonymous and will be treated confidentially unless required by law. The names of individual persons are not required in any of the responses. Any data collected as part of this project will be stored securely as per QUT’s Management of research data policy. Please note that non-identifiable data collected in this project may be used as comparative data in future projects or stored on an open access database for secondary analysis. CONSENT TO PARTICIPATE The return of the completed survey is accepted as an indication of your consent to participate in this project. QUESTIONS / FURTHER INFORMATION ABOUT THE PROJECT If you have any questions or require further information please contact one of the listed researchers: Emma Badenoch-Jones [email protected] Daniela Loessner [email protected] 3138 6441 CONCERNS / COMPLAINTS REGARDING THE CONDUCT OF THE PROJECT QUT is committed to research integrity and the ethical conduct of research projects. However, if you do have any concerns or complaints about the ethical conduct of the project you may contact the QUT Research Ethics Advisory Team on 3138 5123 or email [email protected]. The QUT Research Ethics Advisory Team is not connected with the research project and can facilitate a resolution to your concern in an impartial manner.

THANK YOU FOR HELPING WITH THIS RESEARCH PROJECT. PLEASE KEEP THIS SHEET FOR YOUR INFORMATION.

ETH_EXTRACTIONS_Survey_v5_Master_13/10/2017

Survey About Risks of Wisdom Tooth Removal This survey is for research purposes only. The aim of this survey is to gather information on what risks of wisdom tooth removal people would like to know about if they were considering undergoing the procedure. This survey only considers the risks associated with wisdom tooth removal and does not consider the risks associated with a local or general anaesthetic. The survey also does not consider the benefits associated with wisdom tooth removal. Age: ______________________ years Gender: Male Female Other Public patient Private patient 1. How much information would you like to have about wisdom tooth removal before making a decision

about whether to have that treatment?

Basic information Moderate amount of information Extensive information

2. Many of the risks of wisdom tooth removal are rare. If your dentist or doctor provides information

about these rare risks (such as the nature of the risk, its consequences and the likelihood of it occurring), would this cause you to feel very anxious about the procedure?

Yes No Unsure

3. If your dentist or doctor provides information about rare risks of wisdom tooth removal, would this

deter you from having your teeth removed?

Yes No Unsure

4. Please fill out the following table to let us know which risks of wisdom tooth removal you would like to

know about. We have explained each risk but if you don’t understand it or would like more information please ask the dentist or doctor who will perform your wisdom tooth removal. For many of the risks of wisdom tooth removal there is no accurate information available about how often the complication occurs. We have provided an indication to guide you.

Common: More than 1 in 100 Uncommon: Less than 1 in 100 and more than 1 in 1000 Rare: Less than 1 in 1000


Risk of Wisdom Tooth removal Explanation

Would you want to be warned about this risk?

Yes No

Not Understood

Dry socket A painful condition of the extraction socket that occurs because the blood clot (clump of blood) is lost from the socket too early -Common (about 1 in 8)

Bony sequestra A small piece of dead bone can appear through your gum sometime after the procedure. It doesn’t usually cause much trouble. -Common

Gum defects After you have completely healed from your wisdom tooth removal, there can be a defect of the gum where the tooth was removed. This is usually an unusual shape of the gum or a pocket in the gum. -Uncommon

Splitting open of wound

Your dentist or doctor may place stitches in your mouth after wisdom tooth removal to help close to wound. The wound may split open, often this happens because of an infection, or if the stitches are lost. -Uncommon

Excessive bleeding

During or after wisdom tooth removal the area where the tooth has been removed can bleed a lot more than normal -Common (about 1 in 33)

Excessive bleeding where you need further treatment

If you bleed a lot more than normal (as above) you may require further treatment to stop the bleeding -Uncommon

Infection An infection could develop after wisdom tooth removal -Common (about 1 in 40)

Deep infection

An infection that develops after wisdom tooth removal can spread deep into your face or neck and cause your face or neck to swell up. -Uncommon You can feel very sick and sometimes the swelling makes it hard for you to breathe. Some patients need to be treated in hospital if this happens.




Yes No

Not Understood

Damage to nearby tooth/ teeth

There can be damage to other teeth that are close to the wisdom tooth. This often happens if nearby teeth are weak due to large fillings or holes. -Uncommon (about 1 in 286)

Incomplete tooth/root removal

Sometimes your dentist or doctor is unable to remove the entire wisdom tooth. This is usually a small piece of the root of the tooth. -Uncommon for a specialist. Happens more often for a general dentist.

Temporary numbness of your lip

Wisdom tooth removal may cause some temporary nerve damage that you would notice as a numb lower lip on the side where the wisdom tooth is removed. It will take a number of months to go away. -Common (about 1 in 26)

Permanent numbness of your lip

The numb lower lip described above can be permanent in some cases -Uncommon

Numbness of your tongue or change to taste that is temporary

Wisdom tooth removal may cause some temporary nerve damage that you would notice as numbness of your tongue or change to taste on the side where your wisdom tooth is removed. It will take a number of months to go away. -Common (about 1 in 56)

Numbness of your tongue or change to taste that is permanent

The numb tongue or change to taste described above can be permanent in some cases -Uncommon or rare

Ongoing pain from nerve damage

If you have nerve damage in a rare case you could experience ongoing pain that may be hard to treat -Rare

Break in the bone (bone fracture)

Wisdom tooth removal can cause a small or big break in your upper or lower jaw bone -Rare for bottom wisdom tooth, uncommon for top wisdom tooth

Break of the part of the jaw bone that holds

A specific warning that wisdom tooth removal can cause a break of a section of your jaw that holds the root of your wisdom tooth (or roots of multiple teeth) in place.




Yes No

Not Understood

the roots of your teeth in place

This can happen on the top or bottom.

-Rare

Break of the jaw bone behind your top wisdom tooth

A specific warning that removal of your top wisdom tooth can cause the bone that sits behind it to break.

-Uncommon (about 1 in 167)

Break all the way through your lower jaw

A specific warning that lower wisdom tooth removal can cause a large break all the way through your bottom jaw during or after the procedure. After lower wisdom tooth removal the jaw bone is thin in that area and a break can happen if you chew hard on food or if there is a lot of force to your lower jaw (such as when playing sports).

-Rare (about 1 in 20,000)

Tooth or root pushed into an area of the face around the mouth

The wisdom tooth (or part of it) can be pushed into the tissues of the face that surround the mouth

-Uncommon

Tooth or root pushed into the maxillary sinus

There is an air pocket in your top jaw called your maxillary sinus. This air pocket drains into your nose and gets congested when you get sick. The roots of your top wisdom tooth can be close to the maxillary sinus and the tooth (or part of it) can be pushed into the sinus. You would then need a procedure to remove it from the sinus.

-Uncommon

Hole into maxillary sinus

If the roots of the top wisdom tooth are close to the maxillary sinus (described above) there can be a hole into the sinus after the tooth is removed. You will then need a procedure to fix the hole and this procedure is often done at the same time as your wisdom tooth removal.

-Uncommon (about 1 in 775)

Death Death is an unlikely outcome of any surgery and extremely rare for wisdom tooth removal. Would you like to be advised of this risk prior to having the surgery done?

CONSENT FOR THIRD MOLAR TOOTH EXTRACTIONS...Emma Badenoch-Jones MBBS, BDSc Submitted in fulfilment...

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Transcript of CONSENT FOR THIRD MOLAR TOOTH EXTRACTIONS...Emma Badenoch-Jones MBBS, BDSc Submitted in fulfilment...