Study of Efficacy of Titanium Three- Dimensional Locking Plate...

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Study of Efficacy of Titanium Three- Dimensional Locking Plate In The Treatment of Mandibular Fractures Pavan Kumar B 1 , Yashwanth Yadav 2 , Venkatesh V 3 , Brahmaji Rao J 4 ORIGINAL RESEARCH INDIAN JOURNAL OF DENTAL ADVANCEMENTS Journal homepage: www. nacd. in ABSTRACT: Context: Face is the window through which we perceive the world around us and the world perceive us. In the era of increasing automobilization and industrialization the treatment of mandibular fractures has attained a prominent position. The main goal in the treatment of fracture is to restore pre injury anatomical form, with associated aesthetics and function. Aim: The purpose of the study is to evaluate the efficacy of Titanium Three Dimensional Locking Plates in the treatment of mandibular fractures. Methods and Materials: Total twenty patients were selected who suffered with mandibular fractures randomly. All patients were operated through the standard intra oral incision at fracture site of the mandible and immobilized the fracture segments using titanium three dimensional locking plating systems. The resulting osteosynthesis were evaluated with the scoring system for 9 parameters and complications encountered during their use were also recorded and reported in this study Results: The results of this study suggest that fixation of mandibular fracture with 3D plates provides three-dimensional stability and carries low morbidity and infection rates. These plates functions as internal fixator achieving stability by locking the screw to the plate, the other advantages offered by them are less screw loosening, less precision in plate adaptation and less alteration of the osseous or occlusal relationship upon screw tightening. Conclusion: During the course of present study, 3D plates stabilize the bone fragments in three dimensions because of closed quadrangular geometric shape and the ease of contouring and adapting. The 3D plate was found to be standard in profile, strong yet malleable, facilitating reduction and stabilization at both the superior and inferior borders giving three-dimensional stability at fracture site. But the small sample size and limited follow up could be considered as the limitations of our study. It is hence recommended to have a multicenter study with large number of patients and correlation among these studies to authenticate our claims. Key words: Titanium Three Dimensional Locking Plate System, Mandibular Fractures, Open Reduction Internal Fixation (ORIF). doi: 10.5866/2016.8.10222 1 Professor and HOD 2 Senior Lecturer 3&4 Professor Department of Oral and Maxillofacial Surgery, Kamineni Institute of Dental Sciences, Narketpally. Article Info: Received: October 8, 2016 Review Completed: November 10, 2016 Accepted: December 11, 2016 Available Online: December, 2016 (www.nacd.in) © NAD, 2016 - All rights reserved Email for correspondence: [email protected] Quick Response Code Indian J Dent Adv 2016; 8(4): 222-231

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Study of Efficacy of Titanium Three-Dimensional Locking Plate In The

Treatment of Mandibular FracturesPavan Kumar B1, Yashwanth Yadav2, Venkatesh V3, Brahmaji Rao J4

O R I G I N A L R E S E A R C H

INDIAN JOURNAL OF DENTAL ADVANCEMENTS

Jour nal homepage: www. nacd. in

ABSTRACT:

Context: Face is the window through which we perceive the worldaround us and the world perceive us. In the era of increasingautomobilization and industrialization the treatment ofmandibular fractures has attained a prominent position. The maingoal in the treatment of fracture is to restore pre injury anatomicalform, with associated aesthetics and function.

Aim: The purpose of the study is to evaluate the efficacy ofTitanium Three Dimensional Locking Plates in the treatment ofmandibular fractures.

Methods and Materials: Total twenty patients were selected whosuffered with mandibular fractures randomly. All patients wereoperated through the standard intra oral incision at fracture siteof the mandible and immobilized the fracture segments usingtitanium three dimensional locking plating systems. The resultingosteosynthesis were evaluated with the scoring system for 9parameters and complications encountered during their use werealso recorded and reported in this study

Results: The results of this study suggest that fixation ofmandibular fracture with 3D plates provides three-dimensionalstability and carries low morbidity and infection rates. These platesfunctions as internal fixator achieving stability by locking the screwto the plate, the other advantages offered by them are less screwloosening, less precision in plate adaptation and less alteration ofthe osseous or occlusal relationship upon screw tightening.

Conclusion: During the course of present study, 3D platesstabilize the bone fragments in three dimensions because of closedquadrangular geometric shape and the ease of contouring andadapting. The 3D plate was found to be standard in profile, strongyet malleable, facilitating reduction and stabilization at both thesuperior and inferior borders giving three-dimensional stabilityat fracture site. But the small sample size and limited follow upcould be considered as the limitations of our study. It is hencerecommended to have a multicenter study with large number ofpatients and correlation among these studies to authenticate ourclaims.

Key words: Titanium Three Dimensional Locking Plate System,Mandibular Fractures, Open Reduction Internal Fixation (ORIF).

doi: 10.5866/2016.8.10222

1Professor and HOD2Senior Lecturer3&4ProfessorDepartment of Oral and Maxillofacial Surgery,Kamineni Institute of Dental Sciences, Narketpally.

Article Info:

Received: October 8, 2016Review Completed: November 10, 2016Accepted: December 11, 2016Available Online: December, 2016 (www.nacd.in)© NAD, 2016 - All rights reserved

Email for correspondence:[email protected]

Quick Response Code

Indian J Dent Adv 2016; 8(4): 222-231

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Introduction:

Fractures of the facial skeleton can be studiedand described in anatomic terms, by functionalconsiderations, by treatment strategies and byoutcome measures. Functional and morphologiccharacteristics that are unique to lower facialskeleton must be considered. The aim of mandibularfracture treatment is the restoration of anatomicalform and function, with particular care to establishthe occlusion.1 The present era of fast moving, resultoriented life has made a definite impact on thecommon man. Individuals have begun to workharder, faster and become more aggressive towardsreaching their goals. Maxillofacial trauma is verycommon in all these unforeseen events and theunique position of the mandible on the face makesit vulnerable. It is therefore, one of the mostcommonly fractured facial bones.2 Methods of openreduction and internal fixation have changed anddiversified enormously in the past few years.3 Withthe development of osteosynthesis in maxillofacialsurgery different systems have been designed. Theyhave become smaller, simpler to handle and extraoral incisions can be avoided. Miniplate fixation ofmandibular fractures has become a standard. Eventhough the idea of plate osteosynthesis is more than100 years old, more research is needed for optimaltreatment.4 When selecting a fixation scheme for afracture one has to consider many things such asthe size, number of fixation devices, their location,ease of adaptation and fixation, biomechanicalstability, the surgical approach, the amount of softtissue disruption necessary to expose the fractureand place the fixation devices. Research continuesto focus on the size, shape, number, andbiomechanics of plate/screw systems to improvesurgical outcomes. 3, 5 With the above considerations,in recent times two systems have been studiedcommonly namely 3 dimensional (3D) and thelocking miniplate with its comparison toconventional miniplates using Champy’s principle.6-

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The 3D plating system is based upon theprinciple of obtaining support through geometricallystable configuration. The quadrangle geometry of

plates assures a good stability in three dimensionsof the fracture site since it offers good resistanceagainst torque forces.6

The present study was designed with an aim ofevaluating the efficacy of 3D Titanium LockingPlates in the treatment of Mandibular Fracture andto report the complications encountered during itsuse.

Materials and Methods:

The present study consisted sample of twentypatients who reported with fractures of mandibleand were treated over a period between September2011 and August 2013. Out of twenty patients 16were male and 4 were female patients.

Criteria for case selection were Patients withfractures of the mandible between the two mentalforamina and angles of the mandible and low levelsubcondylar fractures, patients above the age of 17years, patients without significant history of medicaldisorders, patients reporting to the departmentwithin 7 days of trauma (Figure 1). The followingcases were not included in the study, patients below17years of age, medically compromised patients,gross infection at the site of fracture, more than 7days after injury. The radiographic evaluationconsisted of OPG (Figure 2), and in required casesCT-scans with 3D reconstruction were taken pre-operatively. While a post-operative OPG was takenon third day, fifteenth day, one month, two months,and three months. Post-operative OPG is plannedto assess the approximation of the fracture fragmentand to check loosening of screws and fracture of theplate.

Procedure:

An intraoral vestibular incision was givenextending to about 2 cm on either side of the fractureline. The mucoperiosteal flap was then raised andthe fracture site was exposed (Figure 3) and curettedwith the help of curette to remove granulation tissueand blood clots. The fracture site was irrigated with5% povidine iodine followed by normal saline. In themandibular angle region, a mucoperiosteal incisionwas made over the external oblique ridge. In the

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parasymphysis region, a vestibular mucosal incisionwas made obliquely through the mentalis muscle,with care taken to isolate the labial branches ofmental nerve. After adequate exposure the fracturesite, the segments were manipulated and reducedto normal anatomic position. Dental occlusion waschecked, after achieving occlusion temporary IMFwas done.

Adaptation and Fixation of Plate:

Plate was adapted to the underlying bone butit does not require the kind of adaptation requiredin conventional plate. Care was taken to center thehole on the plate and hole made perpendicular tobone surface. The 3 Dimensional locking plates wereadapted across the fracture site (Figure 4). The screwholes were made with 1.5mm drill bit, perpendicularto the surface of bone under copious saline irrigation.Plates were fixed with 2 × 10 mm titanium lockingscrews.

Following reduction, 2.0 mm 3 Dimensionaltitanium locking miniplates were placed along theosteosynthesis line as described by Champy. Duringdrilling, the adapted plate was held firmly againstthe bone with the plate holding forceps. The patientswere evaluated pre-operatively, immediate postoperatively, 15days, 1month, 2months, and 3monthspostoperatively. Each parameter was evaluated withthe help of a scoring system on every visit of thepatient. The parameters were – Operating time,Occlusion (Figure 5), Need for the post-operativeIMF, Infection, Mobility of fracture segment, Pain,Wound dehiscence, Neurological deficit, ImplantFailure.

Grading Systems:

1. Operating time taken: In all the cases totaloperating time was recorded after intubation andGA i.e. the infiltration of local anaesthesia at thesite of surgery till the last suture was placed. Forour study the time taken from adaptation of the plateto the time when the last screw placed in mandibularfracture site region was recorded.

2. Occlusion scale.

a. 1 –No occlusal disturbances

b. 2 –Minor occlusal disturbances

c. 3 -Severe occlusal disturbances

3. Infection scale

a. 0 – Absent

b. 1 – Present

4. Pain assessment scale

a. 0 - No pain

b. 1 –Mild pain

c. 2 –Moderate pain

d. 3 –Severe pain

5. Mobility of fracture fragments (scale)

a. 0 – Absent

b. 1 – Present

6. Soft tissue dehiscence scale

a. 0 – Absent

b. 1 – Present

7. Neurological deficit scale

a. 0 - Absent

b. 1- Present

8. Implant failure

a. 0- Absent

b. 1- Present

Results:

A total of twenty patients were included in thestudy, out of which 16 were male and 4 were femalepatients. Incidence of mandibular fractures wasmore in males (80%) compared to females. This maybe justified by the fact that the males are generallymore prone to situations in which there are highrisk of trauma. In this study Parasymphysis wasthe most common site of fracture involving in 11(55%) cases, followed by Symphysis 6 (30%), Angle4 (20%) and Body 3 (15%) of mandible.

Average operating time for the adaptation andplacement of each type of plate at mandibularfracture site region was noted in minutes. The total

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operating time required for the completion of eithermultiple or isolated surgical procedures ranged from45 minutes to 120 minutes with a mean of 68.45minutes and the duration of plate adaptation andfixation ranged from 4 minutes to 10 minutes witha mean of 5.95 minutes. The mean time of theoperating isolated fractures was found to be 55.15minutes, and 93.14 minutes to treat multiplefractures. The mean time taken for plate fixationwas 4.46 minutes for isolated fractures and 8.71minutes for multiple fractures. Occlusion of thepatient was evaluated preoperatively andpostoperatively at 1 week, 1 month, 2 months andat 3 months. Infection is the most commoncomplication of surgical intervention. The patientswere evaluated for signs of infection. The potentialpossibility for infection is always a considerationwhen treating mandibular fractures, especiallywhen there is communication with oral cavity.Manifestations of infection include pain, mobilityof fracture segment, plate loosening, sinus tract withpus discharge, wound. Preoperatively patients withgross infection at the site of fracture were excludedfrom the study. Postoperatively signs of infectionwere checked after one week, one month, two monthsand three months. Pain was recorded based on thevisual analogue scale for patients preoperatively andpost operatively on one week, two weeks, one month,two months, three months, at mandibular fracturesite. Scores for assessment of pain as follows, 0 - Nopain, 1 –Mild pain, 2 – Moderate pain, 3 - Severepain.

Discussion:

Face is the window through which we perceivethe world around us and the world perceive us. Inthe era of increasing automobilization andindustrialization the treatment of mandibularfractures has attained a prominent position. Themain goal in the treatment of fracture is to restorepre injury anatomical form, with associatedaesthetics and function. The goal must beaccomplished by means that will produce the leastdisability, risk and shortest recovery period for thepatient.11

The treatment of mandibular fractures has

evolved over a period of time from old methods ofbandaging and splinting, which are forms of closedreduction, to the more recent methods of openreduction.1 General acceptance of openosteosynthesis did not appear in maxillofacialliterature, until an organized research was done bythe AO group in 1950.3 Even in open osteosynthesistechnique there had been a metamorphosis andchange in trends from rigid fixation in 1968, to semi-rigid fixation in 1973.12 Rigid fixation using dynamiccompression plate had its own disadvantages suchas need of very wide incision, bulky nature of platesand the procedure itself which was techniquesensitive.13 Michelet (1973) ended the search forsimple osteosynthesis that would guarantee fracturehealing without compression.14 This was modified,developed and put to practical use by Champy in1978.15 Fixation using such plates simplified surgeryand reduced surgical morbidity, however, they failedto surpass the predictability of rigid fixation using2.4 mm compression and reconstruction plates.12

Farmand developed the concept of 3Dminiplates. Their shape is based in the principle ofquadrangle as a geometrically stable configurationfor support.6 Since, the stability achieved by thegeometric shape of these plates surpasses thestandard miniplates. The basic form is quadrangularwith 2 × 2 holed square plates and 3 × 2 (or) 2 × 2rectangular plate. 3D miniplates holds the fracturesegments rigidly by resisting the 3D forces namelyshearing, bending and torsional forces occurring onthe fracture site in function. The present studyshowed that the 3D plate allows no movement atthe superior and inferior borders with maximaltorsional and bending forces as opposed to a singlelinear plate applied to superior border area. Strutplates may therefore provide greater resistanceagainst gap opening at the inferior border withbiting forces compared to a single plated applied atthe external oblique ridge or superior lateralborder.12

In osteosynthesis minimum of implant materialwith maximum stability should always beconsidered. The three dimensional titanium platesfulfill this requirement ideally. Due to closed

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Figure 1: Right and left occlusal view showing fracture of the mandible between the two mental foramina.

Figure 2: Pre-operative OPG of the patient showingsymphysis fracture of mandible.

Figure 3: Incision and exposure of the fracture

Figure 4: Placement of the 3 D locking miniplates Figure 5: Right and left occlusal view showing occlusion postoperatively.

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quadrangular geometric configuration of the plates,less foreign material is needed to stabilize thefragments.16

The purpose of the present study was toevaluate the efficacy of Titanium Three DimensionalLocking Plates in the treatment of mandibularfractures. Objectives were to evaluate the efficacyof - Titanium Three Dimensional Locking Plates, tostudy the technique of the procedure, to evaluateand assess, occlusal stability, biomechanicalstability of the fractured fragments post operatively,Ease of plate adaptation for ORIF of mandibularfractures, complications encountered, Duration ofthe procedure, Any need for post-operative IMF(Intermaxillary fixation). The time required for thesurgery, adaptation and fixation of the plate at thefracture site was recorded for all the patients. Thetotal operating time required for the completion ofeither multiple or isolated surgical proceduresranged from 45 minutes to 120 minutes with a meanof 68.45 minutes and the duration of plateadaptation and fixation ranged from 4 minutes to10 minutes with a mean of 5.95 minutes. The meantime of the operating isolated fractures was foundto be 55.15 minutes, and 93.14 minutes to treatmultiple fractures. The mean time taken for platefixation was 4.46 minutes for isolated fractures and8.71 minutes for multiple fractures.

FELEDY et al and ZIX et al reported a reducedaverage operating time of 55 minutes, single fracturesite, in our study similar results are noticed(54.5minutes).8, 17

3D plate is geometrically configured plate whichconsists of two horizontal bars interconnected withvertical bars. So single 3D plate stabilized thefracture both at superior and inferior border at atime, Hence, time is saved in plate fixation. But, incases of oblique fracture or the fracture runningthrough the mental foramina, more time wasrequired for the placement of 3D plate. In such cases,the plate was placed either inferior or superior tothe foramina, and care taken while placing the platesuperior to the foramina, so that the screws areplaced between the roots of the teeth. Easyapplication and simplified adaptation to the bone,

as well as simultaneous stabilization at both thesuperior and inferior border makes the 3D plate atime-saving alternative to conventional miniplates.

Restoration of pre-morbid occlusion is one of themost important goals of the management offractures in dentofacial region. The effect of notrestoring the occlusion to its original condition isdisabling and can cause severe effects especially onthe temporo -mandibular joint.

In the present study, occlusal disturbances ofthe patients was assessed preoperatively andpostoperatively and was graded as, minor, severeor no disturbance. There were minor occlusaldisturbance in six cases, at premolar region andsevere occlusal disturbance in 14 casespreoperatively. Among the six cases of minorocclusal disturbance, we achieved normal premolarand molar relationship in two patients. In fourpatients guiding elastics (blue) were used and theocclusal disturbance persisted even on the 15th

postoperative day, which was gradually correctedand occlusion was stabilized by the end of 1st monthpostoperatively.

Out of 14 severe occlusal discrepancy cases,stable occlusion was achieved in 13 patients and onlyone case showed occlusal discrepancy, whichpersisted even during the 3rd postoperative month.

The above results were elicited by using 3DTitanium locking plate fixation with a thoroughfollow up of 3 months post operatively, indicatingthat, 3D Titanium locking plates have a major rolein achieving a stable post-operative occlusion.

Occlusal discrepancy was seen because of,imbalance between the muscular activity of themuscles of mastication, after trauma and due toedema in TMJ region. However 4 cases requiredpostoperative MMF due to condylar fractures, whichwere not treated by ORIF owing to theundisplacement.

Out of twenty patients, 16 patients did notrequired MMF postoperatively, because we wereable to achieve ideal premolar and molar occlusion.Whereas, four cases required postoperative MMF

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due to condylar fractures along with the Symphysisand Parasymphysis which were treated successfullyby giving guiding elastics (blue color) for a period of1week and following by MMF using wire for next 2weeks. Mandibular fractures are often contaminatedby oral bacteria. The propensity of infection isincreased in the cases where the lingual mucosa islacerated and reluctance on part of the patient toswallow or move his tongue freely so that, stasisdevelops with consequent accumulation of debris inthe region of fracture. This causes multiplication ofbacteria resulting in delayed union. In addition tothis a delay in immobilization will to contaminationwhich further leads to delayed union. Stability isconsidered as the best protection against infection,as movement in the presence of foreign bodies (i.e.loose screws) usually leads to infection andmalunion. Infection rate is also shown to be less withintra-oral approach.18 Avascularity is a risk factor,which should be given primary consideration andthe presence of teeth in the line of fracture areothers.

In the present study, patients were evaluatedpreoperatively and postoperatively at 2 weeks, 4weeks, 2 months and 3 months, for the signs ofinfection. Pain, swelling, local rise in temperature,local inflammation and pus discharge wereconsidered as indicators for the presence of infection.Out of twenty cases there was only one case ofpostoperative infection patient reported to our OPDwith a severe through and through laceration ofright side of the face exposing F-Z region, RightZygoma region and Left Angle region. Due to theextent of severity of the laceration it was decided topost the case in emergency and all sites werereduced. A 3D plate was used to reduce the fracturein Left Angle region and soft tissue closure wasperformed. Patient had numbness in the areasupplied by Infra Orbital Nerve but had noParesthesia of Mental Nerve. The infection in thiscase might be due to improper preparation, lack ofpre-operative antibiotic infusion, impropersterilization of armamentarium or failure tomaintain aseptic condition in the operation theatre.Patient was asymptomatic when discharged fromthe hospital, but came back with pain, swelling and

opening of sutures after a week of the surgery. Onexamination, intraorally it was seen that there wasmild wound dehiscence, pus discharge, raise intemperature, halitosis and exposure of the plate inLeft Angle region. He was kept under antibioticcover and regular oral irrigation with betadinesolution. Wound closure was done using 3-0 vicryl.Patient was recalled after a week, but he did notturn up for review. Wound dehiscence was againnoticed after a month. Infection did not subsidewhich lead to the failure and subsequent removalof the implant.

With open reduction and internal fixation, thereported incidence of infection ranged from 3% to32%. Guimond et al, reported an infection rate of5.4% (2 out of 37 patients) with the use of 3D plates.9

Feledy et al, reported 9% infection rate (2 out of 22patients) and Zix et al, reported 0% (0 out of 20)infection rate in their study.8, 17 In the present studyinfection rate reported was 5% using 3D lockingplate. It had been claimed that mobility of fracturedsegments is a causative factor in post-operativeinfections. Because infection is the most commoncomplication in mandibular fractures, theimprovement of plate stability might be a way tominimize this problem. Guimond et al alsoexperienced, low incidence of wound dehiscence andplate exposure with 3D plates in comparison toChampy’s miniplate.9

Mandible is the site associated with a relativelyhigh incidence of altered fracture healing (malunion,non-union). There are a number of specific riskfactors associated with mandibular fractures andtheir potential for non-union or malunion. Infectionis the contributing risk factor to unfavorable healingand mobility. Other risk factors include poorapposition of fracture segments, presence of foreignbodies, unfavorable muscle pull on the fracturesegments, displacement of comminuted fracturesegments (and the difficulty associated withadequately reducing them), aseptic necrosis of bonyfragments, soft tissue interposition, malnutritionand debilitation. The most common cause of failure(non-union) is, residual mobility across the fracturesite. Movements of the bone ends will disrupt the

Study of Efficacy of Titanium Three-Dimensional Locking Plate Pavan Kumar B, et, al.

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fibro vascular structures, decrease the recruitmentof osteoprogenitor cells and allow for fibrous tissueingrowth instead of bony healing. Other contributorsto fracture non-union include impaired healingcapacity secondary to illness, tobacco use andinfection. In some instances, there may be loss ofbone, producing a continuity defect, which willrequire bone graft reconstruction.19

Mobility at the fractured site was examined in20 patients preoperatively, at various follow upstages. In our study, all patients had mobility (100%)of fracture fragment. It was observed that 1 case(5%) out of 20 cases had mobility after 3D Titaniumlocking plate fixation in 2nd postoperative week. Bythe 1st postoperative month 19 (95%) out of 20patients showed no mobility in fractured segments,except one patient (5%) who showed mobility at thefracture site. At 6th week infected plate was removedand inter dental wiring was done to reduce themobility in that patient. At the end of 2nd

postoperative month no mobility was noticed in 19patients. But, mild mobility was seen in 1 patient.Wiring was removed at 2nd month when the infectionwas subsided and fracture mobility was also absent.At the end of 3rd postoperative month mobility wasnot present in any of the patients.

Rigidity of fractured segments produces a stablefoundation for soft tissue growth provides improvedvascularity to the area and allows better healing ofwound. It also prevents bacteria from beingcontinually pumped through the fracture site,Thereby, decreasing the chance of osteitis. It is seenthat greater the mobility, greater the chance ofinfection. Initially, a multidisciplinary experimentwas carried out by a group of engineers to check outthe rigidity of monocortical plate fixation. Althoughthis system is semi-rigid, the amount of rigiditydemonstrated is sufficient for effectiveosteosynthesis of fractures and to resist masticatoryforces during the period of healing. Recently AlperAlkan et al, carried out an in-vitro study to evaluatethe biomechanical behavior of four different typesof rigid fixation systems with semi-rigid fixationsystem that are in use currently.20 The studydemonstrated that 3D struts plates had greater

resistance to compression loads than the Champy’stechnique.

Pain associated with the procedure wasrecorded for all the patients based on a visualanalogue scale preoperatively and post operativelyat one week, two weeks, one month, two months,three months, at mandibular fracture sites. Scoresfor assessment of pain as follows, o- no pain, 1- Mildpain, 2- Moderate pain, and 3- Severe pain. Thepreoperative pain score was moderate (grade 2) intwo patients and in 18 patients the pain was severe(grade 3).The overall average preoperative painscore was 100%. On the 1st post operative day painwas higher due to more swelling at the operated side.At the end of 1 week pain was mild (grade 1) in 12patients, moderate (grade 2) in 4 patients and severe(grade 3) in 4 patients. At the end of 2 weeks painwas decreased in 18 patients (mild), moderate in 1patient and severe in 1 patient. At the end of 1 monthpain was absent in 18 patients and one patient hadmoderate pain (grade 2) and another one withpersisted severe pain (grade 3) which came tomoderate at the end of 6th week after removal ofinfected 3D Titanium locking plate. At the end of 2months 19 patients elicited no pain and pain wasmoderate in one patient. At the end of 3rd post-operative month there was no pain in all thepatients.

In the present study the patients were alsochecked for wound dehiscence at the site of fracture,on the immediate post-operative day, after 2 weeks,1month, 2months, and 3 months. In our study outof 20 patients, 18 patients showed excellentpostoperative healing, all of them were totallyasymptomatic, and the soft tissue over the site washealthy.

In one case the sutures were opened and thewound dehiscence was seen on 1st weekpostoperatively. Patient was reviewed periodicallyevery alternative day, wound was thoroughlyirrigated with saline and betadine and sutures wereplaced again, kept on antibiotics and continuousfollow up was done, which led to satisfactorysecondary healing. It was observed that by the endof 2 month healing was satisfactory.

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But in another case there was wounddehiscence observed 1st week postoperatively andeven after repeated follow ups the wound healingdid not improved, infection continued to persist evenafter 1month, 2month post operatively resulting infailure of the implant by the end of 3 month.

Neurological deficit of all the 20 patients wasassessed pre and postoperatively, out of 20 casesparesthesia was seen in six patients pre operativelywho was diagnosed with Parasymphysis fractures,paresthesia continued postoperatively in fourpatients which did not subside by end of 1 month,in all these six cases intraoperatively it was foundthat the mental nerve was intact in four cases andthe nerve was entrapped in two cases in all thesecases careful dissection carried out, mental nervewas isolated and preserved, plate fixation was done.Paresthesia might be there due to swelling followedby operative procedure and retraction of the nerveduring plate fixation.

Two patients elicited nerve regeneration by theend of 2 months and by the end of 3 months theremaining two patients showed complete nerveregeneration. All the cases are well appreciated tohealthy functioning.

Implant Failure includes loosening of screwsand breakage of the plate which was assessed in allthe 20 patients post operatively both clinically andradiographically on 1st postoperative day, at 2 weeks,4weeks, 2 month and 3 month interval. Among the20 patients, 19 patients showed no implant failure,whereas in one case loosening of the screws wasdocumented. Farmand M reported a good stabilityagainst traction forces and torsional forces with 3Dplating system.6 Wittenberg et al also reported that3D plating system may provide adequate fixationfor mandibular fractures.8 In light of the evidenceprovided by the literature, in our study all the casesfracture fragments were found to be stable afterplate fixation and no inter fragmentary mobility wasobserved, thus ascertaining that 3D plate wassuperior in respect of stability.

Conclusion:

The present study concludes that 3D plates

stabilize the bone fragments in three dimensionsbecause of closed quadrangular geometric shape, andthe ease of contouring and adapting. Due to betterinterfragmentary stability, supplemental fixation inthe form of IMF/MMF is not necessary, therebyenhancing the overall comfort, convenience andwellbeing of the patients. 3D plate holds the fracturesegments rigidly by resisting the 3D forces namelyshearing, bending and torsional forces occurring onthe fracture site in function. Our clinical results andbiomechanical investigations have shown a goodstability of the 3D plates in the osteosynthesis ofmandibular fractures without major complications.The thin connecting arms of the plate allow easyadaptation to the bone without distortion. The freeareas between the arms permit good blood supplyto the bone. The 3D plate allows no movement atthe superior and inferior borders with maximaltorsional and bending forces as opposed to a singlelinear plate applied to superior border area. Whenone linear plate is placed at the superior border area,torsional and bending forces usually cause themovement along the axis of the plate withbuccolingual splaying and gap formation at theinferior borders, respectively. All the patients in ourstudy appreciated early recovery of normal jawfunction, uneventful healing and good union at thefracture site with minimal weight loss due to earlyreinstatement of the masticatory function. Therewas great patient acceptance of this treatmentmodality. 3D plates were indeed easy and simple touse. Significant reduction in operating time couldbe achieved with the use of 3D plates which makesit a time-saving alternative to conventionalminiplates. Placement of 3D plate was found to bemore comfortable to the surgeon. The 3D plate wasfound to be standard in profile, strong yet malleable,facilitating reduction and stabilization at both thesuperior and inferior borders giving three-dimensional stability at fracture site. The smallsample size and short duration of follow up could beconsidered as the limitations of our study. It is hencerecommended to have a multicenter study with largenumber of patients and correlation among thesestudies to authenticate our claims.

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Indian J Dent Adv 2016; 8(4): 222-231

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Study of Efficacy of Titanium Three-Dimensional Locking Plate Pavan Kumar B, et, al.

Indian J Dent Adv 2016; 8(4): 222-231