More than Primary Stability - Straumann · of the new Bone Level Tapered Implant (BLT) implants are...

More than Primary Stability The New Tapered Standard

Bone Level Tapered Implant Introduction

Need immediate restoration of their esthetics, function and self-

confidence.

Want simpler, more cost-effective and less time-consuming dental

treatment.

Need to offer immediate implant and restorative solutions for patients

using more efficient procedures and products.

Want less invasive procedures for patients:

One stage procedures

Improved primary stability in soft bone or extraction sockets

Why Bone Level Tapered Implants?

3

Patients

Clinicians

4

55-60%

40-45%

2012 2013 2014 2015 2016 2017 2018 2019 2020

APAC LATAM NA EUParallel-walled Tapered

Global implant market by

implant design (in units)1

Anticipated growth of the tapered

implant segment until 2020 by region

Current Trend

1 Source: Millennium Report Dental Implants & Final Abutments 2014 and 2015 (actual 2013 or part of 2014).

5 Source: iData Report Dental Implants & Final Abutments Europe 2013

After 2014, more tapered implants are expected to be sold in Europe, when

compared to parallel-walled implants.

units sold

1,000,000

1,200,000

1,400,000

1,600,000

1,800,000

2,000,000

2,200,000

2,400,000

2,600,000

2,800,000

2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019

Parallel-Wall Tapered

Current Trend

6 1 European Markets for Dental Implants, Final Abutment and Computer Guided Surgery, 2013

2 Millennium Report, US MARKETS FOR DENTAL IMPLANTS 2013

Tapered 54%

Parallel 46%

Tapered 85%

Parallel 15%

EU1 USA2

By 2020, the tapered design implant will dominate the global markets

Current Trend

Estimated % share by

implant design in 2020

Straumann® Dental Implant System

7

8

Straumann® Bone Level Tapered Implant

9

Simplified handling,

legacy of Bone Level

system

Same prosthetic

portfolio for BL and

BLT

BLT is designed with clinically proven features

Allows optimized

crestal bone

preservation and

soft tissue stability

Reducing

invasiveness

with smaller

implants

Designed to maximize treatment success and predictability

Bone Control DesignTM CrossFit® connection

SLActive® Roxolid®

Bone Level Tapered Implant Product Information

The Bone Level Portfolio

Parallel implant body Full corono-apical position flexibility

Apically tapered Simplifies placement in underprepared sites

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BL BLT

12

Features and Benefits

Proven Bone Level Implant features

Broader surgical treatment options

Bone Control DesignTM

Apically tapered implant body

Proven material and surface

CrossFit® connection

SLActive®

Roxolid®

NEW!

Pleasing esthetic results

Consistent Emergence ProfilesTM

13

Allows optimized crestal bone preservation and soft tissue

stability

Bone Control DesignTM

14

Easier handling and confidence in component positioning

CrossFit® connection

15

Reducing invasiveness with smaller implants

Roxolid®

V

1Norm ASTM F67 (states min. tensile strength of annealed titanium). 2Data on file for Straumann cold-worked titanium and Roxolid® Implants

Steinemann S.G. „Titanium – the materials of choice?‟ Periodontology 2000, Vol. 17, 1998, 7-21; 12

Roxolid® shows a 20% higher tensile strength than

Straumann cold worked titanium and a 80% higher

strength than standard titanium Grade 4.

16

Allows fast and predictable osseointegration

SLActive®

Lang NP, Salvi GE, Huynh-Ba G, Ivanovski S, Donos N, Bosshardt DD.: Early osseointegration to hydrophilic and hydrophobic implant surfaces in humans. Clin

Oral Implants Res. 2011 Apr;22(4):349-56

Raghavendra S, Wood MC, Taylor TD. Int. J. Oral Maxillofac. Implants. 2005 May–Jun;20(3):425–31.

The SLActive® surface shows a faster integration into new bone

after 4 weeks (50 %) compared to the SLA® surface (30 %).

17

Optimizes and simplifies the soft tissue management

process

Consistent Emergence ProfilesTM

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Designed for excellent primary stability in challenging

clinical situations such as:

soft bone

extraction sockets

anatomical limitations

Apically tapered implant body

Full-depth threads and 3

cutting notches

Soft Bone

Tapered implants offer improved primary stability in an underprepared

osteotomy by adequate compression of the soft bone.

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20

Mimic shape of root facilitating placement in extraction sockets

Immediate engaging of bone in apical part

Extraction Sockets

21

Limited anatomy

Facial undercuts

Narrow interdental spaces

Protects anatomical structures

Nerves

Sinus

Convergent root tips

Anatomical Limitations

Radiograph shown courtesy of Dr Bob Miller, USA

Bone Level Tapered Implant Technical Specifications

Straumann® Bone Level Implants Straumann® Bone Level Tapered Implants

Parallel design Body Design Apically tapered

Roxolid®, Ti Grade IV Material Roxolid®, Ti Grade IV

SLActive®, SLA® Surface SLActive®, SLA®

Ø 3.3, 4.1 , 4.8 mm Diameter Ø 3.3, 4.1 , 4.8 mm

8, 10, 12, 14 mm Length 8, 10, 12, 14, 16 mm

twisted, parallel Drills straight flanks,

apically tapered

Optional tap Drill protocol

flexibility

according to bone

density

yes Guided Surgery no

yes Osteotome no

Overview

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Surgical flexibility

Apex

Ø 4.1 mm / 10 mm Ø 4.1 mm / 16 mm

Bone Level

Design

Apex

5 mm

4-9 mm

Corono-apical position

flexibility due to parallel wall

design in upper part

Fully-threaded and self-cutting

apex for immediate

engagement in osteotomy

Round tip to protect

anatomical structures

Lean instrument set due to only

one apex shape for all implant

lengths

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Parallel body and tapered apex

8 10 12 14 16 0.8 mm

9°

20°

Due to the tapered apex, the surface

area is reduced by 6-9% (depending

on diameter and length) compared to

full parallel walled implant (BL)

Tapered apex 5mm

Thread pitch 0.8 mm

Flank lead 20°

Apical taper: 9°

5 mm*

* On the 8mm implant the apex is 4mm to maintain minimal wall thickness around the cross-fit connection

26

Implant and drill diameters

Ø 1.4 mm

Ø 3.3 mm

Ø 2.0 mm

Ø 2.8 mm

Ø 2.7 mm

Ø 3.5 mm

Ø 3.2 mm

Ø 2.1 mm Ø 2.8 mm

Ø 2.2 mm

Ø 4.1 mm Ø 4.8 mm

STRAUMANN 04 March 2015

BLT instruments S

HO

RT

D

RIL

LS

3

3 m

m

LO

NG

D

RIL

LS

4

1 m

m

LO

NG

PR

OF

ILE

DR

ILLS

33 m

m

TA

PS

25 m

m

27

SH

OR

T P

RO

FIL

E D

RIL

LS

2

5 m

m


Compatibility

BLT BL BLT BL BLT BL new old

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BL instruments are not compatible with BLT

implants, please use dedicated drill set only.

29

The Straumann® Surgical

Cassette has been updated to

integrate the BLT instruments.

This allows flexibility, simple-

to-follow surgical workflows

and ease of use.

“One system, one surgical kit, all indications”

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Straumann® Surgical Cassette – BLT instruments


Drills

31

• 2 lengths: Short 33mm, Long 41mm

• 4 diameters: Ø2.2, 2.8, 3.5, 4.2mm

• Depth markings from 4 - 16mm

• Color coding – 2 ring

• Straight flanks

• Tapered tip

4 mm

10 mm

16 mm


Profile Drills

• 2 lengths: Short 25mm, Long 33mm

• 3 diameters : Ø 3.5, 4.1, 4.8mm


6 mm

32


Taps

• Length: 25mm

• 3 diameters : Ø 3.5, 4.1, 4.8 mm


• Tapered apex

33

16 mm

1 mm

12 mm

14 mm

• 5 diameters: Ø 2.2, 2.8, 2.2/2.8, 3.5, 4.2 mm

• Additional Ø 2.8 mm gauge

• Depth markings 4 - 16mm

• Tapered tip


Ø 2.2 Ø 2.8 Ø 2.2/2.8 Ø 3.5 Ø 4.2

Alignment Pins and Depth Gauges

34

35 Refer to brochure 490.038 Basic information for Surgical procedures for Straumann Bone Level Tapered Implant

for more information.

Single- and multi-unit

replacements: screw- or

cemented-retained

Edentulous treatment:

fixed or removable options

Cost-effective and

premium: conventional or

digital workflow

Prosthetic components

Bone Level Tapered Implant Surgical Procedure

36

37

Surgical Planning

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In multiple tooth gaps

Surgical Planning

Drilling Protocols

Example shown for Bone Level Tapered implant Ø 4.1 mm, length 12 mm 39

Type I Very hard bone : e.g. “Healed posterior mandibular site”

Full preparation of osteotomy

Same procedure as for parallel-walled Bone Level Implant

Ø 4.1 mm,

40

Flexible protocol depending on bone class


Type IV Very Soft Bone : e.g. “Full edentulous immediacy case”

Under preparation of osteotomy

Condense bone along full length of implant

Ø 4.1 mm,

Ø 4.1 mm,

41


Soft Bone with dense cortex : e.g. “Anterior extraction sockets ”

Full preparation of osteotomy in cortical part

Under preparation of osteotomy in apical part only

Condense bone in apical part only

Ø 4.1 mm,

42

Soft Bone with dense cortex : e.g. Anterior extraction sockets

Full preparation of osteotomy in cortical part.

Under preparation of osteotomy in apical part only

Condense bone in apical part only


43

15 rpm

44 Example of Bone Level Tapered implant Ø 4.1 mm / length 12 mm

Implant bed preparation Round bur Twist drills, Depth gauge and alignment pins

Profile Drill Tap

45

LoximTM Transfer Piece

Ideally, in the esthetic region, the implant shoulder should

be positioned about 3 – 4 mm subgingival of the

prospective gingival margin. The round markings in the

Loxim™ Transfer Piece indicate the distance to the

implant shoulder in 1mm steps.

46 Also available with handpiece adaptor.

Prosthetic components shown here are the Straumann Screw-retained abutments

Implant Placement

Orientation of prosthetic connection

for angled abutments

Use the Ratchet Adaptor,

Ratchet and holding key (

shown here ) in clockwise

direction no faster than 15rpm

47 Refer to 152.810 BASIC INFORMATION ON THE prosthetic procedures – Bone Level Implants

Insertion Torque

NO specific insertion torque for all situations

Range is determined by technical factors

80 Ncm is the pre-defined breaking-point of the LoximTM

transfer piece

Prevent damage of the implant‟s inner configuration

48

Insertion Torque

Flexible surgical procedure to achieve preferred torque range

If 35 Ncm is used before the implant has reached its final position,

check if the implant bed preparation is correct to avoid over-

compression of bone.

Bone Level Tapered Implant Scientific Evidence

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50

Bone Level SLActive® Implants

Clinical studies show excellent

performance in different clinical

indications and patient

conditions

Scientific Reviews

See scientific summary “Bone Level SLActive® Implants” – 490.009

51

Roxolid® SLActive® Implants

Material and surface of these

implants are scientifically proven

and widely documented.

Scientific Reviews

See scientific summary “Roxolid SLActive Implants” 490.008

52

Pre-clinical Studies

Pre-clinical Study I : A comparative study in a minipig model

Status: Completed

Hypothesis: BLT implant and the BL implant systems

show similar bone response concerning alveolar ridge

bone remodelling and osseointegration.

PI: David Cochran (USA) & Andreas Stavropoulos (SE)

Test System: 12x Göttingen Minipig, adult female

24 BL Implants / 24 BLT Implants

Model:

Intra-oral mandible model – hard bone

partly edentulous (P2-M1)

group 1: immediate loaded (8weeks)

group 2: submerged healing (4weeks)

Note: internal and preliminary data, final evaluation still ongoing, publication expected Q2 2015

53 Note: internal and preliminary data, final evaluation still ongoing, publication expected Q2 2015

Pre-clinical Studies

Pre-clinical Study I : A comparative study in a minipig model

Preliminary conclusion:

Initial placement stability,

marginal bone maintenance and osseointegration

of the new Bone Level Tapered Implant (BLT) implants

are consistent with current Bone Level implant standards

(BL).

No significant difference in mean values was found

between the 2 groups under immediate loaded and

unloaded conditions.

Publication expected for Q2 2015 Standardized radiograph after

8 weeks of loading. BL (left)

and BLT (right)

“PI/Country 6 sites, USA

Indication Open (in agreement with IfU)

Implant Roxolid BLT SLActive

Study Design Non-Interventional

Study population 90 patients

Primary Endpoint Implant success & survival

Secondary Endpoints ISQ, bone level changes, AEs

Follow Ups 1Year

Status started

Publication expected by mid 2016

Key Clinical Studies

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Non-interventional study

PI/Country Cochran/Martin, USA

Indication Single tooth


Study Design Immediate placement/

early loading

Study population 50 patients

Primary Endpoint Crestal bone level changes

1Y post loading

Secondary Endpoints Implant success & survival,

Follow Ups 1Year

Status initiated, start in Q1 2015

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Multi-Center Study USA

PI/Country Sailer, CH

Indication Single tooth


Study Design Immediate vs. conv. placement

Study population 2 x 25

Primary Endpoint TBD

Secondary Endpoints Implant success & survival,

Follow Ups 1 Year

Status initiated, start in Q1 2015

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Multi-Center Study CH

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“With the BLT system I appreciate the precise Instruments, the

great retention even in defect situations and the very good

primary stability” Dr. Bruno Schmid, CH

“As a primary stability implant, it offers advantages in cases of

immediate loading, both single and multiple implants, immediate

and early surgical protocols and type 4 bone where primary

stability may be compromised” Dr. David Furze, UK

“With BLT I feel a real benefit in terms of achievable primary

stability and insertion in narrow ridges” Dr. Paulo Casentini, IT

“Straumann® Bone Level Tapered Implant is a revolutionary

product like no others” Dr. Jean-Louis Zadikian, FR

Testimonials from controlled case series

International Headquarters

Institut Straumann AG

Peter Merian-Weg 12

CH-4002 Basel, Switzerland

Phone +41(0)61 965 11 11

Fax +41(0)61 965 10 01

www.straumann.com

More than Primary Stability - Straumann · of the new Bone Level Tapered Implant (BLT) implants are...

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