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FOR INTERNAL REFERENCE ONLY

Converting OsseoSpeed TX hold out accounts to OsseoSpeed EV

Presenters: Anders Holmén – Senior Advisor

Alfred Semaan – SoCal RM

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Converting OsseoSpeed TX hold out accounts to OsseoSpeed EV

This course is designed for the DM who is facing challenges in converting TX customers over to EV. Conversion of TX to EV is a predictable and successful process, when we manage and overcome resistance and obstacles these hold out accounts may have. Dr. Anders Holmén, one of the ”patriarchs” and ”founding fathers” of the ASTRA TECH Implant System, will be an active participant in this program as we define pathways to success.


Objectives ‒ Tell the story of the ASTRA TECH Implant System™ and it’s EVolution

Through Science ‒ Leverage key features and benefits:

• Surgical advantages • Restorative advantages

‒ Share these unique developments and the vision for the future


http://www.caranddriver.com/photo-gallery/2010-porsche-911-turbo-review

http://www.caranddriver.com/photo-gallery/2017-porsche-911-turboturbo-s-updates-for-the-uber-911s-official-photos-and-info

Resistance and Obstacles

• Completely New Surgical Set-up • Price • ATLANTIS Only • No Ti-Base • Guided Surgery Compatibilities • 5 Platform Connections • Larger Inventory


Needs based selling - PSS


ASTRA TECH Implant System™ EV Evolution through science

Presenter: Anders Holmén

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ASTRA TECH Implant System BioManagement Complex™

OsseoSpeed™ - more bone, more rapidly

Conical Seal Design™ - a strong and stable fit

Connective Contour™ - increased soft tissue contact zone and volume

MicroThread™ - biomechanical bone stimulation


Publication list

More than 1 600 articles in scientific journals


Clinical studies show: • No dip in implant stability quotient 1

• Good esthetics 2 and high patient satisfaction 3

• Survival rate from 94.5% – 100% including advanced protocols: • immediate loading 4

• atrophic edentulous maxilla 5

• extraction sockets 6 • sinus lifted/grafted posterior sites 7

• Majority of studies report a mean marginal bone loss of 0.3 mm or less after 1-5 years in function 8,9

1. Geckili O, et al. A 24-week prospective study comparing the stability of titanium dioxide grit-blasted dental implants with and without fluoride treatment. Int J Oral Maxillofac Implants 2009;24(4):684-88. 2. Noelken R, Neffe BA, Kunkel M, Wagner W. Maintenance of marginal bone support and soft tissue esthetics at immediately provisionalized OsseoSpeed implants placed into extraction sites: 2-year results. Clin Oral Implants Res 2013;E-pub Jan 16. 3. Erkapers M, Ekstrand K, Baer RA, Toljanic JA, Thor A. Patient satisfaction following dental implant treatment with immediate loading in the edentulous atrophic maxilla. Int J Oral Maxillofac Implants 2011;26(2):356-64. 4. Collaert B, Wijnen L, De Bruyn H. A 2-year prospective study on immediate loading with fluoride-modified implants in the edentulous mandible. Clin Oral Implants Res 2011;E-pub, Jan 18. 5. Toljanic JA, Baer RA, Ekstrand K, Thor A. Implant rehabilitation of the atrophic edentulous maxilla including immediate fixed provisional restoration without the use of bone grafting: a review of 1-year outcome data from a long-term prospective clinical trial.

Int J Oral Maxillofac Implants 2009;24(3):518-26. 6. Lops D, et al. Incidence of inter-proximal papilla between a tooth and an adjacent immediate implant placed into a fresh extraction socket: 1-year prospective study. Clin Oral Implants Res 2008;19(11):1135-40. 7. de Vicente JC, Hernandez-Vallejo G, Brana-Abascal P, Pena I. Maxillary sinus augmentation with autologous bone harvested from the lateral maxillary wall combined with bovine-derived hydroxyapatite: clinical and histologic observations. Clin Oral Implants Res 2010;21(4):430-8. 8. Schliephake H, Rodiger M, Phillips K, McGlumphy EA, Chacon GE, Larsen P. Early loading of surface modified implants in the posterior mandible - 5 year results of an open prospective non-controlled study. J Clin Periodontol 2012;39 (2):188-95. 9. Mertens C, Steveling HG. Early and immediate loading of titanium implants with fluoride-modified surfaces: results of 5-year prospective study. Clin Oral Implants Res 2011;22(12):1354-60.

ASTRA TECH Implant System™ - OsseoSpeed™ implants


but……..


Demands & Challenges

• User friendly • Immediate stability • Rapid and reliable healing • Long term predictability • Restorative flexibility • Esthetic results • Component compatibility • Mechanical durability • Cost effectiveness


Development Limitations


Evolution based on customer feedback

• Improve surgical simplicity and flexibility • Possibility to achieve higher primary stability • Restorative ease • System logics • Increased robustness • Maintain ASTRA TECH Implant System

BioManagement Complex™ intact – securing relevance of available clinical documentation

OsseoSpeed™ - more bone more rapidly



Connective contour ™ - increased soft tissue contact zone and volume


ASTRA TECH Implant System BioManagement Complex™ • OsseoSpeed™

‒ unchanged

• MicroThread™ ‒ thread design - unchanged ‒ length - harmonized

• 2.5/3.5 mm – straight implants • 4 mm – conical implants

• Conical Seal Design™ ‒ 11° tapered connection - unchanged ‒ contact zone between implant and abutment - unchanged ‒ sealing capability – unchanged

• Connective contour™ ‒ unchanged


Design philosophy

When designing an implant system, several parameters need to be considered: • long-term biological and clinical performance • ease of use and tactility • versatility and indication coverage • mechanical integrity and robustness


Design philosophy

ASTRA TECH Implant System™ EV • based on the natural dentition using a site-specific,

crown-down approach • designed to meet the requirements for mechanical

integrity, bone quantity, load carrying capacity, and biological response

• ASTRA TECH Implant System BioManagement Complex™ maintained FOR INTERNAL REFERENCE ONLY

Advisory Board

Background – solid design input

Core Reference Group

Clinical Study

Ambassador 1 Ambassador 2


Ambassador Program • 47 Ambassadors world wide • Largest program ever • Using ASTRA TECH Implant System™ EV

screw- and cement-retained • Over 800 implants and total of 4500 products

delivered

Test of system claims, features,

benefits & values


Evolution through science - ASTRA TECH Implant System™ EV

• Extensive mechanical testing • Extensive clinical testing

‒ clinical multicenter study ‒ ambassador programs


Aim: to test the mechanical strength of a further developed implant system

Materials & Methods: • test implants (OsseoSpeed EV, different diameters) and control implants

(OsseoSpeed TX, different diameters) were connected to corresponding two-component titanium abutments

• assemblies were fatigue tested according to ISO 14801:2007 (30° off-axis loading to test the strength of the implant)

Results & Conclusions: all test assemblies were between 11-20% superior in fatigue resistance compared to corresponding control assemblies in all dimensions

Mechanical testing of implants

Johansson H, Hellqvist J. Functionality of a further developed implant system. Mechanical integrity (P339). Clin Oral Implant Res 2013;24(S 9):166


Aim: to test the mechanical strength of a further developed implant system

Materials & Methods: • test abutments (TiDesign EV, Direct Abutment EV) and control abutments

(TiDesign, Direct Abutment) were connected to their corresponding implant • the assemblies were fatigue tested according to a 90° off-axis load method

developed by DENTSPLY Implants • this method better evaluates the implant abutment interface compared to the ISO

14801:2007 method, which primarily evaluates the strength of the implant itself

Results & Conclusions: the results of the fatigue tests demonstrated improved mechanical strength for the test assemblies compared to the controls

Mechanical testing of abutments


Mechanical testing of abutments

+47%

TX 3.0S EV 3.0S TX 3.5S EV 3.6S TX 4.0S EV 4.2S EV 4.2C EV 4.8S EV 4.8C EV 5.4S

Strength index

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Endurance strength for TiDesign EV connected to OsseoSpeed EV – presented as an index proportional to the strength of corresponding abutments (TiDesign) connected to OsseoSpeed TX


Aim: to prove the mechanical performance of a new abutment design

Materials & Methods: • test abutments (33⁰ Uni Abutment EV, including cylinder and bridge

screw) and control abutments (20⁰ UniAbutment) were connected to their corresponding implant

• the abutment/cylinder assemblies were fatigue tested according to a 90° off-axis load method developed by DENTSPLY Implants

Results & Conclusions: • the 33⁰ Uni Abutment EV showed superior mechanical integrity compared

to the control group

Feasibility testing of a new abutment design

Dahlström M and Hellqvist J. Feasibility testing of a new abutment design (P323). Clin Oral Implant Res 2013;24(S 9):158.


Feasibility testing of a new abutment design

Dahlström M and Hellqvist J. Feasibility testing of a new abutment design (P323). Clin Oral Implant Res 2013;24(S 9):158.


Aim: to justify an implant system where a unique abutment screw design applies to each implant size and where the same insertion torque applies for all abutments

Materials & Methods: • test (OsseoSpeed EV) and control implants (OsseoSpeed TX) and corresponding

abutments and abutment screws were evaluated • torque of the abutment screws and the resulting preload were recorded using an

Instron 55 MT torsion testing device

Optimization of preload and torsion by using a unique abutment screw design for each implant platform size

Halldin A and Dahlström M. Optimization of preload and torsion by using a unique abutment screw design for each implant platform size (P332). Clin Oral Implant Res 2013;24(S 9):162-163.


Optimization of preload and torsion by using a unique abutment screw design for each implant platform size Results & Conclusions: • at the recommended installation torque

(25 Ncm), each abutment screw design delivered the preferred minimum preload of 250 N

• the preload was higher for the test group compared to the control group

• the controlled preload promotes reduction of screw loosening, endurance to high bite forces, and absence of interface leakage

Halldin A and Dahlström M. Optimization of preload and torsion by using a unique abutment screw design for each implant platform size (P332). Clin Oral Implant Res 2013;24(S 9):162-163.


Aim: to study fluid leakage of the implant-abutment interface

Materials & Methods: • test implant/abutment assemblies (TiDesign EV/OsseoSpeed EV)

and control (TiDesign/OsseoSpeed TX) were used • a fluid leakage test was performed under cyclic loading in accordance with the ISO

14801:2007 method

Results & Conclusions: No leakage was detected for any of the test or control samples, irrespective of the degree of load. The tested implant-abutment connections can be considered a tight internal conical seal

Credibility of an up-dated implant system. Implant-abutment leakage testing

Johansson H, Hellqvist J. Credibility of an up-dated implant system. Implant-abutment leakage testing (P340). Clin Oral Implant Res 2013;24(S 9):166


Drilling procedure and insertion torque testing Drilling protocol for ASTRA TECH Implant System EV delivers a preferred degree of primary implant stability • Insertion torque values were recorded for implant installation in artificial bone

‒ OsseoSpeed EV 4.2 S; drilling protocol – thin cortical bone protocol ‒ OsseoSpeed TX 4.0 S; drilling protocol – soft bone protocol

• The results indicate the possibility to achieve a higher primary stability for OsseoSpeed EV measured as insertion torque in soft bone


Summary and Conclusion • Thorough testing has demonstrated that the ASTRA TECH Implant

System EV exceeds the predecessor in strength and reliability ‒ The OsseoSpeed EV 4.2 S implant is 17% stronger than its predecessor ‒ The OsseoSpeed EV 4.2 S abutment is 47% stronger than its predecessor ‒ Uni Abutment EV is 40% stronger than it’s predecessor ‒ Each individual abutment screw delivers controlled preload and reduced

torsion at the recommended installation torque ‒ The Conical Seal Design connection shows no micro-leakage ‒ The flexible drilling protocol delivers preferred primary stability

• All benefits and principles of the ASTRA TECH Implant System BioManagement Complex are maintained


ASTRA TECH Implant System BioManagement Complex™

OsseoSpeed™ - more bone, more rapidly


Connective Contour™ - increased soft tissue contact zone and volume



Evolution through science - ASTRA TECH Implant System™ EV

• Extensive mechanical testing • Extensive clinical testing

‒ clinical multicenter study ‒ ambassador programs


Clinical study OTX-PLUS-0001 Primary objective

• Marginal bone level alterations one year after loading between OsseoSpeed™ EV and OsseoSpeed™ TX

• 59 subjects 79 OsseoSpeed™ EV implants • 61 subjects 87 OsseoSpeed™ TX implant

To evaluate and compare:


http://mmm.astratech.com/?dept=repositoryAssetInfo&assetId=12856&topTab=328282005

http://mmm.astratech.com/?dept=repositoryAssetInfo&assetId=12856&topTab=328282005

Prospective, randomized, controlled, multicenter study comparing two versions of an implant system. Study centers: • Dr. Clark Stanford, University of Iowa, USA (International co-ordinating investigator) • Dr. Hugo De Bruyn, University of Gent, Belgium • Dr. Denis Cecchinato, Padova, Italy • Dr. Dr Hans-Christoph Lauer, Goethe University, Frankfurt, Germany • Dr. Nurit Bittner, University of Columbia, USA

Stanford C., Raes, S., Cecchinato D., Brandt J. and Bittner N. Poster presented at Academy of Osseointegration, March 6 - 8, 2014, Seattle, Washington


Prospective, randomized, controlled, multicenter study comparing two versions of an implant system. Aim: to compare marginal bone level changes, implant survival rates and surgeon’s perception of primary stability, between OsseoSpeed™ EV and OsseoSpeed™ TX Materials & Methods: • 120 partially dentate subjects (maxilla and mandible), randomized to either test

(OsseoSpeed™ EV) or control (OsseoSpeed™ TX), 60 subjects in each group • One-stage surgical protocol • Early loading, 6-8 weeks after implant placement • Cement-retained restorations • 5-year follow-up



Prospective, randomized, controlled, multicenter study comparing two versions of an implant system. Results & Conclusions: • Marginal bone level changes were small and did not differ between the groups • Insertion torque values were higher for OsseoSpeed EV • The surgeons expressed a perception of higher primary stability for OsseoSpeed EV

Courtesy of Dr. Nurit Bittner and Dr. James Fine. Columbia University, College of Dental Medicine, New York, NY.



Marginal Bone Level changes - Loading to 1 year follow-up

Frequency distribution of bone level change measured – radiographic – from time of loading to 1-year follow-up; 68% of OsseoSpeed EV implants lost no marginal bone while 32% showed minimal bone loss, less than 0.5 mm.


Surgeons’ perception - Implant has a good primary stability


1. EAO 2013: 4 technical posters 2. EAO 2013: clinical poster, 6-months data 3. AO 2014: clinical poster, 1-year data 4. AO 2014: clinical poster, data on 5.4 mm implants 5. Scientific Reviews

– OsseoSpeed, MicroThread, Conical Seal Design, Connective Contour – Marginal bone maintenance, Long-term clinical documentation

6. Evolution through science – ASTRA TECH Implant System EV To come… 7. 1-year publication 8. AO 2015: clinical poster, 2-year data

Scientific Support


Key Features and Benefits

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System overview – key points - surgical advantages

• Surgical simplicity and flexibility

‒ an intuitive, color-coded surgical tray

‒ versatile implant designs

‒ drilling protocol allows for preferred

primary stability


New dimensional options for added surgical versatility

Guided surgery concept adding confidence and predictability to

the treatment procedure

OsseoSpeed™ Profile EV - Highlights

Simple and predictable procedure with the one-position-only placement

Expanded range of restorative treatment options

Simple and accurate workflow between clinician and laboratory


Ø 3.0 mm implant

A two-piece implant solution optimal for cases with limited horizontal space in lower anteriors or upper laterals

8 mm 9 mm


Ø 5.4 mm implant

A 5.4 mm implant diameter option for treatment of the molar region

6 mm 8 mm 9 mm 11mm 13 mm 15 mm


6 mm implant length option

Ideal for cases with limited vertical bone height ‒ helps reduce the need for bone augmentation


Expanded drilling protocol - OsseoSpeed™ EV straight and conical


Flexible drilling protocol - providing the preferred primary stability

The stepped osteotomy design ensures proper preparation of the marginal bone for implant placement, while achieving the preferred level of primary stability

4.0 mm


System overview – key points - restorative advantages

• Site-specific restorative components • New unique interface design with one-

position-only placement for ATLANTIS patient-specific abutments

• Self-guiding impression components • One system – One torque


One interface – three indexing solutions

Six positions Indexed abutments seat in six available positions.

Index free Index free abutments seat in any rotational position.

One-position-only ATLANTIS patient-specific abutments seat in one position only.


Color-coding - restorative and lab components

Abutment screws

Healing components Lab components

Implant Pick-up components

Implant Transfer components


Uni Abutment EV

• Solid prosthetic interface with a M1.8mm Bridge Screw EV • Design facilitates non-parallel implant situations up to 66° • One top-cone angle (33°) for simplified inventory management


For internal use only

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