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Mercy Gray
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Converting OsseoSpeed TX hold out accounts to OsseoSpeed EV Presenters: Anders Holmén

3 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.

and benefits: Surgical advantages Restorative advantages

4 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

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

6 Needs based selling - PSS

9 ASTRA TECH Implant System BioManagement Complex OsseoSpeed - more bone, more rapidly MicroThread - biomechanical bone stimulation Conical Seal Design - a strong and stable fit Connective Contour - increased soft tissue contact zone and volume

10 Publication list More than articles in scientific journals

ASTRA TECH Implant System - OsseoSpeed implants Clinical studies show: No dip in implant stability quotient 1 Good esthetics 2 and high patient satisfaction 3 Survival rate from 94.

11 ASTRA TECH Implant System - OsseoSpeed implants 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): 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 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): 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 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): 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): 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): 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): 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):

12 but..

predictability Restorative flexibility Esthetic

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

14 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

17 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 MicroThread - biomechanical bone stimulation Conical Seal Design - a strong and stable fit Connective contour - increased soft tissue contact zone and volume

18 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

19 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

20 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

21 Background solid design input Core Reference Group Advisory Board Clinical Study Ambassador 1 Ambassador 2

cement-retained Over 800 implants and total of 4500

22 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

23 Evolution through science - ASTRA TECH Implant System EV Extensive mechanical testing Extensive clinical testing clinical multicenter study ambassador programs

Mechanical testing of implants Aim: to test the mechanical strength of a further developed implant system Materials & Methods: test implants (OsseoSpeed EV, different diameters)

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

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

Mechanical testing of abutments Aim: to test the mechanical strength of a further developed implant system Materials & Methods: test abutments (TiDesign EV, Direct

load method developed by DENTSPLY Implants this method better evaluates the implant abutment interface compared to the ISO 14801:2007 method, which primarily evaluates

25 Mechanical testing of abutments 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 Strength index 3.00 2.50 2.00 1.50 1.00 0.50 +47% 0.000 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.

26 Mechanical testing of abutments Strength index % 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 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

Feasibility testing of a new abutment design Aim: to prove the mechanical performance of a new abutment design Materials & Methods: test abutments (33⁰ Uni Abutment EV, including cylinder and bridge

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

28 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.

Optimization of preload and torsion by using a unique abutment screw design for each implant platform size Aim: to justify an implant system where a unique abutment screw design

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

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

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

the control group the controlled preload promotes reduction of screw loosening, endurance to high bite forces, and absence of interface leakage Halldin A and

30 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):

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

32 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

33 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

34 ASTRA TECH Implant System BioManagement Complex OsseoSpeed - more bone, more rapidly MicroThread - biomechanical bone stimulation Conical Seal Design - a strong and stable fit Connective Contour - increased soft tissue contact zone and volume

35 Evolution through science - ASTRA TECH Implant System EV Extensive mechanical testing Extensive clinical testing clinical multicenter study ambassador programs

36 Clinical study OTX-PLUS-0001 Primary objective To evaluate and compare: 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

37 Prospective, randomized, controlled, multicenter study comparing two versions of an implant system. Stanford C., Raes, S., Cecchinato D., Brandt J. and Bittner N. Poster presented at Academy of Osseointegration, March 6-8, 2014, Seattle, Washington 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

38 Prospective, randomized, controlled, multicenter study comparing two versions of an implant system. Stanford C., Raes, S., Cecchinato D., Brandt J. and Bittner N. Poster presented at Academy of Osseointegration, March 6-8, 2014, Seattle, Washington 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

Poster presented at Academy of Osseointegration, March 6-8, 2014, Seattle, Washington Results & Conclusions: Marginal bone level changes were small

39 Prospective, randomized, controlled, multicenter study comparing two versions of an implant system. Stanford C., Raes, S., Cecchinato D., Brandt J. and Bittner N. Poster presented at Academy of Osseointegration, March 6-8, 2014, Seattle, Washington 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.

40 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.

41 Surgeons perception - Implant has a good primary stability

42 Scientific Support 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

45 System overview key points - surgical advantages Surgical simplicity and flexibility versatile implant designs drilling protocol allows for preferred primary stability an intuitive, color-coded surgical tray

46 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 New dimensional options for added surgical versatility Guided surgery concept adding confidence and predictability to the treatment procedure

47 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

48 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

49 6 mm implant length option Ideal for cases with limited vertical bone height helps reduce the need for bone augmentation

50 Expanded drilling protocol - OsseoSpeed EV straight and conical

51 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

52 System overview key points - restorative advantages Site-specific restorative components New unique interface design with oneposition-only placement for ATLANTIS patient-specific abutments Self-guiding impression components One system One torque

53 One interface three indexing solutions One-position-only ATLANTIS patient-specific abutments seat in one position only. Six positions Indexed abutments seat in six available positions. Index free Index free abutments seat in any rotational position.

54 Color-coding - restorative and lab components Implant Pick-up components Abutment screws Healing components Implant Transfer components Lab components

55 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

56 THANK YOU For internal use only

FOR INTERNAL REFERNCE ONLY

FOR INTERNAL REFERNCE ONLY TX to EV Transition Possibilities and Challenges TX to EV Transition Why? ASTRA TECH Implant System BioManagement Complex OsseoSpeed - more bone, more rapidly MicroThread - biomechanical bone stimulation