Clinical Research High-Lights: All-on-4™ December 2011 336_Library_Scientific Support All on Four High-Lights_Feb 2012

What is an All-on-4™ solution? Four implants in edentulous jaws, providing a secure and optimal support for an implant bridge (even with minimum bone volume) Clinical solution maximizing the use of available bone by tilting the posterior implants up to a maximum of 45º Efficient treatment procedure Immediate loading

All-on-4™ benefits Benefits of angled posterior implants: Help avoid relevant anatomical structures and can be anchored in better quality anterior bone Offer improved support of the prosthesis by reducing cantilevers Reduce the need for bone grafting by maximizing the use of available bone Final restoration: Full-arch restoration with only 4 implants Fixed and removable final prosthetic solutions Flexible solutions Efficient treatment flow: Immediately loaded for shorter treatment times and improved patient satisfaction Implant placement accuracy: All-on-4 Guide assists with accurate placement of implants Can be combined with computer-aided diagnostics and treatment concept NobelGuide

Why All-on-4™? Treatment option for edentulous patients and soon-to-be edentulous Very efficient treatment Allow the patient to immediately have teeth Reduce the need for bone grafting High aesthetics and function High hygiene maintenance capability Reduced cost for the patient High profit for the professional Simple surgical and prosthetic procedure to allow more dentists to perform it

Efficient treatment with All-on-4™ Guide & NobelSpeedy™ implant 44-year old edentulous female patient requests a fixed restoration due to inadequate function, comfort and esthetics of the existing removable denture. Case courtesy of Dr. Paulo Maló, DDS, MaloClinic Lisbon, Portugal Diagnosis Limited bone volume in the posterior and a need for bone crest level optimization. Implant site preparation Implant site preparation according to the drilling protocol for parallel walled implants using the All- on-4 Guide. The vertical lines on the guide are used as reference for drilling at an angle of 45°. Preparation A conventional flap procedure is performed, the bone crest level optimized and the All-on-4 Guide anchored. Implant insertion Insertion of NobelSpeedy Groovy implants with external hex connection. Case courtesy of Dr. Paulo Maló, DDS, MaloClinic Lisbon, Portugal Case courtesy of Dr. Paulo Maló, DDS, MaloClinic Lisbon, Portugal Provisional prosthesis Immediate loading of the implants can be achieved by using a fixed provisional prosthesis based on an impression taken straight after surgery.

All-on-4™: Clinical data Materials 17 centers / 1283 patients / 5267 implants / 0.5 - 10 years follow-up Components NobelActive, Brånemark System TiUnite implants, NobelSpeedy Groovy and Brånemark System MK III Groovy implants Results CSR short term2,6,7,10,11 (0.5 - 1 year) 97.6% - 100% CSR mid-term7,8 (3 - 4 years) 96,9% - 100% CSR mid-term8,9 (4 - 5 years) 99.73% - 98.36% CSR long-term13,14 (5 - 10 years) 94.80% - 98.0% High CSR in both edentulous mandible and maxilla1-11, also with NobelGuide.4 Favorable marginal bone levels2,7,9,12 and soft tissue parameters.3,6,8 Long-term viable option – up to 10 years follow-up in the mandible13 and 5 years in the maxilla.14 Evidence-based, predictable, cost-effective, graftless solution for full arch rehabilitations. 1. Malò P et al. CIDRR 2003 6. Francetti L et al. CIDRR 2008 10. Agliardi E et al. Quintessence Int 2010 14. Malo P et al. CIDRR 2011 2. Malo P et al. CIDRR 2005 7. Francetti L et al. JOMI 2009 11. Babbush C et al. 2010 (poster IADR Barcelona) 3. Malo P et al. CIDRR 2006 8. Pomares C. Eur J Oral Impl 2009 12. Francetti L et al. CIDRR 2010 4/5. Malo P et al. JPD 2007 (2 papers) 9. Agliardi E et al. COIR 2010 13. Malo P et al. J Am Dent Ass 2011

All-on-4™: Key studies Reference: Malo P, de Araújo Nobre M, Lopes A. Clin Implant Dent Relat Res 2011 [Epub ahead of print] All-on-4 immediate function concept for completely edentulous maxillae: a clinical report on the medium (3 years) and long term (5 years) outcomes. Objective/Results: This retrospective study included 242 patients with a total of 968 immediate loading implants (four per patient), all placed in the upper anterior region, to support fixed full-arch maxillary prostheses. The inclusion criterion was having an edentulous maxilla, or a maxilla with hopeless teeth, in need of fixed implant restorations. A total of 19 implants failed in 17 patients, giving cumulative patient-related and implant-related survival rates of 93.0 percent and 98.0 percent, respectively, at 5 years of follow-up. The prostheses' survival rate was 100.0 percent. Conclusion: The high survival rates at patient and implant level indicates that the immediate loading concept for completely edentulous maxillae using the All-on-4 protocol is viable in the medium and long term outcomes.

All-on-4™: Key studies Reference: Malo P, de Araújo Nobre M, Lopes A, Moss SM, Molina GJ. J Am Dent Assoc 2011;142(3):310-20 A longitudinal study of the survival of All-on-4 implants in the mandible with up to 10 years of follow-up. Objective/Results: This longitudinal study included 245 patients with a total of 980 immediate loading implants (four per patient), all placed in the anterior region, to support fixed full-arch mandibular prostheses. The inclusion criterion was having an edentulous mandible, or a mandible with hopeless teeth, in need of fixed implant restorations. A total of 21 implants failed in 13 patients, giving cumulative patient-related and implant-related success rates of 94.8 percent and 98.1 percent, respectively, at five years, and 93.8 percent and 94.8 percent, respectively, with up to 10 years of follow-up. The prostheses' survival rate was 99.2 percent with up to 10 years of follow-up. Conclusion: The results support the conclusion that use of the All-on-4 immediate loading implant concept in completely edentulous mandibles is viable in the long term.

All-on-4™: Key studies Reference: Agliardi E, Panigatti S, Clericò M, Villa C, Malò P. Clin Oral Implants Res 2010;21(5):459-65 Immediate rehabilitation of the edentulous jaws with full fixed prosthesis supported by four implants. Interim results of a 5-year single cohort (173 patients) prospective study. Objective/Results: The purpose of the study was to prospectively evaluate clinical and radiological clinical and radiological outcomes of immediately loaded full-arch fixed prosthesis supported by a combination of axially and non-axially positioned implants in a large cohort of patients with completely edentulous jaws, up to 5 years of function. Cumulative implant survival rate at one year was 98.26% and 99.75% for the maxilla and the mandible respectively. Marginal bone loss averaged 0.9+-0.7 mm in the maxilla and 1.2+-0.9 mm in the mandible. No difference was found in marginal bone loss between axial and tilted implants. Conclusion: The present preliminary results from a relatively large sample size suggests that the present technique can be considered a viable treatment option for the immediate rehabilitation of both mandible and maxilla.

All-on-4™: Key studies Reference: Agliardi E, Francetti L, Romeo D, Del Fabbro M. Int J Oral Maxillofac Implants 2009;24(5):887-95 Immediate rehabilitation of the edentulous maxilla: preliminary results of a single-cohort prospective study. Objective/Results: The purpose of the study was to prospectively evaluate a new surgical protocol for the immediate rehabilitation of edentulous maxilla without using bone grafting. A total of 120 implants (30 BS and 90 NobelSpeedy Groovy) were inserted/immediately loaded and clinically and radiologically followed up to between 18 and 42 months (average 27.2). No implants failed. All prosthesis were stable and in function. At 1 year mean marginal bone loss around axial and tilted implants was similar: 0.8 mm for axial (SD 0.4, N =30) and 0.9 for tilted implants (SD 0.5 mm, n=60) (P> .05) Plaque and bleeding scores decreased over time, patient satisfaction with both aesthetics and function increased. Conclusion: This technique can be considered a viable treatment modality for the immediate rehabilitation of the edentulous maxilla, as it provides optimal support in the posterior region, minimizes distal cantilevers and avoids bone grafting or sinus augmentation.

Pomares C. Eur J Oral Implantol 2009;2(1):55 - 60 All-on-4™: Key studies Reference: Pomares C. Eur J Oral Implantol 2009;2(1):55 - 60 A retrospective clinical study of edentulous patients rehabilitated according to the “All on Four” or the all on six immediate function concept. Objective/Results: The aim of the study was to assess the clinical results of an implant placement protocol using 4 or 6 implants supporting immediately loaded fixed prosthesis in both mandible and maxilla. The cumulative implant survival rate at 3-4 years follow-up was 96.9%. No prosthesis failed. Conclusion: The results indicate that the All on Four and all on six immediate loading concept could be an effective and predictable treatment for the rehabilitation of the edentulous mandible and maxilla.

All-on-4™: Key studies Reference: Francetti L, Agliardi E, Testori T et al. Clin Implant Dent Relat Res 2008;10(4):255-63 Immediate rehabilitation of the mandible with fixed full prosthesis supported by axial and tilted implants: interim results of a single cohort prospective study. Objective/Results: The aims of the study were to assess the treatment outcome of immediately loaded full-arch bridges anchored to both tilted and axially placed implants for the rehabilitation of the mandible and to compare the outcome of axial versus tilted implants. Cumulative implant survival and prosthesis success rate was 100% at 1 year follow-up. No significant difference in marginal bone loss was found between tilted and axial implants. Conclusion: The data suggest that immediate loading associated with tilted implants could be considered a viable treatment modality for the mandible.

All-on-4™: Key studies Reference: Francetti L, Romeo D, Corbella S et al. Clin Implant Dent Relat Res 2010 Oct 26 [Epub ahead of print] Bone level changes around axial and tilted implants in full arch fixed immediate restorations. Interim results of a prospective study. Objective/Results: The aims of the study were to assess clinical outcome and peri-implant bone level changes around tilted and axial implants supporting full-arch fixed immediate restorations (All-on- Four) up to 60 months of loading. Forty-seven patients were scheduled for follow-up at 6,12, 18, 24 months and annually up to 5 years (mean follow-up was 52.8 and 33.8 in the mandible and maxilla respectively). No implant was lost. No significant difference in marginal bone loss was found between axial and tilted implants in both jaws, at each follow-up. No significant difference in bone loss was found between mandible and maxilla, for both axial and tilted implants at each comparable timeframe, although slightly higher mean values were always found for the mandible. Conclusion: The use of tilted implants in the immediate rehabilitation of edentulous jaws is safe and is not associated to a higher marginal bone loss as compared to axially placed implants.

All-on-4™: NobelActive™ Reference: Babbush C, Kutsko G, Brokloff J. Clear Choice Dental Implant Center, Pepper Pike, OH. Poster presentation: Saturday, July 17, 2010: 3:30 p.m. - 4:45 p.m. Location: Exhibit Hall (CCIB) The All-on-Four immediate function treatment concept with the NobelActive implants. Objectives/Methods: This single center retrospective study evaluated the concept when utilizing an implant with a tapered body and a variable thread design. 708 NobelActive restoring both jaws (109 maxillae / 68 mandibles), 165 subjects included. 12 subjects were treated in both jaws. Implant follow- up occurred up to 23 months. Each subject received two axial and two distally tilted implants. Implants were placed in healed and/or fresh extraction sites. Each subject received an immediately loaded, fixed complete-arch provisional prosthesis according to the All-on-Four concept. The definitive prosthesis was delivered within 6 months of implant insertion. An actuarial life table method was used to determine implant survival rate. Fisher's exact test was used to determine the level of significance comparing the survival rates of the arches. Results: 436 implants placed in mandible / 272 in maxilla. 3 implants failed in maxilla (replaced successfully). The failures occurred 1, 4 and 7 months post-operative. The overall survival rate was 99.5% (6 months) with no significant difference between the maxillae / mandibles (99.3% vs. 100%, p = 0.06, Fisher's exact test). No total arch failures have occurred (definitive prosthesis survival rate of 100%). Conclusion: Preliminary survival rate using the All-on-Four immediate loading treatment concept with above-mentioned implant can be considered a viable treatment concept for subjects presenting edentulous arches and/or immediate placement. Supported by Nobel Biocare

All-on-4™: Main publications 2008-2011 Francetti L, Agliardi E, Testori T, Romeo D, Taschieri S, Fabbro MD. Immediate rehabilitation of the mandible with fixed full prosthesis supported by axial and tilted implants: interim results of a single cohort prospective study. Clin Implant Dent Relat Res 2008 Apr.1. Agliardi E, Francetti L, Romeo D, Taschieri S, Del Fabbro M. Immediate loading in the fully edentulous maxilla without bone grafting: the V-II-V technique. Minerva Stomatol 2008; 57(5):251-9 Bellini CM, Romeo D, Galbusera F, Taschieri S, Raimondi MT, Zampelis A, Francetti L. Comparison of tilted versus non tilted implant-supported prosthetic designs for the restoration of the edentulous mandible: a biomechanical study. Int J Oral Maxillofac Implants 2009;24 (3):511-7 Bellini CM, Romeo D, Galbusera F, Agliardi E, Pietrabissa R, Zampelis A, Francetti L. A finite element analysis of tilted versus non tilted implant configurations in the edentulous maxilla. Int J Prosthodont 2009; 22 (2):155-7

All-on-4™: Main publications 2008-2011 Pomares Puig C. Retrospective clinical study of edentulous patients rehabilitated according to the All on Four or the All on six immediate function concept. Eur J of Oral Implantol 2009;2(2):115-124 Agliardi EL, Francetti L, Romeo D, Del Fabbro M. Immediate rehabilitation of the edentulous maxilla: preliminary results of a single-cohort prospective study. Int J Oral Maxillofac Implants 2009;24(5):887-95 Agliardi E, Panigatti S, Clericò M, Villa C, Malò P. Immediate rehabilitation of the edentulous jaws with full fixed prostheses supported by four implants. Interim results of a 5-year single cohort prospective study. Clin Oral Implants Res 2010;21(5): 459- 65 Agliardi E, Clericò M, Ciancio P, Massironi D. Immediate loading of full arch-fixed prosthesis supported by axial and tilted implants for the treatment of edentulous atrophic mandible. Quintessence Int 2010;41(4):285-93 Francetti L, Romeo D, Corbella S, Taschieri S, Del Fabbro M. Bone level changes around axial and tilted implants in full arch fixed immediate restorations. Interim results of a prospective study. Clin Implant Dent Relat Res 2010 Oct 26 [Epub ahead of print] Weinstein R, Agliardi E, Fabbro MD, Romeo D, Francetti L. Immediate Rehabilitation of the extremely atrophic mandible with fixed full- prosthesis supported by four implants. Clin Implant Dent Relat Res 2010 Feb 11 [Epub ahead of print]

All-on-4™: Main publications 2008-2011 Pomares Puig C. A retrospective clinical study of edentulous patients rehabilitated according to the “all on four” or the “all on six” immediate function concept and flapless computer-guided implant surgery. Accepted for publication on Eur J of Oral Implantology Malo P, de Araújo Nobre M, Lopes A, Moss SM, Molina GJ. A longitudinal study of the survival of All-on-4 implants in the mandible with up to 10 years of follow-up. J Am Dent Assoc 2011;142(3):310-20. Malo P, de Araújo Nobre M, Lopes A et al. All-on-4 Immediate function concept for completely edentulous maxillae: a clinical report on th emedium (3 years) and long term (5 years) outcomes. Clin Implant Dent Relat Res 2011 [Epub ahead of print]