Replace Facts & Figures

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1 Replace Facts & Figures Clinical studies on Replace Select Tapered and Straight Implants (June 2005) The Replace implants are available with a straight and a tapered body, and with two different surfaces: TiUnite and HA. The documentation referred to below consists of articles and abstracts published, or accepted for publication, in scientific journals. TiUnite surface The TiUnite surface was introduced on the market in the year It has proven to support the healing process and to better preserve implant stability during healing in both experimental and clinical studies Numerous studies have evaluated the clinical performance of TiUnite implants. The studies, mostly performed with a single-stage surgery and early or immediate loading, show high implant success rates (96-100%) Four-year data have recently been published, demonstrating good long-term results for TiUnite implants 26. HA-surface The HA-coated surface has been documented in long-term studies including more than 3600 implants placed in about 1400 patients followed for 5 years after prosthetic loading. The results show high cumulative implant success rates, between 95 and 98% Published articles with short-term results (1-2 years) on the HA-coated implants, used in single-stage surgery and early or immediate function, show the same high implant success rates Histological evaluations of retrieved HA-coated implants in humans show that the Replace HA-coating is not prone to resorption or dissolution in contact with bone tissue Tapered and straight implant body designs The Replace Select implant with a tapered design was introduced on the market in 1997 and has been documented in several clinical studies 45-50, In most of these studies, single-stage surgery and immediate function were applied, and the implants were often placed directly into extraction sockets The results show high cumulative implant success rates, between 97 and 100 %, after 1 year of prosthetic loading. The Replace Select straight implants have the same body design as the Brånemark System implants. This implant design is extensively documented in the many long-term (up to 20 years follow-up), prospective clinical studies performed over the last decades References 1 Albrektsson T, Johansson C, Lundgren AK, Sul Y, Gottlow J. Experimental studies on oxidized implants. A histomorphometrical and biomechanical analysis. Appl Osseointegration Res 2000;1:21-24

2 2 Carr AB, Knobloch L, Larsen PE, Keller J. Comparison of machined and roughened surface implants loaded at 2, 4, and 6 weeks. IADR Abstract J Dent Res 2001;80. Special issue 3 Da Silva D, Sennerby L, Hockers T, Lundgren AK, Gottlow J, Rompen E. Time-related bone response after insertion of machined/tiunite Brånemark implants: a dog study. Abstract 4. Clinical Oral Implants Research 2001:12:393 4 Degidi M, Petrone G, Iezzi G, Piattelli A. Histologic evaluation of a human immediately loaded titanium implant with a porous anodized surface. Clin Implant Dent Relat Res 2002;4: Glauser R, Schüpbach, Lundgren AK, Gottlow J, Hämmerle CHF. Machined and oxidized microimplants retrieved from humans: a comparison using histomorphometry and micro-computed tomography. EAO Abstract 64. Clin Oral Implants Res 2002;13(4):xxxv 6 Gottlow J, Henry P, Tan A, Allan B, Johansson C, Hall J. Biomechanical and histologic evaluation of the TiUnite and Osseotite implant surfaces in dogs. Appl Osseointegration Res 2000;1: Gottlow J, Johansson C, Albrektsson T, Lundgren AK. Biomechanical and histologic evaluation of the TiUnite and Osseotite implant surfaces in rabbits after 6 weeks of healing. Appl Osseointegration Res 2000;1: Henry P, Tan A, Allan B, Hall J, Johansson C. Removal torque comparison of TiUnite and turned implants in the Greyhound dog mandible. Appl Osseointegration Res 2000;1: Huang Y-H, Xiropaidis AV, Sorensen RG, Albandar JM, Hall J, Wikesjö UME. Bone formation at titanium porous oxide (TiUnite ) oral implants in type IV bone. Clin Oral Impl Res 2005;16: Ivanoff C-J, Widmark G, Johansson C, Wennerberg A. Histological evaluation of the bone response to oxidized and turned titanium micro implants in human jawbone. Int J Oral Maxillofac Implants 2003;3: Rocci A, Martignoni M, Sennerby L, Gottlow J. Immediate loading of a Brånemark System implant with the TiUnite surface: Histological evaluation after 9 months. Appl Osseointegration Res 2002;3: Rocci A, Martignoni M, Burgos P, Gottlow J, Sennerby L. Histology of retrieved immediately and early loaded oxidized implants. Light microscopic observations after 5 to 9 months of loading in the posterior mandible of 5 cases. Clin Implant Dent Relat Res 2003; 12 (suppl 1): Rompen E, DaSilva D, Lundgren AK, Gottlow J, Sennerby L. Stability measurements of a double-threaded titanium implant design with turned or oxidized surfaces. An experimental resonance frequency analysis study in the dog mandible. Appl Osseointegration Res 2000;1: Salata LA, Rasmusson L, Novaes AB, Papalexiou V, Sennerby L. The influence of anodic oxidation on implant integration and stability in bone defects. An RFA study in the dog mandible. Appl Osseointegration Res 2002;3: Schüpbach P, Glauser R, Lundgren AK, Gottlow J, Hämmerle CHF. Evaluation of the bone tissue around implants by a new microtomographic technique. IADR Abstract Cardiff J Dent Res Divisional abstracts issue 2003;82 16 Sennerby L, Miyamoto I. Insertion torque and RFA analysis of TiUnite and SLA implants. A study in rabbit. Appl Osseointegration Res 2000; 1: Xiropaidis A V, Qahash, W H Lim, R H Shanaman, R G Sorensen, J M Wozney, U M Wikesjö, J Hall. Bone-implant contact at calcium phosphate and titanium porous oxide (TiUnite ) modified dental implants. IADR Abstract. J Dent Res, Spec iss A 2002;81. p 489. # Zechner W, Tangl S, Fürst G, Tepper G, Thams U, Mailath G, Watzek G. Osseous healing characteristics of three different implant types. A histologic and histomorphometric study in mini-pigs. Clin Oral Implants Res 2003; 14: Zechner W, Tangl S, Tepper G, Fürst G, Bernhart T, Haas R, Mailath G, Watzek G. Influence of platelet-rich plasma on osseous healing of dental implants: A histologic and histomorphometric study in minipigs. Int J Oral Maxillofac Implants 2003; 18: Calandriello R, Tomatis M, Vallone R, Rangert B, Gottlow J. Immediate occlusal loading of single lower molars using Brånemark System Wide Platform TiUnite implants: An interim report of a prospective, open-ended clinical multicenter study. Clin Implant Dent Relat Res 2003;5 (suppl 1): Calandriello R, Tomatis M, Rangert B, Gottlow J. Immediate function of tilted implants in the atrophic posterior maxilla. Clin Oral Impl Res 2004;15(4), Abstract Friberg B, Billström C. Preliminary results of a prospective multicenter clinical study on TiUnite implants. Appl Osseointegration Res 2002;3: Glauser R, Portmann M, Ruhstaller P, Lundgren AK, Hämmerle C, Gottlow J. Stability measurements of immediately loaded machined and oxidized implants in the posterior maxilla. A comparative clinical study using resonance frequency analysis. Appl Osseointegration Res 2001;2:27-29

3 24 Glauser R, Gottlow J, Lundgren AK, Sennerby L, Portmann M, Ruhstaller P, Hämmerle CHF. Immediate occlusal loading of Brånemark MkIV TiUnite implants placed in bone quality 4. Appl Osseointegration Res 2002;3: Glauser R, Lundgren AK, Gottlow J, Sennerby L, Portmann M, Ruhstaller P, Hämmerle CHF. Immediate occlusal loading of Brånemark MkIV TiUnite implants placed predominantly in soft bone: 1-year results of a prospective, clinical study. Clin Implant Dent Relat Res 2003; 5 (suppl 1): Glauser R, Ruhstaller P, Windisch S, et al. Immediate occlusal loading of Brånemark system TiUnite implants placed predominantly in soft bone: 4-year results of a prospective clinical study. Clin Implant Dent Relat Res 2005;7(Suppl 1): Jungner M, Lundqvist P, Lundgren S. Oxidized titanium implants (Nobel Biocare TiUnite) compared with turned titanium implants (Nobel Biocare mark III) with respect to implant failure in a group of consecutive patients treated with early functional loading and two-stage protocol. Clin Oral Implants Res Jun;16(3): Lundgren S, Brechter M. Preliminary findings of using oxidized titanium implants in reconstructive jaw surgery. Appl Osseointegration Res 2002;3: Olsson M, Urde G, Andersen JB, Sennerby L. Early loading of maxillary fixed cross-arch dental prostheses supported by six or eight oxidized titanium implants: Results after 1 year of loading, case series. Clin Implant Dent Relat Res 2003; 5 (suppl 1): Rocci A, Martignoni M, Gottlow J. Immediate loading of Brånemark System with TiUnite and machined surfaces in the posterior mandible: A randomised, open-ended trial. Clin Implant Dent Relat Res 2003; 12 (suppl 1): Tomatis M, Calandriello R, Rangert B. Immediate loading of Brånemark implants with two different surfaces. EAO Abstract 78. Clin Oral Implants Res 2002;13(4):xxx 32 Vanden Bogaerde L, Pedretti G, Dellacasa P, Mozzati M, Rangert B, Wendelhag I. Early function of splinted implants in maxillas and posterior mandibles, using Branemark System TiUnite implants: an 18-month prospective clinical multicenter study. Clin Implant Dent Relat Res. 2004;6(3): Buchs AU, Hahn J, Vassos DM. Interim clinical study report: A threaded, hydroxylapatite-coated implant Five-year post-restoration safety and efficacy. Oral Implantology 1995; 21: Buchs AU, Hahn J, Vassos DM. Efficacy of threaded hydroxyapatite-coated implants placed in the anterior maxilla. Implant Dent 1995; 4: Buchs AU, Hahn J, Vassos DM. Efficacy of threaded hydroxyapatite-coated implants placed in the posterior mandible in support of fixed prostheses. Implant Dent 1996; 5: Buchs AU, Hahn J, Vassos DM. Efficacy of threaded hydroxyapatite-coated implants in the anterior mandible supporting overdentures. Implant Dent 1996; 5: Groisman M, Barcellos Ferreira HM, Frossard WM, de Menezes Fihlo LM, Harari ND. Clinical evaluation of hydroxyapatite-coated single-tooth implants: A 5-year retrospective study. Pract Proced Aesthet Dent 2001; 13: Hahn J, Vassos DM. Long-term efficacy of hydroxyapatite-coated cylindrical implants. Implant Dent 1997; 6: Jeffcoat MK, McGlumphy EA, Reddy MS, Geurs NC, Proskin H. Success of hydroxyapatite vs titanium implants: 5 year results. (Abstract) J Dent Res 81 (Spec Iss A) Jeffcoat MK, McGlumphy EA, Reddy MS, Geurs NC, Proskin H. A comparison of hydroxyapatite (HA)-coated threaded, HA-coated cylindrical, and titanium threaded endosseous dental implants. Int J Oral Maxillofac implants 2003;18: Saadoun AP, LeGall ML. Clinical results and guidelines on SteriOss endosseous implants. Int J Periodont Rest Dent 1992; 12: Chaushu G, Chaushu S, Tzohar A, Dayan D. Immediate loading of single-tooth implants: Immediate versus nonimmediate implantation. A clinical report. Int J Oral Maxillofac implants 2001; 16: Rungcharassaeng K, Lozada JM, Kan JYK, Kim JS, Campagni WV, Munoz CA. Peri-implant tissue response of immediately loaded, threaded, HA-coated implants: 1-year results. J Prosthet Dent 2002; 87: Vassos D. Single-stage surgery for implant placement: A retrospective study. J Oral Implantol. 1997; 23: Callan D, Hahn J, Hebel K, Kwong-Hing A, Smiler D, Vassos D, Wöhrle P, Zosky J. Retrospective multicenter study of an anodized, tapered, diminishing thread implant: Success rate at exposure. Implant Dent 2000; 9: Kan JYK, Rungcharassaeng K. Immediate placement and provisionalization of maxillary anterior single implants: A surgical and prosthodontic rationale. Pract Periodontics Aesthet Dent 2000; 12:

4 47 Kan JYK, Rungcharassaeng K, Lozada J. Immediate placement and provisionalization of maxillary anterior single implants: 1-year prospective study. Int J Oral Maxillofac implants 2003; 18: Kirketerp P, Andersen J B, Urde G. Replacement of extracted anterior teeth by immediately loaded Replace Select HAcoated implants. A one-year follow-up of 35 patients. Applied Osseointegration Research 2002; 3:40 49 Proussaefs P, Kan J, Lozada J, Kleinman A Farnos A. Effects of immediate loading with threaded hydroxyapatitecoated root-form implants on single premolar replacement: A preliminary report. Int J Oral Maxillofac Implants 2002; 17: Wöhrle PS. Single tooth replacement in the aesthetic zone with immediate provisionalization. Fourteen consecutive case reports. Pract Periodontics Aesthet Dent 1998; 9: De Lange G, Tadjoedin E. Fate of the HA coating of loaded implants in the augmented sinus floor: A human case study of retrieved implants. Int J Periodontics Restorative Dent 2002; 22: Proussaefs PT, Tatakis DN, Lozada J, Caplanis N, Rohrer MD. Histologic evaluation of hydroxyapatite-coated rootform implants retrieved after 7 years in function: A case report. Int J Oral Maxillofac implants 2000; 15: Proussaefs P, Lozada J, Ojano M. Histologic evaluation of threaded HA-coated root-form implants after 3.5 to 11 years of function: A report of three cases. Int J Periodontics Restorative Dent 2001; 21: Proussaefs P. Histologic evaluation of threaded hydroxyapatite-coated root-form implant located at a dehisced maxillary site and retrieved from a human subject: A clinical report. J Prosthet Dent 2002; 87: Calandriello R, Tomatis M. Simplified treatment of the atrophic posterior maxilla via immediate/early function and tilted implants: a prospective 1-year clinical study. Clin Implant Dent Relat Res 2005;7(Suppl 1): Chaussé. Immediate loading of mandibular short implants: 24 cases at 42 months. Clin Oral Impl Res 2004;15(4), Abstract Groisman M, Frossard WM, Ferreira HM, de Menezes Filho LM, Touati B. Single-tooth implants in the maxillary incisor region with immediate provisionalization: 2-year prospective study. Pract Proced Aesthet Dent Mar;15(2):115-22, Kancyper, Baffa, Cagnone, Closal, Rodriguez, Troiano, El-Ebrashi. Immediate loading of implants for single-tooth replacement: A multicenter prospective study of Replace Select implants. Abstract P-99, 19th Annual Meeting 2004, Academy of Osseointegration. 59 Proussaefs P, Lozada J. Immediate loading of hydroxyapatite-coated implants in the maxillary premolar area: threeyear results of a pilot study. J Prosthet Dent Mar;91(3): Umezu, Kan, Rungcharassaeng, Lozada. Immediate loading of maxillary single premolar using the Replace TiUnite implants: Preliminary report of a prospective study. Abstract O-17, 19th Annual Meeting 2004, Academy of Osseointegration. 61 Östman PO, Hellman M, Sennerby L. Direct implant loading in the edentulous maxilla using a bone density adapted surgical protocol and primary implant stability criteria for inclusion. Clin Implant Dent Relat Res 2005;7(Suppl 1): Adell R, Eriksson B, Lekholm U, Brånemark P-I, Jemt T. A long-term follow-up study of osseointegrated implants in the treatment of totally edentulous jaws. Int J Oral Maxillofac Impl 1990;5: Andersson B, Ödman P, Lindvall A-M, Brånemark P-I. Cemented single crowns on osseointegrated implants after 5 years: Results from a prospective study on CeraOne. Int J Prosthodont 1998;11: Andersson B, Ödman P, Lindvall AM, Branemark P-I. Five-year prospective study of prosthodontic and surgical single-tooth implant treatment in general practices and at a specialist clinic. Int J Prosthodont 1998;11: Attard N, Zarb GA. Implant prosthodontic management of posterior partial edentulism: Long-term follow-up of a prospective study. J Can Dent Assoc 2002;68: Attard N, Zarb G. Implant prosthodontic management of partially edentulous patients missing posterior teeth: The Toronto experience. J Prosthet Dent 2003;89: Bergendal T, Engquist B. Implant-supported overdentures: A longitudinal prospective study. Int J Oral Maxillofac Implants 1998;13: Carlsson GE, Lindquist LW, Jemt T. Long-term marginal periimplant bone loss in edentulous patients. Int J Prosthodont 2000;13: Ekelund JA, Lindquist LW, Carlsson GE, Jemt T. Implant treatment in the edentulous mandible: a prospective study on Branemark system implants over more than 20 years. Int J Prosthodont. 2003; 16(6): 602-8

5 70 Eliasson A, Palmqvist S, Svenson B, Sondell K. Five-year results with fixed complete-arch mandibular prostheses supported by 4 implants. Int J Oral Maxillofac Implants 2000;15: Ericsson I, Randow K, Nilner K, Petersson A. Some clinical and radiographical features of submerged and nonsubmerged titanium implants. A 5-year follow-up study. Clin Oral Implants Res 1997;8: Ericsson I, Randow K, Nilner K, Peterson A. Early functional loading of Branemark dental implants: 5-year clinical follow-up study. Clin Implant Dent Relat Res 2000;2: Friberg B, Nilson H, Olsson M, Palmquist C. MkII: the self-tapping Brånemark implant. 5-year results of a prospective 3-center study. Clin Oral Impl Res 1997;8: Gunne J, Åstrand P, Lindh T, Borg K, Olsson M. Tooth-implant and implant supported fixed partial dentures: A 10- year report. Int J Prosthodont 1999;12: Hemmings KW, Schmitt A, Zarb GA. Complications and maintenance requirements for fixed prostheses and overdentures in the edentulous mandible: A 5-year report. Int J Oral Maxillofac Implants 1994;9: Henry PJ, Laney WR, Jemt T, Harris D, Krogh PHJ, Polizzi G, Zarb GA, Herrman I. Osseointegrated implants for single tooth replacement: A prospective 5-year multicenter study. Int J Oral Maxillofac Implants 1996;11: Hultin M, Gustafsson A, Klinge B. Long-term evaluation of osseointegrated dental implants in the treatment of partly edentulous patients. J Clin Periodontol 2000;27: Jemt T. Fixed implant-supported prostheses in the edentulous maxilla. A five-year follow-up report. Clin Oral Impl Res 1994;5: Jemt T, Bergendal B, Arvidson K, Bergendal T, Karlsson U, Linden B, Rundcrantz T, Wendelhag I. Implantsupported welded titanium frameworks in the edentulous maxilla: a 5-year prospective multicenter study. Int J Prosthodont 2002;15: Jemt T, Chai J, Harnett J, Heath MR, Hutton JE, Johns RB, McKenna S, McNamara DC, van Steenberghe D, Taylor R, Watson RM, Herrmann I. A 5-year prospective multi-center follow-up report on overdentures supported by osseointegrated implants. Int J Oral Maxillofac Implants 1996;11: Jemt T, Lekholm U. Oral implant treatment in posterior partially edentulous jaws: A 5-year follow-up report. Int J Oral Maxillofac Impl 1993;8: Lekholm U, van Steenberghe D, Herrmann I, Bolender C, Folmer T, Gunne J, Henry P, Higuchi K, Laney WR, Lindén U. Osseointegrated implants in the treatment of partially edentulous jaws: A prospective 5-year multicenter study. Int J Oral Maxillofac Implants 1994;9: Lekholm U, Gunne J, Henry P, Higuchi K, Lindén U, Bergström C, van Steenberghe D. Survival of the Brånemark Implant in partially edentulous jaws: A 10-year prospective multicenter study. Int J Oral Maxillofac Impl 1999;14: Lindquist LW, Carlsson GE, Jemt T. A prospective 15-year follow-up study of mandibular fixed prostheses supported by osseointegrated implants. Clinical results and marginal bone loss. Clin Oral Impl Res 1996;7: Mengel R, Schröder T, Flores-de-Jacoby L. Osseointegrated implants in patients treated for generalized chronic periodontitis and generalized aggressive periodontitis: 3- and 5-year results of a prospective long-term study. J Periodontol 2001;72: Naert I, Gizani S, Vuylsteke M, van Steenberghe D. A 5-year randomized clinical trial on the influence of splinted and unsplinted oral implants in the mandibular overdenture therapy. Part I: Peri-implant outcome. Clin Oral Impl Res 1998;9: Naert I, Gizani S, Vuylsteke M, Van Steenberghe D. A 5-year prospective randomized clinical trial on the influence of splinted and unsplinted oral implants retaining a mandibular overdenture: prosthetic aspects and patient satisfaction. J Oral Rehabil 1999;26: Naert I, Alsaadi G, van Steenberghe D, Quirynen M. I A 10-year randomized clinical trial on the influence of splinted and unsplinted oral implants retaining mandibular overdentures: peri-implant outcome. Int J Oral Maxillofac Implants Sep-Oct;19(5): Olsson M, Gunne J, Åstrand P, Borg K. Bridges supported by free-standing implants versus bridges supported by tooth and implant. A five-year prospective study. Clin Oral Impl Res 1995;6: Petersson A, Rangert B, Randow K, Ericsson I. Marginal bone resorption at different treatment concepts using Brånemark implants in anterior mandibles. Clin Implant Dent Relat Res 2001;3: Polizzi G, Fabbro S, Furri M, Herrmann I, Squarzoni S. Clinical application of narrow Branemark System implants for single-tooth restorations. Int J Oral Maxillofac Implants 1999;14:

6 92 Polizzi G, Grunder U, Goene R, Hatano N, Henry P, Jackson WJ, Kawamura K, Renouard F, Rosenberg R, Triplett G, Werbitt M, Lithner B. Immediate and delayed implant placement into extraction sockets: A 5-year report. Clin Implant Dent Relat Res 2000;2: Scheller H, Pi Urgell J, Kultje C, Klineberg I, Goldberg PV, Stevenson-Moore P, Navarro Alonso JM, Schaller M, Martinez Corria R, Engquist B, Toreskog S, Kastenbaum F, Smith CR. A 5-year multicenter study on implantsupported single crown restorations. Int J Oral Maxillofac Implants 1998;13: Schnitman PA, Wohrle PS, Rubenstein JE, DaSilva JD, Wang NH. Ten-year results for Brånemark implants immediately loaded with fixed prostheses at implant placement. Int J Oral Maxillofac Implants 1997;12: Smedberg JI, Nilner K, Frykholm A. A six-year follow-up study of maxillary overdentures on osseointegrated implants. Eur J Prosthodont Restor Dent 1999;7: Watson RM, Jemt T, Chai J, Harnett J, Heath MR, Hutton JE, Johns RB, Lithner B, McKenna S, McNamara DC, Naert I, Taylor R. Prosthodontic treatment, patient response, and the need for maintenance of complete implantsupported overdentures: An appraisal of 5 years of prospective study. Int J Prosthodont 1997; 10: Wyatt CC, Zarb GA. Treatment outcomes of patients with implant-supported fixed partial prostheses. Int J Oral Maxillofac Implants 1998;13: Zarb GA, Schmitt A. The longitudinal clinical effectiveness of osseointegrated dental implants: the Toronto study. Part I: Surgical results. J Prosthet Dent 1990;63:451-7 Part II: The prosthetic results. J Prosthet Dent 1989;64:53-61 Part III: Problems and complications encountered. J Prosthet Dent 1990;64: Zarb GA, Schmitt A. Osseointegration and the edentulous predicament. The 10-year-old Toronto study. British Dentistry Journal 1991; 170: Zarb GA, Schmitt A. The longitudinal clinical effectiveness of osseointegrated dental implants in anterior partially edentulous patients. Int J Prosthodont 1993;6: Zarb GA, Schmitt A. The longitudinal clinical effectiveness of osseointegrated dental implants in posterior partially edentulous patients. Int J Prosthodont 1993;6: Zitzmann NU, Schärer P, Marinello CP. Long-term results of implants treated with guided bone regeneration: a 5- year prospective study. Int J Oral Maxillofac Implants 2001;16:355-66

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