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Endosseous implants
DENTAL PRODUCT SPOTLIGHT
Endosseous implants Product names: Astra Tech Implants, fully edentulous only; Brånemark System Dental Implants, fully and partially edentulous only; IMZ (4.0-millimeter, or mm) Implant System, fully and partially edentulous only; SteriOss Hydroxyapatite-Coated Titanium Screw Type Dental Implant; Steri-Oss Titanium Screw Type Dental Implant; Oratronics Oster-Loc Standard One-Stage Osseopreservation Implant System, partially edentulous only; ITI Dental Implant System, fully and partially edentulous only; Integral Endosseous Implant System; Integral Omniloc Endosseous Implant System; Omniloc Dental Implant System with Interface Ring; Spline HydroxylapatiteCoated Cylinder Manufacturers: Astra Tech Implants—Astra Tech Inc., 430 Bedford St., Suite 100, Lexington, Mass. 02420, 1-800531-3481, “www.astratech.com”; Brånemark System Dental Implants, IMZ (4.0-mm) Implant System, SteriOss Hydroxyapatite-Coated Titanium Screw Type Dental Implant, Steri-Oss Titanium Screw Type Dental Implant—Nobel Biocare USA Inc., 22725 Savi Ranch Parkway, Yorba Linda, Calif. 92887-4653, 1-800-993-8100, “www.nobelbiocare.com”; Oratronics Oster-Loc Standard One-Stage Osseopreservation Implant System— Oratronics Inc., 405 Lexington Ave., 69th Floor, New York, N.Y. 10174, 1-800-94 BLADE; ITI Dental Implant System—Straumann Co., Reservoir Place, 1601 Trapelo Road, Waltham, Mass. 02451, 1-800-448-8168, “www. straumann.com”; Integral Endosseous Implant System, Integral Omniloc Endosseous Implant System, Omniloc Dental Implant System with Interface Ring, Spline Hydroxylapatite-Coated Cylinder—Sulzer Calcitek Inc., 1900 Aston Ave., Carlsbad, Calif. 92008-7216, 1-800854-6691, “www.calcitek.com” All ADA-Accepted endosseous implants have demonstrated safety and efficacy when used as indicated in fully and/or partially endentulous patients and/or as single tooth implants. The type of prosthesis and anatomical location used in evaluating Accepted implants is identified in the Seal Statement.
ACCEPTED
“(Product Name) is a(n) (Provisionally) Acceptable Endosseous Implant for use in (type of prosthesis and anatomical location). Responsibility for proper selection of patients, for adequate training and experience in the placement of the implant and for providing appropriate information for informed consent rests with the dentist.” —Council on Scientific Affairs, American Dental Association
Considerations for Acceptance: The implant manufacturers listed at left submitted evidence demonstrating that their implants met the criteria for Acceptance according to the ADA Acceptance Program Guidelines for Endosseous Implants (July 1993). Evidence was provided demonstrating that the physical properties (such as modulus of elasticity, strength and surface characteristics) of the implant material are acceptable and biocompatible. Demonstrating biocompatibility requires animal and tissue culture studies on the implant material and any implant coatings (such as hydroxylapatite). In addition, manufacturers must demonstrate that the implant can be sterilized. Clinical studies must demonstrate safety and efficacy of the implant over a three-year period (for provisional Acceptance) and a five-year period (for full Acceptance).
Safety and Efficacy Data: Two examiner-blinded independent clinical studies are required. At least 50 patients per study are recommended. A minimum of 60 percent of the patients in the studies should receive single-tooth implants or short-span fixed partial dentures (three units or less) in the posterior part of the mouth. Implants should be evaluated at regular intervals for a period of five years (three years for provisional Acceptance). The following criteria must be evaluated: dmobility (must not be greater than the mobility of a healthy natural tooth in the same anatomical location); dradiolucency (there should be no radiographic evidence of abnormal peri-implant radiolucency); dbone loss (vertical bone loss should not be more than 1.4 mm at three years and 2 mm at five years); dperiodontal health; deffects on natural teeth abutments connected to implant abutments (any such effects must be reported); dimplant loss; dsuccess rate; dany adverse events. Implants with different characteristics that may affect function— such as different lengths and widths, different coatings, different shapes—must be evaluated separately.
Performance Criteria: An overall success rate of at least 85 percent after a period of five years is required for full acceptance (three years for provisional acceptance). The number of implant failures occurring during the last two years of the study should not be significantly different than throughout all stages of the study. All Accepted implants demonstrated success rates of more than 90 percent.
Benefit of Use: Implants restore natural function, preserve adjacent tooth structure and improve esthetics.
The Dental Product Spotlight appears in JADA each month to help dentists stay current on new products entering the marketplace and receiving the ADA Seal of Acceptance. These reports are prepared by the ADA Division of Science, in cooperation with The Journal of the American Dental Association. All rights reserved.
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JADA, Vol. 132, October 2001 Copyright ©1998-2001 American Dental Association. All rights reserved.
Endosseous implants Product names: Astra Tech Implants, fully edentulous only; Brånemark System Dental Implants, fully and partially edentulous only; IMZ (4.0-millimeter, or mm) Implant System, fully and partially edentulous only; SteriOss Hydroxyapatite-Coated Titanium Screw Type Dental Implant; Steri-Oss Titanium Screw Type Dental Implant; Oratronics Oster-Loc Standard One-Stage Osseopreservation Implant System, partially edentulous only; ITI Dental Implant System, fully and partially edentulous only; Integral Endosseous Implant System; Integral Omniloc Endosseous Implant System; Omniloc Dental Implant System with Interface Ring; Spline HydroxylapatiteCoated Cylinder Manufacturers: Astra Tech Implants—Astra Tech Inc., 430 Bedford St., Suite 100, Lexington, Mass. 02420, 1-800531-3481, “www.astratech.com”; Brånemark System Dental Implants, IMZ (4.0-mm) Implant System, SteriOss Hydroxyapatite-Coated Titanium Screw Type Dental Implant, Steri-Oss Titanium Screw Type Dental Implant—Nobel Biocare USA Inc., 22725 Savi Ranch Parkway, Yorba Linda, Calif. 92887-4653, 1-800-993-8100, “www.nobelbiocare.com”; Oratronics Oster-Loc Standard One-Stage Osseopreservation Implant System— Oratronics Inc., 405 Lexington Ave., 69th Floor, New York, N.Y. 10174, 1-800-94 BLADE; ITI Dental Implant System—Straumann Co., Reservoir Place, 1601 Trapelo Road, Waltham, Mass. 02451, 1-800-448-8168, “www. straumann.com”; Integral Endosseous Implant System, Integral Omniloc Endosseous Implant System, Omniloc Dental Implant System with Interface Ring, Spline Hydroxylapatite-Coated Cylinder—Sulzer Calcitek Inc., 1900 Aston Ave., Carlsbad, Calif. 92008-7216, 1-800854-6691, “www.calcitek.com” All ADA-Accepted endosseous implants have demonstrated safety and efficacy when used as indicated in fully and/or partially endentulous patients and/or as single tooth implants. The type of prosthesis and anatomical location used in evaluating Accepted implants is identified in the Seal Statement.
ACCEPTED
“(Product Name) is a(n) (Provisionally) Acceptable Endosseous Implant for use in (type of prosthesis and anatomical location). Responsibility for proper selection of patients, for adequate training and experience in the placement of the implant and for providing appropriate information for informed consent rests with the dentist.” —Council on Scientific Affairs, American Dental Association
Considerations for Acceptance: The implant manufacturers listed at left submitted evidence demonstrating that their implants met the criteria for Acceptance according to the ADA Acceptance Program Guidelines for Endosseous Implants (July 1993). Evidence was provided demonstrating that the physical properties (such as modulus of elasticity, strength and surface characteristics) of the implant material are acceptable and biocompatible. Demonstrating biocompatibility requires animal and tissue culture studies on the implant material and any implant coatings (such as hydroxylapatite). In addition, manufacturers must demonstrate that the implant can be sterilized. Clinical studies must demonstrate safety and efficacy of the implant over a three-year period (for provisional Acceptance) and a five-year period (for full Acceptance).
Safety and Efficacy Data: Two examiner-blinded independent clinical studies are required. At least 50 patients per study are recommended. A minimum of 60 percent of the patients in the studies should receive single-tooth implants or short-span fixed partial dentures (three units or less) in the posterior part of the mouth. Implants should be evaluated at regular intervals for a period of five years (three years for provisional Acceptance). The following criteria must be evaluated: dmobility (must not be greater than the mobility of a healthy natural tooth in the same anatomical location); dradiolucency (there should be no radiographic evidence of abnormal peri-implant radiolucency); dbone loss (vertical bone loss should not be more than 1.4 mm at three years and 2 mm at five years); dperiodontal health; deffects on natural teeth abutments connected to implant abutments (any such effects must be reported); dimplant loss; dsuccess rate; dany adverse events. Implants with different characteristics that may affect function— such as different lengths and widths, different coatings, different shapes—must be evaluated separately.
Performance Criteria: An overall success rate of at least 85 percent after a period of five years is required for full acceptance (three years for provisional acceptance). The number of implant failures occurring during the last two years of the study should not be significantly different than throughout all stages of the study. All Accepted implants demonstrated success rates of more than 90 percent.
Benefit of Use: Implants restore natural function, preserve adjacent tooth structure and improve esthetics.
The Dental Product Spotlight appears in JADA each month to help dentists stay current on new products entering the marketplace and receiving the ADA Seal of Acceptance. These reports are prepared by the ADA Division of Science, in cooperation with The Journal of the American Dental Association. All rights reserved.
1452
JADA, Vol. 132, October 2001 Copyright ©1998-2001 American Dental Association. All rights reserved.