Study to Compare Marginal Bone Loss Around Implants From Two Dental Implant Systems.
The purpose of this study is to compare marginal bone level changes between ASTRA TECH Implant System; Fixture ST and Biomet 3i; Osseotite® Implants. Subjects with partial edentulism in the posterior maxilla and/or mandible will be included and a one-stage surgical protocol will be used. Implants will be loaded within 15 weeks from installation. The subjects will be followed for 3 years.
Jaw, Edentulous, Partially
Device: ASTRA TECH Implant System; Fixture ST: Ø 4.5 cm in lengths of 9, 11 and 13 mm.
Device: 3i Osseotite® implant: Ø 4.0 in lengths of 8.5, 10, 11.5 and 13 mm
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open, Randomized Study to Compare Two Dental Implant Systems With Regard to Changes in Marginal Bone Level.|
- Marginal Bone Level Changes [ Time Frame: 3 years after implant placement ] [ Designated as safety issue: No ]Marginal bone adaptation was expressed as the distance from the implant reference point to the most coronal bone-to-implant contact on the mesial and distal side of the implant. Bone adaptation in millimeters at the 3-year follow-up visit were compared to values obtained at Implant placement. Positive value indicates bone gain and negative value bone loss.
|Study Start Date:||December 2002|
|Study Completion Date:||June 2011|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
Experimental: ASTRA TECH Implant System; Fixture ST
Ø 4.5 cm in lengths 9-13 mm
|Device: ASTRA TECH Implant System; Fixture ST: Ø 4.5 cm in lengths of 9, 11 and 13 mm.|
Experimental: Biomet 3i; Osseotite® Implants
Ø 4.0 cm in lengths 8.5-13 mm
|Device: 3i Osseotite® implant: Ø 4.0 in lengths of 8.5, 10, 11.5 and 13 mm|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00746187
|United States, New York|
|Dept. of Implant Dentistry, New York University|
|New York, New York, United States, 10010|
|United States, North Carolina|
|Dept. of Prosthodontics, School of Dentistry, University of North Carolina|
|Chapel Hill, North Carolina, United States, 27599-7450|
|Principal Investigator:||Dennis P Tarnow, D.D.S. Prof.||Dept. of Implant Dentistry, New York University (to March 2011)|
|Principal Investigator:||Stuart Froum, Dr||Dept. of Implant Dentistry, New York University (from March 2011)|