Study on OsseoSpeed™ Implants Replacing 2-5 Teeth in the Posterior Upper Jaw, Restored With Provisional Teeth Attached 6-7 Weeks Later
The purpose of the study is to evaluate Astra Tech Dental Implant System, Fixture Osseospeed™, in patients with tooth loss in the posterior maxilla in an early loading protocol. Primary objectives are implant stability, marginal bone adaptation and survival rate.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open, Prospective Study to Evaluate Implant Stability, Marginal Bone Adaptation and the Survival Rate of Astra Tech Dental Implant System, Fixture Osseospeed™, in Patients With Tooth Loss in the Posterior Maxilla in an Early Loading Protocol.|
- Implant Survival Rate [ Time Frame: At 5 year follow-up ] [ Designated as safety issue: No ]An implant that has failed to osseointegrate, lost its osseointegration or fractured was considered a failure effective from the date of removal. The survival rate for individual implants was analyzed at each visit. Cumulative implant survival rate was calculated using Kaplan-Meier life-table estimation and reported as percentage of survived implants.
- Implant Stability [ Time Frame: At 1 year follow-up ] [ Designated as safety issue: No ]Implant stability was evaluated using Resonance Frequency Analysis (RFA). The RFA value was automatically translated into an Implant Stability Quotient index (ISQ), which runs from 1 to 100. The ISQ value indicates the level of stability. Low values (<60) indicate low stability, medium values (60-70) indicate medium stability and high values (>70) indicate high stability.
- Marginal Bone Adaptation [ Time Frame: At baseline (loading) and at 5 year follow-up ] [ 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 follow-up visit were compared to values obtained Baseline (loading). Positive value indicates bone gain and negative value bone loss.
|Study Start Date:||December 2003|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00711113
|United States, Iowa|
|University of Iowa, College of Dentistry, Dow's Institute for Dental Research|
|Iowa City, Iowa, United States, 52242-1010|
|United States, Texas|
|San Antonio, Texas, United States, 78229|
|Universitetsklinik Mainz, Klinik fur ZMK|
|Mainz, Germany, D-551 31|
|Principal Investigator:||James T Mellonig, D.D.S., M.S||University of Texas|