Study on OsseoSpeed™ Implants in Patients Missing 2-5 Teeth in the Posterior Lower Jaw, Restored With Permanent 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 mandible 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 Mandible 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 will be considered a failure effective from the date of removal. Implant Survival Rate will be reported as percentage of failed implants.
- Implant Stability [ Time Frame: At 1 year follow-up ] [ Designated as safety issue: No ]Implant stability will be evaluated using Resonance Frequency Analysis (RFA). The RFA value is automatically translated into an Implant Stability Quotient index (ISQ), which runs from 1 to 100. Implants with a high primary stability (ISQ >65) appear to maintain a similar level of stability or to decrease somewhat in ISQ with time. Implants with a lower primary stability (ISQ 50-60) appear to display an increase in ISQ with time. Implants with low primary stability (ISQ <50) are more prone to failure. Implant stability changes over time will be determined by changes in absolute ISQ values.
- Marginal Bone Adaptation [ Time Frame: At 5 year follow-up ] [ Designated as safety issue: No ]Marginal bone adaptation will be 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 visits will be compared to values obtained at Fixture Placement and Baseline.
|Study Start Date:||February 2004|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
|United States, Ohio|
|The Ohio State University, College of Dentistry|
|Columbus, Ohio, United States, 43210-1241|
|United States, Washington|
|University of Washington, Dept. of Restorative Dentistry|
|Seattle, Washington, United States, 98195|
|Georg-August-Universität, Göttingen, Abt. Mund-, Keifer-, und Gesicthschirurgie|
|Göttingen, Germany, 37075|
|Principal Investigator:||Edwin A McGlumphy, D.D.S.||The Ohio State University, College of Dentistry|