Clinical Trial: Study on OsseoSpeed™ Implants in Patients Missing 2-5 Teeth in the Posterior Lower Jaw, Restored With Permanent Teeth Attached 6-7 Weeks Later
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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
Brief Summary: 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.
Detailed Summary:
Sponsor: Dentsply Sirona Implants
Current Primary Outcome:
- Implant Survival Rate [ Time Frame: At 5 year follow-up ]An implant that has failed to osseointegrate, lost its osseointegration or fractured will be considered a failure effective from the date of removal. The survival rate for individual implants will be analyzed at each visit. Cumulative implant survival rate will be calculated using Kaplan-Meier life-table estimation and reported as percentage of survived implants.
- Implant Stability [ Time Frame: At 1 year follow-up ]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.
- Marginal Bone Adaptation [ Time Frame: At 5 year follow-up ]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 visit will be compared to values obtained Baseline (loading). Positive value indicates bone gain and negative value bone loss.
Original Primary Outcome: Implant Survival Rate [ Time Frame: From implant placement until 5-year follow-up ]
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Dentsply Sirona Implants
Dates:
Date Received: July 7, 2008
Date Started: February 2004
Date Completion:
Last Updated: August 22, 2013
Last Verified: August 2013