Clinical Trial: Study on OsseoSpeed™ Implants Replacing 2-5 Teeth in the Posterior Upper Jaw, Restored With Provisional 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 maxilla 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 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 ]
    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 ]
    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.


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: December 2003
Date Completion:
Last Updated: January 9, 2014
Last Verified: January 2014