Study on OsseoSpeed™ Implants Replacing 2-5 Teeth in the Posterior Upper Jaw, Restored With Provisional Teeth Attached 6-7 Weeks Later
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|ClinicalTrials.gov Identifier: NCT00711113|
Recruitment Status : Completed
First Posted : July 8, 2008
Results First Posted : February 7, 2014
Last Update Posted : February 7, 2014
|Condition or disease||Intervention/treatment||Phase|
|Jaw, Edentulous, Partially||Device: OsseoSpeed™||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||47 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||December 2003|
|Actual Primary Completion Date :||September 2011|
OsseoSpeed™, all dimensions
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|