Study on OsseoSpeed™ Implants in Patients Missing 2-5 Teeth in the Posterior Lower Jaw, Restored With Permanent Teeth Attached 6-7 Weeks Later
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|ClinicalTrials.gov Identifier: NCT00711425|
Recruitment Status : Completed
First Posted : July 8, 2008
Results First Posted : September 26, 2011
Last Update Posted : September 9, 2013
|Condition or disease||Intervention/treatment||Phase|
|Jaw, Edentulous, Partially||Device: OsseoSpeed™||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 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 Mandible in an Early Loading Protocol.|
|Study Start Date :||February 2004|
|Actual Primary Completion Date :||January 2010|
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 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.
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): NCT00711425
|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|