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Sponsored by: |
Astra Tech AB |
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Information provided by: | Astra Tech AB |
ClinicalTrials.gov Identifier: | NCT00748241 |
The purpose of this study is primarily to evaluate implant survival rate of Astra Tech Fixture ST placed in the posterior maxilla. A one-stage surgical protocol will be used and the implants will be loaded four weeks after implant installation (early loading). Marginal bone levels, plaque and status of the periimplant mucosa will also be evaluated. The subjects will be followed for three years.
Condition | Intervention |
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Jaw, Edentulous, Partially |
Device: Astra Tech Fixture ST |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open Prospective Study to Evaluate the Survival Rate and Marginal Bone Response of Astra Tech Dental Implants, Fixture ST, in Patients With Tooth Loss in the Posterior Maxilla. |
Enrollment: | 19 |
Study Start Date: | September 2000 |
Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental |
Device: Astra Tech Fixture ST
Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, New York | |
Dept. of Prosthodontics, New York Dept of Veterans Affairs Medical Center | |
New York, New York, United States, 10010 | |
Dept. of Periodontology, New York Dept of Veterans Affairs Medical Center | |
New York, New York, United States, 10010 |
Principal Investigator: | Bruce G Valauri, D.D.S. | New York Dept of Veterans Affairs Medical Center |
Principal Investigator: | Michael Toffler, D.D.S. | New York Dept of Veterans Affairs Medical Center |
Responsible Party: | Astra Tech AB ( Head of Therapeutic Area Dental, Clinical Research ) |
Study ID Numbers: | YA-MIC-0002 |
Study First Received: | September 5, 2008 |
Last Updated: | September 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00748241 |
Health Authority: | United States: Food and Drug Administration |
Mouth Diseases Mouth, Edentulous Tooth Diseases Musculoskeletal Diseases |
Stomatognathic Diseases Jaw, Edentulous Tooth Loss Jaw, Edentulous, Partially |
Jaw Diseases |