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Sponsored by: |
Astra Tech AB |
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Information provided by: | Astra Tech AB |
ClinicalTrials.gov Identifier: | NCT00711425 |
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.
Condition | Intervention |
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Jaw, Edentulous, Partially |
Device: OsseoSpeed™ |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
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. |
Enrollment: | 45 |
Study Start Date: | February 2004 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental |
Device: OsseoSpeed™
OsseoSpeed™, all dimensions
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 | |
Germany | |
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 |
Responsible Party: | Astra Tech AB ( Head of Therapeutic Area Dental, Clinical Research ) |
Study ID Numbers: | YA-OSS-0002 |
Study First Received: | July 7, 2008 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00711425 History of Changes |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board; Germany: Ethics Commission |
Jaw, Edentulous, Partially (posterior mandible) |
Mouth Diseases Mouth, Edentulous Tooth Diseases Musculoskeletal Diseases |
Stomatognathic Diseases Jaw, Edentulous Tooth Loss Jaw, Edentulous, Partially |
Mouth Diseases Mouth, Edentulous Tooth Diseases Musculoskeletal Diseases |
Jaw Diseases Stomatognathic Diseases Jaw, Edentulous Jaw, Edentulous, Partially |