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Sponsored by: |
Astra Tech AB |
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Information provided by: | Astra Tech AB |
ClinicalTrials.gov Identifier: | NCT00711113 |
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.
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 Maxilla in an Early Loading Protocol. |
Enrollment: | 47 |
Study Start Date: | December 2003 |
Estimated Primary Completion Date: | December 2011 (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, Iowa | |
University of Iowa, College of Dentistry, Dow's Institute for Dental Research | |
Iowa City, Iowa, United States, 52242-1010 | |
United States, Texas | |
UTHSCSA | |
San Antonio, Texas, United States, 78229 | |
Germany | |
Universitetsklinik Mainz, Klinik fur ZMK | |
Mainz, Germany, D-551 31 |
Principal Investigator: | James T Mellonig, D.D.S., M.S | UTHSCSA |
Responsible Party: | Astra Tech AB ( Head of Therapeutic Area Dental, Clinical Research ) |
Study ID Numbers: | YA-OSS-0001 |
Study First Received: | July 7, 2008 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00711113 History of Changes |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board; Germany: Ethics Commission |
Jaw, Edentulous, Partially (posterior maxilla) |
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 |