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Sponsored by: |
Astra Tech AB |
Information provided by: | Astra Tech AB |
ClinicalTrials.gov Identifier: | NCT00745121 |
The overall objective of the study is to compare treatment with the OsseoSpeed™ implant in the maxilla of postmenopausal women with and without systemic osteoporosis. The hypothesis is that there will be no difference in marginal bone level alterations between the two groups.
Condition | Intervention |
Postmenopausal Osteoporosis Osteopenia Jaw, Edentulous, Partially |
Device: OsseoSpeed™ |
MedlinePlus related topics: | Osteoporosis |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | An Open, Prospective, Non-Randomized, Controlled, Multicenter Study to Evaluate Clinical Outcome of the Astra Tech OsseoSpeed™ Implant in Women Over 60 Years of Age With Osteoporosis/Osteopenia |
Estimated Enrollment: | 104 |
Study Start Date: | August 2008 |
Estimated Primary Completion Date: | June 2015 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
A: Experimental
Patients with osteoporosis/osteopenia.
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Device: OsseoSpeed™
OsseoSpeed™ implants Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm
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B: Experimental
Control (non-osteoporotic/-osteopenic patients).
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Device: OsseoSpeed™
OsseoSpeed™ implants Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm
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Ages Eligible for Study: | 60 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Anna Rydberg | +46317763000 |
Belgium | |||||
Department of Periodontology, Faculty of Medicine, Catholic University of Leuven | Recruiting | ||||
Leuven, Belgium, B-3000 | |||||
Germany | |||||
Zahnklinik | Not yet recruiting | ||||
Würzburg, Germany, DE-97070 | |||||
Sweden | |||||
Department of Oral and Maxillofacial Surgery, Gothenburg University | Not yet recruiting | ||||
Gothenburg, Sweden, SE-405 30 |
Astra Tech AB |
Principal Investigator: | Marc Quirynen, Prof., Dr. | Katholieke Universiteit Leuven |
Responsible Party: | Astra Tech AB ( Head of Therapeutic Area Dental, Clinical Research ) |
Study ID Numbers: | YA-OSS-0007 |
First Received: | September 2, 2008 |
Last Updated: | September 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00745121 |
Health Authority: | Belgium: Institutional Review Board; Germany: Ethics Commission; Sweden: Regional Ethical Review Board |
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