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Sponsored by: |
Astra Tech AB |
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Information provided by: | Astra Tech AB |
ClinicalTrials.gov Identifier: | NCT00711282 |
The purpose of this study is to evaluate the clinical performance of implants placed in individuals who are about to loose one or more of their upper teeth. The main objective is to study how the surrounding bone tissue reacts to two different shapes of implants. Clinical performance, in wider terms, means esthetics and long lasting function. Half of the patients will receive a cylindrically shaped implant and the other half will receive a conical-cylindrical implant. The implants will be placed and after a healing period of 16 weeks the gum will be re-opened and the bone tissue response clinically evaluated. Permanent artificial tooth/teeth will be attached six weeks after that.
Condition | Intervention |
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Jaw, Edentulous, Partially |
Device: OsseoSpeed™ |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | A Prospective, Randomized, Controlled Study to Evaluate Buccal Bone Preservation Using Fixture MicroThread™ OsseoSpeed™ Placed in Fresh Extraction Sockets the Maxilla. |
Enrollment: | 104 |
Study Start Date: | December 2005 |
Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental |
Device: OsseoSpeed™
OsseoSpeed™ MicroThread™, diameters of 3.5 and 4.0 mm.
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B: Experimental |
Device: OsseoSpeed™
OsseoSpeed™ MicroThread™, diameters of 4.5 and 5.0 mm.
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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:
Italy | |
Studio Odontoiatrico | |
Padova, Italy, 351 25 | |
Spain | |
Department of Periodontics, Faculty of Odontology, Universidad Complutense de Madrid | |
Madrid, Spain, 28040 | |
Switzerland | |
Department of Periodontology, School of Dental Medicine, University of Berne | |
Berne, Switzerland, CH-3010 |
Responsible Party: | Astra Tech AB ( Head of Therapeutic Area Dental, Clinical Research ) |
Study ID Numbers: | YA-OSS-0009 |
Study First Received: | July 7, 2008 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00711282 History of Changes |
Health Authority: | Italy: Ethics Committee; Spain: Comité Ético de Investigación Clínica; Switzerland: Ethikkommission |
Replacement of non-restorable single tooth/teeth |
Mouth Diseases Mouth, Edentulous Tooth Diseases Musculoskeletal Diseases |
Stomatognathic Diseases Jaw, Edentulous Jaw, Edentulous, Partially |
Mouth Diseases Mouth, Edentulous Tooth Diseases Musculoskeletal Diseases |
Jaw Diseases Stomatognathic Diseases Jaw, Edentulous Jaw, Edentulous, Partially |