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Sponsored by: |
Biomet 3i, LLC |
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Information provided by: | Biomet, Inc. |
ClinicalTrials.gov Identifier: | NCT00723944 |
This prospective, randomized study evaluates the performance and crestal bone changes difference between the Osseotite Certain Prevail vs the non-lateralized design of the implant.
Study (null) hypothesis: the crestal bone changes that take place after placement and loading of the Osseotite lateralized implants will be the same as for similar but non-lateralized Osseotite Certain implants.
Condition | Intervention |
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Edentulism Dental Implants |
Device: Dental implants Osseotite Prevail Device: Placebo dental implant |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Prospective, Randomized-Controlled Multicenter Study of the Osseotite Certain Lateralized Implanting Short-Span Fixed Bridge Cases for Preservation of Crestal Bone |
Enrollment: | 14 |
Study Start Date: | February 2005 |
Estimated Study Completion Date: | September 2009 |
Primary Completion Date: | August 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Dental implant with lateralized design
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Device: Dental implants Osseotite Prevail
Root form titanium dental implant
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2: Placebo Comparator
Dental implant without the lateralized design
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Device: Placebo dental implant
Dental implant without the lateralized design
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This is a prospective, randomized-controlled study where patients with qualifying partial edentulism will receive a short fixed bridge restoration. Each implant site will be randomized to receive either the test (Osseotite Certain Prevail) or the control non lateralized version of the Osseotite Certain implant. All implants are placed in a single-stage manner with temporary provisionalization taking place two months after implant placement. Enrollment will continue until 10 patients are treated at each participating study center.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Biomet 3i, Inc. ( Jim Kenealy, Pharm.D.; Director Clinical Research ) |
Study ID Numbers: | 2302 |
Study First Received: | July 25, 2008 |
Last Updated: | July 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00723944 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
dental implants Osseotite Certain Prevail Lateralized non-lateralized Osseotite Certain multicenter randomized |
clinical study partial edentulism single stage early loading crestal bone level short fixed bridge |