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.
Primary Outcome Measures:
- crestal bone and periodontal outcome [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Osseous integration [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
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) |
1: Active Comparator
Dental implant with lateralized design
|
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.