Status:
COMPLETED
A Study of Certain Prevail Implants Used for the Preservation of Crestal Bone in Short Fixed Bridge Cases.
Lead Sponsor:
ZimVie
Conditions:
Partial Edentulism
Tooth Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This prospective, randomized study will evaluate the performance of the Osseotite Certain Prevail implant when compared to that of the non-lateralized version of the implant. Study (null) hypothesis:...
Detailed Description
This is a prospective, randomized, longitudinal study in which qualified patients with partial edentulism will receive a short-fixed bridge restoration. Each implant site is randomized to receive eith...
Eligibility Criteria
Inclusion
- patients of either sex and any race greater than 18 years of age
- patients for whom a decision has already been made to use dental implants for treating an existing condition specifically: A partially edentulous short-span fixed case of less than 4 implants in the maxilla or mandible; the prosthesis may be anterior, posterior, or transitionally anterior-posterior; no cantilevers allowed but one interior crown may be a pontic
- patients must be physically able to tolerate conventional surgical and restorative procedures
- patients must agree to be evaluated for each study visit, especially the yearly follow-up visits
Exclusion
- patients with active infection or severe inflammation in the areas intended for implant placement
- patients with a \>10 cigarette per day smoking habit
- patients with uncontrolled diabetes mellitus
- patients with metabolic bone disease
- patients who have had treatment with therapeutic radiation to the head within the past 12 months
- patients in need of allogenic bone grafting a the site of the intended study implant
- patients who are pregnant at the screening visit
- patients with evidence of severe para-functional habits such as bruxing or clenching
- patients with cantilevers and more than one pontic per bridge
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT00728754
Start Date
March 1 2005
End Date
April 1 2011
Last Update
August 20 2024
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104