Status:
COMPLETED
A Study of the Performance of Certain Prevail Implants Used in Short Fixed Cases
Lead Sponsor:
ZimVie
Conditions:
Partial Edentulism
Tooth Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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) hypot...
Detailed Description
This is a prospective, randomized-controlled study where patients with qualifying partial edentulism received a short fixed bridge restoration. Each implant site was randomized to receive either the t...
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 dental condition specifically: a partially edentulous short fixed case of less than 4 implants in the maxilla or mandible; no cantilevers are 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 visit
Exclusion
- patients with active infection or severe inflammation in the areas intended for the implants
- patients with more than 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 at 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 :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT00723944
Start Date
February 1 2005
End Date
May 1 2011
Last Update
April 19 2022
Active Locations (1)
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1
Charite- Universitatsmedizin Berlin
Berlin, Germany, D-10117