Status:
COMPLETED
A Study of Osseotite Certain Prevail Implants Used to Support Short Fixed Bridges With Immediate Occlusal Loading.
Lead Sponsor:
ZimVie
Conditions:
Partial Edentulism
Tooth Disease
Eligibility:
All Genders
18+ years
Brief Summary
This prospective, multicenter study evaluates the performance of the Osseotite Prevail implant when to support a short fixed bridge with immediate occlusal loading, providing the patient with the use ...
Detailed Description
This is a prospective, observational study in which all the patients will have implants placed and a provisional prosthesis attached within 24 hours of implant surgery. Each restorative case will cons...
Eligibility Criteria
Inclusion
- patients of either sex and of any race, 18 years of age or older
- patients for whom the decision has already been made to use dental implants for treating partial edentulism in the posterior mandible or maxilla using a short span fixed prosthesis of two to four units
- patients must be physically able to tolerate conventional surgical and restorative procedures
- requirements for implant placement include: at least 1mm bone will be available at the buccal and lingual aspect of the implant and at least 1mm of bone below the apex
- patients must agree to return to the clinic for each study follow-up visit
- requirements for prosthetic fabrication include: bone width at least 6mm and a bone height of at least 11mm
Exclusion
- patients with active infection or severe inflammation in the areas intended for implant placement
- patients with a \>10 cigarettes / day smoking habit
- patients with uncontrolled diabetes or metabolic bone disease
- patients with a history of therapeutic radiation to the head
- patients in need of bone grafting at the site of the intended study implant; if at the time of surgery some lateral voids need to be filled this is acceptable and does not exclude the patient from the analysis
- patients who are known to be pregnant
- patients with para-functional habits with evidence of severe bruxing or clenching
- placement of implants into sites with less than sixteen weeks of post-extraction healing; for 3-4 unit cases one implant site may have less than sixteen weeks of healing prior to implant placement
- type III or IV bone characteristics of the intended implant sites
- inter-arch distance of less than 7mm (planned location of implant seating platform to the apposing occlusal landmark)
Key Trial Info
Start Date :
March 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00728962
Start Date
March 1 2005
End Date
October 1 2009
Last Update
April 19 2022
Active Locations (1)
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1
University of Southern California
Los Angeles, California, United States, 90089