Status:
COMPLETED
Study of Certain Prevail Implants Used to Treat All Types of Edentulism in the Maxilla and Mandible
Lead Sponsor:
ZimVie
Conditions:
Partial Edentulism
Eligibility:
All Genders
18+ years
Brief Summary
This observational, prospective clinical study evaluates the performance of the Certain Prevail implant system to show potential crestal bone and soft tissue preservation following the crestal bone. I...
Detailed Description
This is a prospective, observational study of patients with partial or complete edentulism treated with the Certain Prevail dental implants. Restorations will consist of single tooth replacements, sho...
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:
- dental implants restored as single tooth replacements, short and long fixed bridges, overdenture, or fixed full denture.
- a temporary healing abutment will be placed on implant during implant placement surgery (single stage procedure).
- 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 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 at the site of the intended study implant for augmentation purposes. Grafting for treatment of dehiscence or fenestration must have occurred at least 8 weeks prior to implant placement surgery
- patients who are pregnant at the screening visit
- patients with evidence of severe para-functional habits such as bruxing or clenching
- patients with less than 6 weeks of healing time post tooth extraction at the intended treatment site
Key Trial Info
Start Date :
October 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT00728884
Start Date
October 1 2005
End Date
December 1 2011
Last Update
January 30 2024
Active Locations (1)
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1
Medizinische Universitat Graz- Klinische Abteilung fur Zahnersatzkunde
Graz, Austria, 8036