Study of Certain Prevail Implants Used to Treat All Types of Edentulism in the Maxilla and Mandible

Partial Edentulism Clinical Trial

— PrevailMulti  

Official title:

Observational Study of Certain Prevail Implant System in Maxillary and Mandibular Regions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00728884
• Other study ID #: 2406
• Status: Completed
• Start date: October 2005
• Est. completion date: December 2011

Study information

• Verified date: January 2024
• Source: ZimVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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. It will also evaluate implant performance. Study (null) hypothesis: The preservation of crestal bone for the Certain Prevail implants will be the same as that for standard non-platform switched implants from contemporaneous studies (historical controls).

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, short and long fixed bridges, and overdentures and full dentures. All implants are placed using a single stage approach and temporalization occurring after two months of healing (early loading). Each center will strive to enroll a total of 20 patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: December 2011
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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:

1. dental implants restored as single tooth replacements, short and long fixed bridges, overdenture, or fixed full denture.

2. 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 Criteria:

• 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

Related Conditions & MeSH terms

• Partial Edentulism

Locations

Country	Name	City	State
Austria	Medizinische Universitat Graz- Klinische Abteilung fur Zahnersatzkunde	Graz

Sponsors (1)

Lead Sponsor	Collaborator
ZimVie

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Osseous Integration		one year
Secondary	Crestal Bone Resorption	Crestal bone level measures- changes from baseline to last study visit	four years