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

NCT00728884 | Completed Results DMC

• 1 other identifier: 2406
• Study Type: observational
• Target: 162
• Locations: 1 country
• Sites: 1

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. 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).

Conditions

Partial Edentulism

Keywords

dental implants; Certain Prevail; multicenter; clinical study; partial edentulism; total edentulism; platform switching; single stage; early loading; crestal bone level; single tooth replacements; short or long fixed bridges; overdenture; fixed denture

Outcome Measures

Primary Outcomes (1)

• Osseous Integration

  one year

Secondary Outcomes (1)

• Crestal Bone Resorption

  four years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

These will be patients who are otherwise seeking dental implant therapy and belong to the study centers' standard patient population.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ZimVie: lead

Study Sites (1)

Medizinische Universitat Graz- Klinische Abteilung fur Zahnersatzkunde

Graz, 8036, Austria

Location

Results Point of Contact

• Title: Clinical Research Manager
• Organization: Biomet 3i LLC

cristina.matthews@biomet.com

5617766722

Study Officials

• Martin Lorenzoni, DMD, MD, PhD

  MEDIZINISCHE UNIVERSITAT GRAZ

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2008
• First Posted: August 6, 2008
• Study Start: October 1, 2005
• Primary Completion: July 1, 2009
• Study Completion: December 1, 2011
• Last Updated: January 30, 2024
• Results First Posted: August 17, 2009

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)