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

Sponsored by:	Biomet 3i, LLC
Information provided by:	Biomet, Inc.
ClinicalTrials.gov Identifier:	NCT00728884

Purpose

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).

Condition
Edentulism

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Observational Study of Certain Prevail Implant System in Maxillary and Mandibular Regions

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:

osseous integration [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

crestal bone resorption [ Time Frame: one year ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	15
Study Start Date:	October 2005
Estimated Study Completion Date:	July 2009
Primary Completion Date:	February 2007 (Final data collection date for primary outcome measure)

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, 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 15 patients.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
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.

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00728884

Locations

Austria
Medizinische Universitat Graz- Klinische Abteilung fur Zahnersatzkunde
Graz, Austria, 8036

Sponsors and Collaborators

Biomet 3i, LLC

Investigators

Principal Investigator:

Martin Lorenzoni, DMD, MD, PhD

Medizinische Universitat Graz

More Information

Responsible Party:	Biomet 3i, LLC ( Jim Kenealy, Pharm. D.; Director Clinical Research )
Study ID Numbers:	2406
Study First Received:	August 1, 2008
Last Updated:	August 5, 2008
ClinicalTrials.gov Identifier:	NCT00728884
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Biomet, Inc.:

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

ClinicalTrials.gov processed this record on January 13, 2009