This trial is active, not recruiting.

Conditions partial edentulism, tooth disease
Treatments osseotite certain tapered prevail, osseotite certain tapered
Phase phase 1
Sponsor Biomet, Inc.
Start date November 2010
End date December 2016
Trial size 92 participants
Trial identifier NCT01529775, 3008


This study will demonstrate the benefits of platform switching design of the Osseotite dental implant.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose treatment
Osseotite Certain Tapered Prevail design with platform switching feature
osseotite certain tapered prevail Osseotite endosseous dental implant
Osseotite implant with platform switching feature
(Active Comparator)
Osseotite Certain Tapered implant with non-platform switching design
osseotite certain tapered Osseotite endosseous dental implant
Osseotite implant with non-platform switching feature

Primary Outcomes

Cumulative Success Rate
time frame: 3 years

Secondary Outcomes

Crestal Bone Regression
time frame: 3 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - patients of either sex and older than 18 years of age - patients needing at least one dental implant to treat partial edentulism - patients physically able to tolerate surgical and restorative dental procedures - patients agreeing to all protocol visits Exclusion Criteria: - patients with infection or severe inflammation at the intended treatment sites - patients smoking greater than 10 cigarettes per day - patients with uncontrolled diabetes mellitus - patients with uncontrolled metabolic diseases - patients who received radiation treatment to the head in the past 12 months - patients needing bone grafting at the intended treatment sites - patients known to be pregnant at screening visit - patients with para-functional habits like bruxing and clenching

Additional Information

Official title A Prospective Randomized-controlled Evaluation of the Osseotite Certain Tapered Prevail Implant for the Preservation of Crestal Bone
Principal investigator Manuel Pavez, DDS
Description The Osseotite Certain Prevail implant with its platform switch feature will demonstrate higher success rate than the non-platform Osseotite Certain implant
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Biomet, Inc..