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Clinical Trials/NCT01529775
NCT01529775
Completed
Not Applicable

A Prospective Randomized-controlled Evaluation of the Osseotite Certain Tapered Prevail Implant for the Preservation of Crestal Bone

ZimVie1 site in 1 country92 target enrollmentNovember 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Partial Edentulism
Sponsor
ZimVie
Enrollment
92
Locations
1
Primary Endpoint
Cumulative Success Rate
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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

Detailed Description

The Osseotite Certain Prevail implant with its platform switch feature will demonstrate higher success rate than the non-platform Osseotite Certain implant

Registry
clinicaltrials.gov
Start Date
November 2010
End Date
December 2016
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
ZimVie
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Cumulative Success Rate

Time Frame: 3 years

An implant will be considered successful if it is immobile when tested at various study time point

Secondary Outcomes

  • Crestal Bone Regression(3 years)

Study Sites (1)

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