Randomized Study of Osseotite Certain Tapered Prevails vs. Osseotite Certain Tapered

Not Applicable

Completed

• Conditions: Partial Edentulism; Tooth Disease
• Interventions: Device: Osseotite Certain Tapered Prevail; Device: Osseotite Certain Tapered

• Registration Number: NCT01529775
• Lead Sponsor: ZimVie

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

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2012-02-07
• Study First Submitted QC: 2012-02-08
• Study First Posted: 2012-02-09
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-24
• Last Update Posted: 2022-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Osseotite Certain Tapered Prevail	Osseotite Certain Tapered Prevail	Osseotite Certain Tapered Prevail design with platform switching feature
Osseotite Certain Tapered	Osseotite Certain Tapered	Osseotite Certain Tapered implant with non-platform switching design

Primary Outcome Measures

Name	Time	Method
Cumulative Success Rate	3 years	An implant will be considered successful if it is immobile when tested at various study time point

Secondary Outcome Measures

Name	Time	Method
Crestal Bone Regression	3 years	Differences in crestal bone levels obtained at various study time points will be compared between the two implant designs

Trial Locations

Locations (1)

Universidad Finis Terrae; 🇨🇱 Santiago, Chile