Assessment of the Effect of a Novel Surface Roughness Treatment on Dental Implants on Integration Success

Not Applicable

Completed

• Conditions: Partial Edentulism; Tooth Disease
• Interventions: Device: Osseotite Certain Tapered Group B; Device: Osseotite Certain Tapered Group A; Device: Osseotite Certain Tapered Group C

• Registration Number: NCT01529801
• Lead Sponsor: ZimVie

Brief Summary

A study where dental implants with different roughened surfaces will be evaluated for the ability to resist countertorque forces.

Detailed Description

This study on dental implants with different roughened surfaces will assess its ability to resist countertorque testing at various study time points and demonstrate high success

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2012-02-07
• Study First Submitted QC: 2012-02-08
• Study First Posted: 2012-02-09
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-24
• Last Update Posted: 2022-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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
Roughness Group B	Osseotite Certain Tapered Group B	Osseotite Certain Tapered Group B
Roughness group A	Osseotite Certain Tapered Group A	Osseotite Certain Tapered Group A
Roughness Group C	Osseotite Certain Tapered Group C	Osseotite Certain Tapered Group C

Primary Outcome Measures

Name	Time	Method
Primary stability countertorque measures	6 weeks	Resistance to countertorque measures showing primary stability and success of the implant

Secondary Outcome Measures

Name	Time	Method
Cumulative success rate	2 years	Crestal bone regression (amount of bone loss measured) and equivalence in integration success (implant mobility)

Trial Locations

Locations (1)

Hospital San Jose; 🇨🇱 Santiago, Chile