Randomized Study of Integration Success of Osseotite Dental Implants Placed Using Different Insertion Procedures

Not Applicable

Completed

• Conditions: Tooth Disease; Partial Edentulism
• Interventions: Procedure: High torque insertion; Procedure: Low torque insertion

• Registration Number: NCT01529736
• Lead Sponsor: ZimVie

Brief Summary

Osseotite implants placed with higher insertion torque (TEST procedure) will have higher initial stability and integration success than those placed with lower insertion torque forces.

Detailed Description

Osseotite implants will be placed using the standard lower insertion torque forces and compared to implants placed using higher insertion torque forces.

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2012-02-07
• Study First Submitted QC: 2012-02-07
• 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: 60

Inclusion Criteria

• patients of either sex and older than 18 years of age
• patients needing a minimum of 3 implants 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
High torque insertion	High torque insertion	High torque insertion
Low torque insertion	Low torque insertion	Low torque insertion

Primary Outcome Measures

Name	Time	Method
primary stability countertorque measures	4 months	resistance to countertorque measures showing primary stability success of implants

Secondary Outcome Measures

Name	Time	Method
cumulative success rate	1 year	Crestal bone regression (amount of bone loss measured) and equivalence in integration success (implant mobility)

Trial Locations

Locations (1)

Universidad Javeriana; 🇨🇴 Bogota, Colombia