Overview

This trial is active, not recruiting.

Conditions partial edentulism, tooth disease
Treatments high torque insertion, low torque insertion
Sponsor Biomet, Inc.
Start date December 2010
End date December 2016
Trial size 60 participants
Trial identifier NCT01529736, 3004

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.

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
Arm
(Experimental)
High torque insertion
high torque insertion Osseotite endosseous dental implant
Osseotite implant placed with high insertion torque forces
(Active Comparator)
Low torque insertion
low torque insertion Osseotite endosseous dental implant
Osseotite implant placed with low insertion torque forces

Primary Outcomes

Measure
primary stability countertorque measures
time frame: 4 months

Secondary Outcomes

Measure
cumulative success rate
time frame: 1 year

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 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

Additional Information

Official title Prospective Randomized-controlled Study of the Integration Success of Osseotite Implants Placed With Different Insertion Procedures
Principal investigator Armando Estefan, DMD
Description Osseotite implants will be placed using the standard lower insertion torque forces and compared to implants placed using higher insertion torque forces.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Biomet, Inc..