Overview

This trial has been completed.

Conditions partial edentulism, tooth disease
Treatments osseotite certain tapered group a, osseotite certain tapered group b, osseotite certain tapered group c
Phase phase 1
Sponsor Biomet, Inc.
Start date February 2011
End date November 2016
Trial size 80 participants
Trial identifier NCT01529801, 3011

Summary

A study where dental implants with different roughened surfaces will be evaluated for the ability to resist countertorque 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)
Osseotite Certain Tapered Group A
osseotite certain tapered group a Osseotite endosseous dental implant
Osseotite Certain Tapered with different surface roughness
(Experimental)
Osseotite Certain Tapered Group B
osseotite certain tapered group b Osseotite endosseous dental implant
Osseotite Certain Tapered with different surface roughness
(Experimental)
Osseotite Certain Tapered Group C
osseotite certain tapered group c osseotite endosseous dental implant
Osseotite Certain Tapered with different surface roughness

Primary Outcomes

Measure
Primary stability countertorque measures
time frame: 6 weeks

Secondary Outcomes

Measure
Cumulative success rate
time frame: 2 years

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 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

Additional Information

Official title A Prospective Randomized-controlled Study of the Effect of Surface Topographies on Implant Integration Rates and Clinical Success
Principal investigator Jaime Acuna, DDS
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
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Biomet, Inc..