Overview

This trial is active, not recruiting.

Conditions partial edentulism, tooth disease
Treatments new abutment connection implant, nanotite certain tapered implant
Phase phase 1
Sponsor Biomet, Inc.
Start date August 2011
End date December 2016
Trial size 49 participants
Trial identifier NCT01529879, 3014

Summary

Integration success rates and the preservation of crestal bone will be higher for the experimental device than for the control implants.

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)
Implant with new abutment connection
new abutment connection implant Osseotite Endosseous dental implant
New abutment connection implant
(Active Comparator)
Nanotite Certain Tapered (standard abutment connection) implant
nanotite certain tapered implant Nanotite endosseous dental implant
Nanotite Certain Tapered (standard abutment connection) implant

Primary 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 Evaluation of an Implant System With a Novel Abutment Attachment Design for the Preservation of Crestal Bone
Principal investigator Jorge Arango, DDS
Description In this study patients are randomized to receive either the experimental implant system or the control Nanotite Certain Tapered (standard abutment connection) and assessed for integration success measured by lack of implant mobility and lack of bone loss obtained at various study time points
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Biomet, Inc..