This trial is active, not recruiting.

Conditions partial edentulism, tooth disease
Treatments t3 with dcd tapered prevail implant, nanotite certain tapered implant
Sponsor Biomet, Inc.
Start date April 2013
End date January 2017
Trial size 100 participants
Trial identifier NCT02161874, 3023


This study evaluates the T3 implant system for the preservation of alveolar crestal bone and the establishment of initial integration. The new surface-treated features of the implant may contribute to improved soft and hard tissue healing. The success rate of the T3 implant will be no different than that of the control implant, which possess similar geometry but different surface treatments.

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
T3 with DCD tapered prevail implant
t3 with dcd tapered prevail implant T3 with Nanotite
T3 with DCD implant with Certain (internal) connection and platform-switch design
(Active Comparator)
Nanotite Certain tapered implant
nanotite certain tapered implant Nanotite tapered certain
Nanotite (DCD) implant with Certain (internal) connection and non- platform-switch design

Primary Outcomes

Cumulative success rate
time frame: 1 year

Secondary Outcomes

Crestal bone changes
time frame: 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patients of either sex and any race greater than 18 years of age - Patients for whom a decision has already been made to use dental implants for the restoration of existing edentulism in the mandible or maxilla. - Patients must be physically able to tolerate conventional surgical and restorative procedures. - Patients must agree to be evaluated for each study visit, especially the yearly follow-up visits Exclusion Criteria: - Patients with active infection or severe inflammation in the areas intended for implant placement. - Patients with a > 10 cigarette per day smoking habit. - Patients with uncontrolled diabetes mellitus. - Patients with uncontrolled metabolic bone disease where there is a diagnosis of the following: Osteomalacia, primary or secondary hyperparathyroidism, renal osteodystrophy, or Paget's disease of bone. - Patients with a history of therapeutic radiation to the head - Patients in need of bone grafting at the site of the intended study implant for augmentation purposes. - Patients who are known to be pregnant at the screening visit. - Patients with evidence of severe para-functional habits such as bruxing or clenching.

Additional Information

Official title A Prospective, Randomized-controlled Evaluation of Biomet 3i's T3 Implant System for Integration Success and the Preservation of Crestal Bone
Principal investigator Nicholas Lewis, DMD
Description This prospective, randomized-controlled study will enroll qualified patients with partial edentulism who will be treated with at least two dental implants. Implant sites will be randomly assigned to receive either a test (T3 implant) or control (Nanotite Certain Tapered implant) with an 80:20 (test:control) randomization ratio. All implants will be allowed to integrate without occlusal forces and final restorations will be cemented thereafter. Cumulative success rate and crestal bone regression of both treatment groups will be the primary and secondary study endpoints, respectively.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Biomet, Inc..