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Evaluation of Integration Success and Crestal Bone Preservation Biomet 3i's T3 Implant System

Information source: Biomet, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Partial Edentulism; Tooth Disease

Intervention: T3 with DCD tapered Prevail implant (Device); Nanotite Certain tapered implant (Device)

Phase: N/A

Status: Active, not recruiting

Sponsored by: Biomet, Inc.

Official(s) and/or principal investigator(s):
Nicholas Lewis, DMD, Principal Investigator, Affiliation: Eastman Dental Hospital


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.

Clinical Details

Official title: A Prospective, Randomized-controlled Evaluation of Biomet 3i's T3 Implant System for Integration Success and the Preservation of Crestal Bone

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Primary outcome: Cumulative success rate

Secondary outcome: Crestal bone changes

Detailed 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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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


- 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.

Locations and Contacts

Dr. Tommie VanDeVelde, Antwerp, Belgium

Dr. Dominique Caspar, Les Bains, France

Dr. Felix Hanssler, Goppingen, Germany

Dr. Nicholas Lewis, London, United Kingdom

Additional Information

Starting date: April 2013
Last updated: July 27, 2015

Page last updated: August 23, 2015

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