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

ZimVie

Status

Completed

Conditions

Tooth Disease

Partial Edentulism

Treatments

Device: Nanotite Certain tapered implant

Device: T3 with DCD tapered Prevail implant

Study type

Interventional

Funder types

Industry

Identifiers

NCT02161874

3023 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.