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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Partial Edentulism, Tooth Disease

Intervention / Treatment
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* Device: T3 with DCD tapered Prevail implant
* Device: Nanotite Certain tapered implant


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: T3 with DCD tapered implant<br>T3 with DCD tapered prevail implant | Device: T3 with DCD tapered Prevail implant<br>* T3 with DCD implant with Certain (internal) connection and platform-switch design<br>* Other names: T3 with platform switch;|
| Active Comparator: Nanotite certain tapered implant<br>Nanotite Certain tapered implant | Device: Nanotite Certain tapered implant<br>* Nanotite (DCD) implant with Certain (internal) connection and non- platform-switch design<br>* Other names: Non-platform switched;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative success rate | Implant mobility is assessed by clinical evaluations and correlation to initial placement stability- insertion torque profiles. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Crestal bone changes | Crestal bone regression (amount of bone loss) between the two treatment groups will be compared | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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edentulism, dental implants, clinical study, endosseous, randomized, crestal bone level, T3, Nanotite Certain, Nanotite Certain Prevail, Tapered