Evaluation of Integration Success and Crestal Bone Preservation Biomet 3i's T3 Implant System
This trial is active, not recruiting.
|Conditions||partial edentulism, tooth disease|
|Treatments||t3 with dcd tapered prevail implant, nanotite certain tapered implant|
|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|
|Antwerp, Belgium||Dr. Tommie VanDeVelde||no longer recruiting|
|Les Bains, France||Dr. Dominique Caspar||no longer recruiting|
|Goppingen, Germany||Dr. Felix Hanssler||no longer recruiting|
|London, United Kingdom||Dr. Nicholas Lewis||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (investigator)|
Cumulative success rate
time frame: 1 year
Crestal bone changes
time frame: 2 years
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.
|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.|
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