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