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

Not Applicable

Completed

• Conditions: Partial Edentulism; Tooth Disease
• Interventions: Device: T3 with DCD tapered Prevail implant; Device: Nanotite Certain tapered implant

• Registration Number: NCT02161874
• Lead Sponsor: ZimVie

Brief 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.

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.

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2014-06-10
• Study First Submitted QC: 2014-06-10
• Study First Posted: 2014-06-12
• Primary Completion: 2019-01
• Study Completion: 2020-07
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-24
• Last Update Posted: 2022-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
T3 with DCD tapered implant	T3 with DCD tapered Prevail implant	T3 with DCD tapered prevail implant
Nanotite certain tapered implant	Nanotite Certain tapered implant	Nanotite Certain tapered implant

Primary Outcome Measures

Name	Time	Method
Cumulative success rate	1 year	Implant mobility is assessed by clinical evaluations and correlation to initial placement stability- insertion torque profiles.

Secondary Outcome Measures

Name	Time	Method
Crestal bone changes	2 years	Crestal bone regression (amount of bone loss) between the two treatment groups will be compared

Trial Locations

Locations (4)

Dr. Felix Hanssler; 🇩🇪 Goppingen, Germany

Dr. Tommie VanDeVelde; 🇧🇪 Antwerp, Belgium

Dr. Dominique Caspar; 🇫🇷 Les Bains, France

Dr. Nicholas Lewis; 🇬🇧 London, United Kingdom