NCT02161874

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: ZimVie · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Partial Edentulism
• Tooth Disease

Interventions

Type	Name	Description
DEVICE	T3 with DCD tapered Prevail implant	T3 with DCD implant with Certain (internal) connection and platform-switch design
DEVICE	Nanotite Certain tapered implant	Nanotite (DCD) implant with Certain (internal) connection and non- platform-switch design

Timeline

• Start date: 2013-04-01
• Primary completion: 2019-01-01
• Completion: 2020-07-01
• First posted: 2014-06-12
• Last updated: 2022-03-29

Locations

4 sites across 4 countries: Belgium, France, Germany, United Kingdom