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

Partial Edentulism Clinical Trial

— OAK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02161874
• Other study ID #: 3023
• Status: Completed
• Phase: N/A
• Start date: April 2013
• Est. completion date: July 2020

Study information

• Verified date: March 2022
• Source: ZimVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2020
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Partial Edentulism
• Tooth Disease
• Tooth Diseases

Intervention

Device:
• T3 with DCD tapered Prevail implant
T3 with DCD implant with Certain (internal) connection and platform-switch design
• Nanotite Certain tapered implant
Nanotite (DCD) implant with Certain (internal) connection and non- platform-switch design

Locations

Country	Name	City	State
Belgium	Dr. Tommie VanDeVelde	Antwerp
France	Dr. Dominique Caspar	Les Bains
Germany	Dr. Felix Hanssler	Goppingen
United Kingdom	Dr. Nicholas Lewis	London

Sponsors (1)

Lead Sponsor	Collaborator
ZimVie

Countries where clinical trial is conducted

Belgium,  France,  Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative success rate	Implant mobility is assessed by clinical evaluations and correlation to initial placement stability- insertion torque profiles.	1 year
Secondary	Crestal bone changes	Crestal bone regression (amount of bone loss) between the two treatment groups will be compared	2 years