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

Sponsor

ZimVie (Industry)

Overall Status

Completed

CT.gov ID

NCT02161874

Collaborator

(none)

Enrollment

Locations

Arms

Actual Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Partial Edentulism Tooth Disease	Device: T3 with DCD tapered Prevail implant Device: Nanotite Certain tapered implant	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 1, 2013

Actual Primary Completion Date :

Jan 1, 2019

Actual Study Completion Date :

Jul 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: T3 with DCD tapered implant T3 with DCD tapered prevail implant	Device: T3 with DCD tapered Prevail implant T3 with DCD implant with Certain (internal) connection and platform-switch design Other Names: T3 with Nanotite T3 with platform switch
Active Comparator: Nanotite certain tapered implant Nanotite Certain tapered implant	Device: Nanotite Certain tapered implant Nanotite (DCD) implant with Certain (internal) connection and non- platform-switch design Other Names: Nanotite tapered certain Non-platform switched

Arm

Intervention/Treatment

Experimental: T3 with DCD tapered implant

T3 with DCD tapered prevail implant

Device: T3 with DCD tapered Prevail implant

T3 with DCD implant with Certain (internal) connection and platform-switch design

Other Names:

T3 with Nanotite

T3 with platform switch

Active Comparator: Nanotite certain tapered implant

Nanotite Certain tapered implant

Device: Nanotite Certain tapered implant

Nanotite (DCD) implant with Certain (internal) connection and non- platform-switch design

Other Names:

Nanotite tapered certain

Non-platform switched

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Crestal bone changes [2 years]
Crestal bone regression (amount of bone loss) between the two treatment groups will be compared

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.