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

NCT ID: NCT02161874

Last Updated: 2022-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2020-07-31

Brief Summary

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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

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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

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Partial Edentulism Tooth Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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T3 with DCD tapered implant

T3 with DCD tapered prevail implant

Group Type EXPERIMENTAL

T3 with DCD tapered Prevail implant

Intervention Type DEVICE

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

Nanotite certain tapered implant

Nanotite Certain tapered implant

Group Type ACTIVE_COMPARATOR

Nanotite Certain tapered implant

Intervention Type DEVICE

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

Interventions

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T3 with DCD tapered Prevail implant

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

Intervention Type DEVICE

Nanotite Certain tapered implant

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

Intervention Type DEVICE

Other Intervention Names

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T3 with Nanotite T3 with platform switch Nanotite tapered certain Non-platform switched

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ZimVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicholas Lewis, DMD

Role: PRINCIPAL_INVESTIGATOR

Eastman Dental Hospital

Locations

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Dr. Tommie VanDeVelde

Antwerp, , Belgium

Site Status

Dr. Dominique Caspar

Les Bains, , France

Site Status

Dr. Felix Hanssler

Göppingen, , Germany

Site Status

Dr. Nicholas Lewis

London, , United Kingdom

Site Status

Countries

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Belgium France Germany United Kingdom

Other Identifiers

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3023

Identifier Type: -

Identifier Source: org_study_id

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