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

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ClinicalTrials.gov Identifier: NCT02161874
Recruitment Status : Completed
First Posted : June 12, 2014
Last Update Posted : January 25, 2021
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : April 2013
Actual Primary Completion Date : January 2019
Actual Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


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




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


Secondary Outcome Measures :
  1. Crestal bone changes [ Time Frame: 2 years ]
    Crestal bone regression (amount of bone loss) between the two treatment groups will be compared



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02161874


Locations
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Belgium
Dr. Tommie VanDeVelde
Antwerp, Belgium
France
Dr. Dominique Caspar
Les Bains, France
Germany
Dr. Felix Hanssler
Goppingen, Germany
United Kingdom
Dr. Nicholas Lewis
London, United Kingdom
Sponsors and Collaborators
Zimmer Biomet
Investigators
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Principal Investigator: Nicholas Lewis, DMD Eastman Dental Hospital
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Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT02161874    
Other Study ID Numbers: 3023
First Posted: June 12, 2014    Key Record Dates
Last Update Posted: January 25, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Zimmer Biomet:
edentulism
dental implants
clinical study
endosseous
randomized
crestal bone level
T3
Nanotite Certain
Nanotite Certain Prevail
Tapered
Additional relevant MeSH terms:
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Tooth Diseases
Stomatognathic Diseases