An Observational Clinical Study of the T3 Dental Implant System

Last updated: November 8, 2023
Sponsor: ZimVie
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

N/A

Treatment

T3 dental implant system

Clinical Study ID

NCT05062863
1804
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This will be a prospective, observational study where all implants will be placed in either the maxilla or mandible and loaded immediately (within 48 hours), early (within 6-8 weeks) or delayed (> 8 weeks) with a provisional or definitive prosthesis. The implants will be evaluated yearly for 2 years.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients of either sex and at least 18 years of age.
  2. Patients for whom a decision has already been made to use a dental implant for therestoration of existing edentulism in the mandible and/or maxilla.
  3. Prior extracted sites or simultaneous extraction/implant placement.
  4. Patients must be physically able to tolerate conventional surgical and restorativeprocedures.
  5. Patients who provide a signed informed consent.
  6. Patients who agree to be evaluated for each study visit.

Exclusion

Exclusion Criteria:

  1. Patients who are known to be pregnant at the screening visit or planning to becomepregnant within 6 months of study enrollment.
  2. Patients who have previously failed dental implants at the site intended for studyimplant placement.
  3. Patients with active HIV or Hepatitis infection.

Study Design

Total Participants: 140
Treatment Group(s): 1
Primary Treatment: T3 dental implant system
Phase:
Study Start date:
October 20, 2021
Estimated Completion Date:
June 30, 2025

Study Description

This study aims to enroll a total of 140 patients (140 implants) who are in need of treatment with dental implants in one or more edentulous areas of the maxilla and/or mandible. Approximately 4 sites will be participating, each one contributing 35 patients to the study dataset.

The main objectives of this study will be:

  1. The integration success of the dental implant (as measured by mobility)

  2. The measured changes in peri-implant crestal bone levels for each implant

  3. Confirmation of clinical benefits

Connect with a study center

  • Dr. Daniel Engler-Hamm

    München, 80333
    Germany

    Site Not Available

  • University of Florida

    Gainesville, Florida 32610
    United States

    Site Not Available

  • Jersey Shore University Medical Center

    Neptune, New Jersey 07753
    United States

    Site Not Available

  • Virginia Commonwealth University

    Richmond, Virginia 23298
    United States

    Site Not Available

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