An Observational Clinical Study of the T3 Dental Implant System (Kashmir)

May 31, 2023 updated by: ZimVie

A Prospective, Observational Clinical Study of the Safety, Effectiveness and Clinical Benefits of the T3 Dental Implant System

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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

Study Type

Observational

Enrollment (Estimated)

140

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • München, Germany, 80333
        • Recruiting
        • Dr. Daniel Engler-Hamm
        • Contact:
  • United States
    • Florida
      • Gainesville, Florida, United States, 32610
    • New Jersey
      • Neptune, New Jersey, United States, 07753
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • Virginia Commonwealth University
        • Contact:
        • Principal Investigator:
          • Rafael Siqueira, DDs, MS, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Qualified patient will be those patients who have been newly diagnosed with needing a dental implant (or more than one) in one or more edentulous areas in the maxilla and/or mandible. Patients who have had prior implants in the treatment site that have failed (in need of revision) are not eligible for inclusion.

Description

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 the restoration 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 restorative procedures.
  5. Patients who provide a signed informed consent.
  6. Patients who agree to be evaluated for each study visit.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dental implant integration
Time Frame: 2 years
The integration success measured by lack of mobility
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Crestal Bone Loss
Time Frame: 2 years
The measured changes in peri-implant crestal bone levels
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ZimVie

Investigators

  • Study Director: Hai Bo Wen, PhD, ZimVie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2021

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

September 21, 2021

First Submitted That Met QC Criteria

September 21, 2021

First Posted (Actual)

September 30, 2021

Study Record Updates

Last Update Posted (Actual)

June 1, 2023

Last Update Submitted That Met QC Criteria

May 31, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1804

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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