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

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: Completed
• Conditions: Edentulous Jaw
• Intervention / Treatment: Device: T3 dental implant system

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 (Actual): 139

Contacts and Locations

Study Locations

• Germany
  • München, Germany, 80333
    • Dr. Daniel Engler-Hamm
• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida
  • New Jersey
    • Neptune City, New Jersey, United States, 07753
      • Jersey Shore University Medical Center
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University

Participation Criteria

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

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	The integration success measured by lack of mobility	2 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: ZimVie
• Investigators: Study Director: Hai Bo Wen, PhD, ZimVie

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2021
• Primary Completion (Actual): October 30, 2025
• Study Completion (Actual): February 28, 2026

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): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Mouth Diseases; Stomatognathic Diseases; Jaw Diseases; Tooth Diseases; Mouth, Edentulous; Jaw, Edentulous
• 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