An Observational Clinical Study of the T3 Dental Implant System

Active, not recruiting

• Conditions: Edentulous Jaw

• Registration Number: NCT05062863
• Lead Sponsor: ZimVie

Brief 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.

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 Timeline

• Study First Submitted: 2021-09-21
• Study First Submitted QC: 2021-09-21
• Study First Posted: 2021-09-30
• Study Start: 2021-10-20
• Status Verified: 2023-09
• Last Update Submitted: 2023-11-08
• Last Update Posted: 2023-11-13
• Primary Completion: 2024-12
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 140

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dental implant integration	2 years	The integration success measured by lack of mobility

Secondary Outcome Measures

Name	Time	Method
Crestal Bone Loss	2 years	The measured changes in peri-implant crestal bone levels

Trial Locations

Locations (4)

Dr. Daniel Engler-Hamm; 🇩🇪 München, Germany

Jersey Shore University Medical Center; 🇺🇸 Neptune, New Jersey, United States

University of Florida; 🇺🇸 Gainesville, Florida, United States

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States