NCT05062863

An Observational Clinical Study of the T3 Dental Implant System

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 140 (estimated)
• Sponsor: ZimVie · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Conditions

• Edentulous Jaw

Interventions

Type	Name	Description
DEVICE	T3 dental implant system	This clinical study will evaluate patients being treated with the T3 dental implant to confirm its safety and performance (effect of treatment of edentulism). The patients treated will experience a benefit from treatment of edentulism with the T3 dental implant system. The patients will be followed prospectively from the time of exposure (dental implant placement surgery) to outcome (implant survival at 2 years).

Timeline

• Start date: 2021-10-20
• Primary completion: 2026-07-01
• Completion: 2026-08-01
• First posted: 2021-09-30
• Last updated: 2025-11-24

Locations

4 sites across 2 countries: United States, Germany

Regulatory

• FDA-regulated device study