NCT04237545

A Clinical Study of the T3 Short Dental Implant System

A Prospective, Randomized, Clinical Study of the Safety, Efficacy and Clinical Benefits of the T3® Short Dental Implant System Placed in the Posterior Regions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: ZimVie · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical study will evaluate the safety and performance of the T3 short dental implant when placed in the posterior maxilla and mandible.

Detailed description

This is a prospective, randomized-controlled, multicenter study in which patients in need of dental implants in the posterior maxilla and mandible will be treated with either the T3 short implant (test device) or the T3 standard length implant (control device). Qualified patients will have one or more edentulous areas in the posterior region to be restored using a single crown. All implants will be placed using a single-stage surgical protocol. A provisional or definitive (final) prosthesis will be placed (cemented or screw-retained) within 8 weeks of implant placement. All prosthetic work must be completed no later than 6 months following implant placement surgery. Each site will be selected to place implants (both test and control) in either the DCD or the non-DCD configuration (a total of 30 implants per site). Among all study sites, a total of 120 implants (60 test, 60 control) will be enrolled in this study (any geographic region). The patient will be randomized to receive either the T3 short (test device) or the T3 standard length, ≥10mm, (control device) implant. Only patients meeting the inclusion / exclusion criteria and providing informed consent form will be enrolled into study. The duration of the study will be approximately 4 years from initiation to completion of data analysis and reporting.

Conditions

• Edentulous Jaw

Interventions

Type	Name	Description
DEVICE	T3 short and restoration (prosthesis)	A qualified patient will be treated with a T3 short implant according to randomization assignment during implant placement surgery visit. The implant will then be restored with a prosthesis and followed up for yearly visits for a total of 4 years.
DEVICE	T3 standard length and restoration (prosthesis)	A qualified patient will be treated with a T3 standard length implant according to randomization assignment during implant placement surgery visit. The implant will then be restored with a prosthesis and followed up for yearly visits for a total of 4 years.

Timeline

• Start date: 2019-10-01
• Primary completion: 2026-01-01
• Completion: 2026-01-31
• First posted: 2020-01-23
• Last updated: 2026-02-17

Locations

4 sites across 3 countries: United States, Italy, Spain

Regulatory

• FDA-regulated device study