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Hexarelin

Examorelin, HEX

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Studies 233
Trials 61
Active Not Recruiting NA INTERVENTIONAL NCT04237545

A Clinical Study of the T3 Short Dental Implant System

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief 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.

Interventions

Name: T3 short and restoration (prosthesis)
Type: DEVICE
Description: 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.
Name: T3 standard length and restoration (prosthesis)
Type: DEVICE
Description: 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.

Primary Outcomes

Measure: Crestal Bone regression
TimeFrame: 4 years
Description: Assess and compare peri-implant crestal bone level changes between test and control device from baseline to 4 years

Trial Information

NCT ID

NCT04237545

Status

Active Not Recruiting

Study Type

INTERVENTIONAL

Phases

NA

Sponsor

ZimVie

Last Updated

December 15, 2025