NCT06571812

A Clinical Study of the TSX Dental Implant System (Xpresso)

A Prospective, Observational Clinical Study of the Safety, Effectiveness and Clinical Performance of the TSX Dental Implant System

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 62 (estimated)
• Sponsor: ZimVie · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

A prospective, observational, multicenter study where 62 patients needing implants in the maxilla or mandible will be enrolled. The patients will be restored with a final prosthesis no later than 4 months following implant placement surgery. The patients will come back for follow-up evaluations yearly for 2 years.

Detailed description

This will be a prospective, observational, multicenter study. All implants will be placed in the maxilla or mandible. The patient will either have a temporary prosthesis placed (out of occlusion) immediately (during the same implant placement visit or within 48 hours) or have a temporary or definitive prosthesis placed between 3-16 weeks following implant. Final restorations for all enrolled patients will take place no later than 4 months following implant placement surgery. All restorations will utilize the full range of the ZimVie prosthetic systems. The implant system will be evaluated yearly for 2 years. Patients who are in need of treatment with dental implants in the maxilla and/or mandible. Those patients with tooth sites having prior failed implant(s) or in need of implant revisions, or in need of major bone grafting to be done at the time of implant placement surgery are not eligible for inclusion. A total of 62 implants, will be placed across all participating sites. It is anticipated to have 60 patients, although one patient may contribute more than 1 implant.

Conditions

• Tooth Loss

Interventions

Type	Name	Description
DEVICE	TSX	Treatment of tooth loss with TSX dental implants

Timeline

• Start date: 2024-04-24
• Primary completion: 2026-12-01
• Completion: 2027-06-01
• First posted: 2024-08-26
• Last updated: 2025-11-19

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study