A Prospective Observational Study Evaluating the Safety and Performance of TSX Dental Implants for Tooth Loss in the Upper or Lower Jaw

What this Trial Is About

Researchers are conducting a prospective, observational, multicenter study to evaluate the safety, effectiveness, and clinical performance of the TSX dental implant system in patients needing implants in the upper or lower jaw maxilla or mandible. This study involves 62 implants placed in approximately 60 patients who require dental implants to treat tooth loss, excluding those with prior implant failures or major bone grafting needs. The study aims to observe implant integration success and survival over a 2-year period. Participants will receive dental implants using the TSX dental implant system, with temporary prostheses placed either immediately during the implant surgery or within 48 hours, or between 3 to 16 weeks after implant placement. Final restorative treatments using the full range of ZimVie prosthetic systems will be completed no later than 4 months following implant surgery. All implants and restorations will be monitored yearly for 2 years. During the study, participants will attend follow-up visits yearly for 2 years to assess implant integration, survival, and changes in bone levels around the implant sites. Evaluations will include clinical examinations and imaging to measure bone regression and implant stability. Participants must agree to be evaluated at each study visit and provide informed consent. Total participation spans from implant placement surgery through the 2-year follow-up.

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