What is this study trying to find out about tooth loss?

This study aims to evaluate the safety and performance of the TSX dental implant system for treating tooth loss. Researchers want to understand how well the implants integrate and survive over 2 years. The study is sponsored by ZimVie and focuses on implants placed in the upper and lower jaws.

Who may be eligible for this tooth loss clinical trial?

Adults aged 18 years or older who need dental implants in the upper or lower jaw may be eligible. Participants must have adequate bone and opposing teeth for functional occlusion, and must not have uncontrolled systemic diseases or a history of implant failure at the intended site. Please review eligibility criteria for more details.

Is there any cost to participate in this tooth loss clinical trial?

Study-related care, including the implant procedure and all trial visits, is provided at no cost. However, personal travel expenses and other costs related to attending visits may vary and are not guaranteed to be covered.

Actively Recruiting

Age: 18Years +

All Genders

ID06571812

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

Led by ZimVie · Updated on 2026-07-28

Participants Needed

Research Sites

17 weeks

Total Duration

AI-Summary

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.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Patients at least 18 years of age
Decision already made to use a dental implant in an edentulous or immediately removed tooth site in the mandible or maxilla
Sites planned for immediate extraction and restoration should have intact bony walls (Type I sockets); Type II considered by clinician discretion
Previously extracted sites healed for at least 3-4 months
Presence of opposing dentition that allows functional occlusion
Implant site with at least 10mm alveolar bone height and sufficient restorative space, with only minor augmentation if needed
Physically able to tolerate conventional surgical and restorative procedures
Signed informed consent provided
Agreement to be evaluated at each study visit

You will not qualify if you...

Known uncontrolled systemic diseases such as diabetes, endocrine, heart, immune, or mental disorders
Current use of bisphosphonates
Active infection or severe inflammation at treatment areas
Smoking more than 10 cigarettes per day
History of therapeutic radiation to the head or jaw
Pregnant or planning pregnancy within 6 months of enrollment
Untreated severe parafunctional habits like bruxism or clenching
Previous dental implant failure at the intended implant site
HIV or active Hepatitis infection
History of untreated generalized severe periodontitis

Research Team

Hai Bo Wen

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