Evaluation of the TSX Dental Implant System for Tooth Loss

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

This study is testing the TSX Dental Implant System to see how well it works for people who need dental implants in their upper or lower jaw.

Quick facts

• Study type: Observational
• Enrollment: 62 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: ZimVie (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 2 sites (Columbus, Ohio and 1 other locations)
• Trial ID: NCT06571812 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the TSX Dental Implant System in patients requiring dental implants in the maxilla or mandible. A total of 62 patients will be enrolled, with implants placed and restored within four months following surgery. Participants will receive either a temporary or definitive prosthesis, and follow-up evaluations will occur yearly for two years to monitor outcomes. The study will utilize the full range of ZimVie prosthetic systems for the restorations.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who require dental implants in edentulous or immediately extracted tooth sites with sufficient bone structure.

Not a fit: Patients with prior failed implants, those needing major bone grafting, or those with insufficient bone height for implant placement will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve the outcomes and reliability of dental implants for patients with tooth loss.

How similar studies have performed: Previous studies on dental implant systems have shown promising results, indicating that this approach is supported by existing evidence.

Eligibility criteria

Inclusion Criteria:

1. Patients at least 18 years of age
2. Patients for whom a decision has already been made to use a dental implant in an edentulous or immediately removed tooth site to be fully restored in the mandible or maxilla.
3. Site planned for immediate extraction and immediate restoration should have intact bony walls- Type I (as described in Special Procedures section) sockets as verified by CBCT and during surgery; Type II may be considered at the discretion of the treating clinician
4. Previously extracted sites (healed at least 3-4 months)
5. For all sites, presence of opposing dentition (antagonist may be natural teeth or implant supported prosthesis) that will allow for functional occlusion is essential.
6. The site intended for implant placement should have at least 10mm of alveolar bone height and sufficient restorative space for a restoration; without the need for augmentation except for minor dehiscence, which can be augmented with autogenous bone chips and/or allograft (i.e.: Puros) to improve soft tissue attachment.
7. Patients must be physically able to tolerate conventional surgical and restorative procedures (IV sedation protocols may be used at the discretion of the treating clinician).
8. Patients who provide a signed informed consent.
9. Patients who agree to be evaluated for each study visit.

Exclusion Criteria:

1. Patients with known systemic diseases such as diabetes, endocrine disease, heart disease, immuno-compromised, or mental disorders that are uncontrolled at the time of enrollment.
2. Patients with current use of bisphosphonates.
3. Patients with active infection or severe inflammation in the areas intended for treatment.
4. Patients with more than10 cigarette per day smoking habit.
5. Patients with a history of therapeutic radiation to the head or jaw.
6. Patients who are known to be pregnant at the screening visit or planning to become pregnant within 6 months of study enrollment.
7. Patients with evidence of untreated severe parafunctional habits such as bruxing or clenching.
8. Patients who have previously failed dental implants at the site intended for study implant placement
9. Patients with HIV or active Hepatitis infection.
10. Patients with a history of untreated generalized severe periodontitis.

Where this trial is running

Columbus, Ohio and 1 other locations

• Ohio State University — Columbus, Ohio, United States (Recruiting)
• University of Pennsylvania — Philadelphia, Pennsylvania, United States (Active_not_recruiting)

Study contacts

• Study coordinator: Cristina Matthews

Conditions Tooth Loss; dental implant