Observational study of the T3 Pro dental implant system for tooth loss

A Prospective, Observational Clinical Study of the Safety, Effectiveness and Clinical Performance of the T3 Pro Dental Implant System

This study looks at how well the T3 Pro dental implant system works for people getting dental implants to replace lost teeth over a two-year period.

Quick facts

• Study type: Observational
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: ZimVie (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 2 sites (New Orleans, Louisiana and 1 other locations)
• Trial ID: NCT05498662 on ClinicalTrials.gov

What this trial studies

This is a prospective, observational, multicenter study involving 60 patients who require dental implants in the maxilla or mandible. Participants will receive either a temporary or definitive prosthesis following implant placement, with final restorations completed within four months. Patients will be monitored with yearly follow-up evaluations for two years to assess the performance of the T3 Pro dental implant system. The study aims to gather data on the effectiveness and outcomes of this implant system in a real-world setting.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who require dental implants in edentulous or immediately removed tooth sites in the maxilla or mandible.

Not a fit: Patients with prior failed implants, those needing major bone grafting at the time of surgery, or those with specific socket conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the effectiveness of the T3 Pro dental implant system, potentially improving outcomes for patients with tooth loss.

How similar studies have performed: While this study is observational, similar studies evaluating dental implant systems have shown promising results, indicating that this approach is supported by prior research.

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

New Orleans, Louisiana and 1 other locations

• Louisiana State University Health Sciences Center — New Orleans, Louisiana, United States (Recruiting)
• University of Minnesota — Minneapolis, Minnesota, United States (Not_yet_recruiting)

Study contacts

• Study coordinator: Cristina Matthews

Conditions Tooth Loss