An Observational Study of the T3 Pro Dental Implant System

Launched by ZIMVIE · Aug 10, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the T3 Pro Dental Implant System, which is designed to help people who have lost teeth. The trial will enroll 60 patients who need dental implants in either the upper or lower jaw. If you are accepted into the study, you will receive your dental implants and have a final prosthetic tooth placed within four months. After that, you'll come back for yearly check-ups for two years to monitor how well the implants are working.

To be eligible for the trial, you need to be at least 18 years old and have a clear plan to get a dental implant. You should have enough healthy bone in your jaw to support the implant, and you must not have certain health issues, like uncontrolled diabetes or heart disease. If you join the study, you will need to sign a consent form and agree to attend follow-up visits. This study may help improve dental implant procedures and outcomes for future patients, so your participation could contribute to important advancements in dental care.

Gender

ALL

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.