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

Launched by ZIMVIE · Aug 22, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at the TSX Dental Implant System, specifically how well it works for patients who have lost teeth and need dental implants. The study will involve 62 patients who are at least 18 years old and have already been advised to use a dental implant. To join the study, patients must have enough healthy bone in their jaw to support the implant and should be able to handle the dental procedures needed. However, individuals with certain medical conditions, active infections, or those who smoke heavily may not be eligible.

Participants in this trial can expect to receive their dental implants and have them fully restored within four months. After the surgery, they will return for check-ups each year for two years to monitor their progress. This study is currently recruiting patients of all genders, and it aims to provide valuable information about the effectiveness of the TSX Dental Implant System for people experiencing tooth loss.

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.