An Observational Study of the TSX Dental Implant System (Xpresso)
- Conditions
- Tooth Loss
- Registration Number
- NCT06571812
- Lead Sponsor
- ZimVie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> 1. Patients at least 18 years of age<br><br> 2. Patients for whom a decision has already been made to use a dental implant in an<br> edentulous or immediately removed tooth site to be fully restored in the mandible or<br> maxilla.<br><br> 3. Site planned for immediate extraction and immediate restoration should have intact<br> bony walls- Type I (as described in Special Procedures section) sockets as verified<br> by CBCT and during surgery; Type II may be considered at the discretion of the<br> treating clinician<br><br> 4. Previously extracted sites (healed at least 3-4 months)<br><br> 5. For all sites, presence of opposing dentition (antagonist may be natural teeth or<br> implant supported prosthesis) that will allow for functional occlusion is essential.<br><br> 6. The site intended for implant placement should have at least 10mm of alveolar bone<br> height and sufficient restorative space for a restoration; without the need for<br> augmentation except for minor dehiscence, which can be augmented with autogenous<br> bone chips and/or allograft (i.e.: Puros) to improve soft tissue attachment.<br><br> 7. Patients must be physically able to tolerate conventional surgical and restorative<br> procedures (IV sedation protocols may be used at the discretion of the treating<br> clinician).<br><br> 8. Patients who provide a signed informed consent.<br><br> 9. Patients who agree to be evaluated for each study visit.<br><br>Exclusion Criteria:<br><br> 1. Patients with known systemic diseases such as diabetes, endocrine disease, heart<br> disease, immuno-compromised, or mental disorders that are uncontrolled at the time<br> of enrollment.<br><br> 2. Patients with current use of bisphosphonates.<br><br> 3. Patients with active infection or severe inflammation in the areas intended for<br> treatment.<br><br> 4. Patients with more than10 cigarette per day smoking habit.<br><br> 5. Patients with a history of therapeutic radiation to the head or jaw.<br><br> 6. Patients who are known to be pregnant at the screening visit or planning to become<br> pregnant within 6 months of study enrollment.<br><br> 7. Patients with evidence of untreated severe parafunctional habits such as bruxing or<br> clenching.<br><br> 8. Patients who have previously failed dental implants at the site intended for study<br> implant placement<br><br> 9. Patients with HIV or active Hepatitis infection.<br><br> 10. Patients with a history of untreated generalized severe periodontitis.
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The number of implants that reach integration success/ implant survival at 2 years; the number of implants reaching primary stability during placement
- Secondary Outcome Measures
Name Time Method The change in bone level (crestal bone regression) measured and compared at various study visits for each study implant