Status:
RECRUITING
A Clinical Study of the TSX Dental Implant System (Xpresso)
Lead Sponsor:
ZimVie
Conditions:
Tooth Loss
Eligibility:
All Genders
18+ years
Brief Summary
A prospective, observational, multicenter study where 62 patients needing implants in the maxilla or mandible will be enrolled. The patients will be restored with a final prosthesis no later than 4 mo...
Detailed Description
This will be a prospective, observational, multicenter study. All implants will be placed in the maxilla or mandible. The patient will either have a temporary prosthesis placed (out of occlusion) imme...
Eligibility Criteria
Inclusion
- Patients at least 18 years of age
- 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.
- 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
- Previously extracted sites (healed at least 3-4 months)
- For all sites, presence of opposing dentition (antagonist may be natural teeth or implant supported prosthesis) that will allow for functional occlusion is essential.
- 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.
- 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).
- Patients who provide a signed informed consent.
- Patients who agree to be evaluated for each study visit.
Exclusion
- 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.
- Patients with current use of bisphosphonates.
- Patients with active infection or severe inflammation in the areas intended for treatment.
- Patients with more than10 cigarette per day smoking habit.
- Patients with a history of therapeutic radiation to the head or jaw.
- Patients who are known to be pregnant at the screening visit or planning to become pregnant within 6 months of study enrollment.
- Patients with evidence of untreated severe parafunctional habits such as bruxing or clenching.
- Patients who have previously failed dental implants at the site intended for study implant placement
- Patients with HIV or active Hepatitis infection.
- Patients with a history of untreated generalized severe periodontitis.
Key Trial Info
Start Date :
April 24 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT06571812
Start Date
April 24 2024
End Date
June 1 2027
Last Update
November 19 2025
Active Locations (2)
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1
Ohio State University
Columbus, Ohio, United States, 43210
2
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104