RecruitingNCT06571812

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

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

Sponsor

ZimVie

Enrollment

62 participants

Start Date

Apr 24, 2024

Study Type

OBSERVATIONAL

Conditions

Tooth-loss

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 months following implant placement surgery. The patients will come back for follow-up evaluations yearly for 2 years.

Eligibility

Min Age: 18 Years

Inclusion Criteria9

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 Criteria10

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.