A Clinical Study of the TSX Dental Implant System (Xpresso) (NCT06571812) | Clinical Trial Compass
RecruitingNot Applicable
A Clinical Study of the TSX Dental Implant System (Xpresso)
United States62 participantsStarted 2024-04-24
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
The number of implants that reach integration success/ implant survival at 2 years; the number of implants reaching primary stability during placement