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

Last updated: January 30, 2025
Sponsor: ZimVie
Overall Status: Active - Recruiting

Phase

N/A

Condition

Periodontitis

Treatment

TSX

Clinical Study ID

NCT06571812
2301
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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 anedentulous or immediately removed tooth site to be fully restored in the mandible ormaxilla.

  3. Site planned for immediate extraction and immediate restoration should have intactbony walls- Type I (as described in Special Procedures section) sockets as verifiedby CBCT and during surgery; Type II may be considered at the discretion of thetreating clinician

  4. Previously extracted sites (healed at least 3-4 months)

  5. For all sites, presence of opposing dentition (antagonist may be natural teeth orimplant supported prosthesis) that will allow for functional occlusion is essential.

  6. The site intended for implant placement should have at least 10mm of alveolar boneheight and sufficient restorative space for a restoration; without the need foraugmentation except for minor dehiscence, which can be augmented with autogenousbone chips and/or allograft (i.e.: Puros) to improve soft tissue attachment.

  7. Patients must be physically able to tolerate conventional surgical and restorativeprocedures (IV sedation protocols may be used at the discretion of the treatingclinician).

  8. Patients who provide a signed informed consent.

  9. Patients who agree to be evaluated for each study visit.

Exclusion

Exclusion Criteria:

  1. Patients with known systemic diseases such as diabetes, endocrine disease, heartdisease, immuno-compromised, or mental disorders that are uncontrolled at the timeof enrollment.

  2. Patients with current use of bisphosphonates.

  3. Patients with active infection or severe inflammation in the areas intended fortreatment.

  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 becomepregnant within 6 months of study enrollment.

  7. Patients with evidence of untreated severe parafunctional habits such as bruxing orclenching.

  8. Patients who have previously failed dental implants at the site intended for studyimplant placement

  9. Patients with HIV or active Hepatitis infection.

  10. Patients with a history of untreated generalized severe periodontitis.

Study Design

Total Participants: 62
Treatment Group(s): 1
Primary Treatment: TSX
Phase:
Study Start date:
April 24, 2024
Estimated Completion Date:
June 30, 2027

Study 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) immediately (during the same implant placement visit or within 48 hours) or have a temporary or definitive prosthesis placed between 3-16 weeks following implant. Final restorations for all enrolled patients will take place no later than 4 months following implant placement surgery. All restorations will utilize the full range of the ZimVie prosthetic systems. The implant system will be evaluated yearly for 2 years.

Patients who are in need of treatment with dental implants in the maxilla and/or mandible. Those patients with tooth sites having prior failed implant(s) or in need of implant revisions, or in need of major bone grafting to be done at the time of implant placement surgery are not eligible for inclusion.

A total of 62 implants, will be placed across all participating sites. It is anticipated to have 60 patients, although one patient may contribute more than 1 implant.

Connect with a study center

  • Ohio State University

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

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