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

NCT06571812 | Recruiting FDA Device

• 1 other identifier: 2301
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 2

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

Conditions

Tooth Loss

Keywords

dental implant

Outcome Measures

Primary Outcomes (1)

• The number of implants that reach integration success/ implant survival at 2 years; the number of implants reaching primary stability during placement

  Integration success (survival) of the implant will be determined by lack of mobility, no declared pain, absence of radiolucency, absence of infection and reaching primary stability upon final placement of implant until 2 years later.

  2 years

Secondary Outcomes (1)

• The change in bone level (crestal bone regression) measured and compared at various study visits for each study implant

  2 years

Study Arms (1)

TSX dental implant system

treatment of tooth loss with TSX dental implants

Device: TSX

Interventions

TSX DEVICE

Treatment of tooth loss with TSX dental implants

TSX dental implant system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Qualified patients (each patient having at least 1 tooth site treated) newly diagnosed with needing a dental implant (or more than one) in one or more tooth sites (edentulous or sick tooth in need of extraction) in the maxilla and/or mandible. Patients who have had prior implants in the treatment site that have failed (in need of revision) are not eligible for inclusion. \*Potential study participants please note: there are costs associated with the treatment(s) provided in this study.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ZimVie: lead

Study Sites (2)

Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Tooth Loss

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Central Study Contacts

Cristina Matthews

CONTACT

5613896047; cristina.matthews@zimvie.com

Hai Bo Wen, PhD

CONTACT

760-331-9351; haibo.wen@zimvie.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2024
• First Posted: August 26, 2024
• Study Start: April 24, 2024
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): April 30, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

US (2)