Clinical trial NCT06571812: A Clinical Study of the TSX Dental Implant System (Xpresso)
Official title: A Prospective, Observational Clinical Study of the Safety, Effectiveness and Clinical Performance of the TSX Dental Implant System
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tooth Loss
Keywords: dental implant
Lead sponsor: ZimVie
Sponsor class: INDUSTRY
First posted: 2024-08-26
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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) 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.

Eligibility criteria: 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 an edentulous or immediately removed tooth site to be fully restored in the mandible or maxilla.
3. 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
4. Previously extracted sites (healed at least 3-4 months)
5. For all sites, presence of opposing dentition (antagonist may be natural teeth or implant supported prosthesis) that will allow for functional occlusion is essential.
6. 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.
7. 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).
8. Patients who provide a signed informed consent.
9. Patients who agree to be evaluated for each study visit.

Exclusion Criteria:

1. 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.
2. Patients with current use of bisphosphonates.
3. Patients with active infection or severe inflammation in the areas intended for treatment.
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 become pregnant within 6 months of study enrollment.
7. Patients with evidence of untreated severe parafunctional habits such as bruxing or clenching.
8. Patients who have previously failed dental implants at the site intended for study implant placement
9. Patients with HIV or active Hepatitis infection.
10. Patients with a history of untreated generalized severe periodontitis.

Primary outcomes:
measure: The number of implants that reach integration success/ implant survival at 2 years; the number of implants reaching primary stability during placement
timeFrame: 2 years
Secondary outcomes:
measure: The change in bone level (crestal bone regression) measured and compared at various study visits for each study implant
timeFrame: 2 years
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References: