An Observational Study of the T3 Pro Dental Implant System

NCT05498662 | Active Not Recruiting FDA Device

• 1 other identifier: 2201
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

A prospective, observational, multicenter study where 60 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

Outcome Measures

Primary Outcomes (1)

• Integration success/ implant survival at 2 years; primary stability

  the lack of implant mobility observed during 2 years duration; primary stability of the implant reached during implant placement as measured by placement torque and Resonance Frequency measures

  2 years

Secondary Outcomes (1)

• Crestal bone regression

  2 years

Interventions

T3 Pro dental implant system DEVICE

treatment of tooth loss with T3 Pro dental implants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• 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)

Louisiana State University Health Sciences Center

New Orleans, Louisiana, 70119, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Tooth Loss

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Study Design

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

Study Record Dates

• First Submitted: August 10, 2022
• First Posted: August 12, 2022
• Study Start: September 8, 2022
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): April 30, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)