An Observational Study of the T3 Pro Dental Implant System

Running, not enrolling

Conditions studied: Tooth Loss

In brief

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.

Key facts

Study ID

NCT05498662

Run by

ZimVie

People needed

60

Starts

2022-09-08

Expected to finish

2028-04-30

Last updated by the study team

2026-07-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• Louisiana State University Health Sciences Center — New Orleans, Louisiana, United States
• University of Minnesota — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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