RECRUITING

An Observational Study of the T3 Pro Dental Implant System

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Prospective, Observational Clinical Study of the Safety, Effectiveness and Clinical Performance of the T3 Pro Dental Implant System

Quick Facts

Study Start:2022-09-08

Study Completion:2025-12-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05498662

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Cristina Matthews

CONTACT

5617766722

cristina.matthews@zimvie.com

Hai Bo Wen, PhD

CONTACT

5617766996

haibo.wen@zimvie.com

Study Locations (Sites)

Louisiana State University Health Sciences Center

New Orleans, Louisiana, 70119

United States

University of Minnesota

Minneapolis, Minnesota, 55455

United States

Collaborators and Investigators

Sponsor: ZimVie

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-08

Study Completion Date2025-12-30

Study Record Updates

Study Start Date2022-09-08

Study Completion Date2025-12-30

Terms related to this study

Additional Relevant MeSH Terms

Tooth Loss