An Observational Clinical Study of the T3 Dental Implant System

NCT05062863 | Completed FDA Device

• 1 other identifier: 1804
• Study Type: observational
• Target: 139
• Locations: 2 countries
• Sites: 4

Brief Summary

This will be a prospective, observational study where all implants will be placed in either the maxilla or mandible and loaded immediately (within 48 hours), early (within 6-8 weeks) or delayed (\> 8 weeks) with a provisional or definitive prosthesis. The implants will be evaluated yearly for 2 years.

Conditions

Edentulous Jaw

Outcome Measures

Primary Outcomes (1)

• Dental implant integration

  The integration success measured by lack of mobility

  2 years

Secondary Outcomes (1)

• Crestal Bone Loss

  2 years

Interventions

T3 dental implant system DEVICE

This clinical study will evaluate patients being treated with the T3 dental implant to confirm its safety and performance (effect of treatment of edentulism). The patients treated will experience a benefit from treatment of edentulism with the T3 dental implant system. The patients will be followed prospectively from the time of exposure (dental implant placement surgery) to outcome (implant survival at 2 years).

Also known as: T3 platform switched certain parallel walled (BOPS), T3 non-platform switched certain parallel walled (BOSS), T3 with DCD platform switched certain parallel walled (BNPS), T3 with DCD non-platform switched certain parallel walled (BNSS)

Eligibility Criteria

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

Study Population

Qualified patient will be those patients who have been newly diagnosed with needing a dental implant (or more than one) in one or more edentulous areas 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.

You may qualify if:

• Patients of either sex and at least 18 years of age.
• Patients for whom a decision has already been made to use a dental implant for the restoration of existing edentulism in the mandible and/or maxilla.
• Prior extracted sites or simultaneous extraction/implant placement.
• Patients must be physically able to tolerate conventional surgical and restorative procedures.
• Patients who provide a signed informed consent.
• Patients who agree to be evaluated for each study visit.

You may not qualify if:

• Patients who are known to be pregnant at the screening visit or planning to become pregnant within 6 months of study enrollment.
• Patients who have previously failed dental implants at the site intended for study implant placement.
• Patients with active HIV or Hepatitis infection.

Sponsors & Collaborators

• ZimVie: lead

Study Sites (4)

University of Florida

Gainesville, Florida, 32610, United States

Location

Jersey Shore University Medical Center

Neptune City, New Jersey, 07753, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Dr. Daniel Engler-Hamm

München, 80333, Germany

Location

MeSH Terms

Conditions

Jaw, Edentulous

Condition Hierarchy (Ancestors)

Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth, Edentulous; Mouth Diseases; Tooth Diseases

Study Officials

• Hai Bo Wen, PhD

  ZimVie

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: September 21, 2021
• First Posted: September 30, 2021
• Study Start: October 20, 2021
• Primary Completion: October 30, 2025
• Study Completion: February 28, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3); DE (1)