An Observational Clinical Study of the T3 Dental Implant System

Edentulous Jaw Clinical Trial

— Kashmir  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05062863
• Other study ID #: 1804
• Status: Active, not recruiting
• Start date: October 20, 2021
• Est. completion date: June 2025

Study information

• Verified date: September 2023
• Source: ZimVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

This study aims to enroll a total of 140 patients (140 implants) who are in need of treatment with dental implants in one or more edentulous areas of the maxilla and/or mandible. Approximately 4 sites will be participating, each one contributing 35 patients to the study dataset.

The main objectives of this study will be:

1. The integration success of the dental implant (as measured by mobility)

2. The measured changes in peri-implant crestal bone levels for each implant

3. Confirmation of clinical benefits

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 140
• Est. completion date: June 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients of either sex and at least 18 years of age.

2. 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.

3. Prior extracted sites or simultaneous extraction/implant placement.

4. Patients must be physically able to tolerate conventional surgical and restorative procedures.

5. Patients who provide a signed informed consent.

6. Patients who agree to be evaluated for each study visit.

Exclusion Criteria:

1. Patients who are known to be pregnant at the screening visit or planning to become pregnant within 6 months of study enrollment.

2. Patients who have previously failed dental implants at the site intended for study implant placement.

3. Patients with active HIV or Hepatitis infection.

Related Conditions & MeSH terms

• Edentulous Jaw
• Jaw, Edentulous

Intervention

Device:
• T3 dental implant system
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).

Locations

Country	Name	City	State
Germany	Dr. Daniel Engler-Hamm	München
United States	University of Florida	Gainesville	Florida
United States	Jersey Shore University Medical Center	Neptune	New Jersey
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
ZimVie

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dental implant integration	The integration success measured by lack of mobility	2 years
Secondary	Crestal Bone Loss	The measured changes in peri-implant crestal bone levels	2 years