A Clinical Study of the TSV Dental Implant System

Completed

Conditions studied: Edentulous Jaw

In brief

This will be a prospective, randomized, observational study. All implants will be placed in either the maxilla or mandible and loaded within 2 months with a provisional or definitive prosthesis. The implants will be evaluated yearly for 2 years.

Key facts

Study ID

NCT04236336

Run by

ZimVie

People needed

104

Starts

2019-10-01

Expected to finish

2024-07-01

Last updated by the study team

2024-07-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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 HIV or Hepatitis infection

Where it is running

• Louisiana State University-New Orleans — New Orleans, Louisiana, United States
• Dr. Amar Katranji — Ann Arbor, Michigan, United States
• Dr. Monish Bhola — Livonia, Michigan, United States
• Dr. Amar Katranji — Southfield, Michigan, United States
• Dr. Guillermo Pradies — Madrid, Spain

Full record on ClinicalTrials.gov

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