NCT04236336

A Clinical Study of the TSV Dental Implant System

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 104 (actual)
• Sponsor: ZimVie · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This clinical study will evaluate patients being treated with the Tapered Screw Vent (TSV) dental implant and determine its safety and performance (effect of treatment of edentulism). The patients treated will experience more benefit from treatment of edentulism with the TSV 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). Specific objectives include: 1. The integration success measured by lack of mobility and resonance frequency assessment 2. The measured changes in peri-implant crestal bone levels 3. Confirmation of clinical benefits Up to 5 sites will be asked to participate (multicenter study); each site will be selected to place implants (approximately 120 implants across all sites, or 30 implants per site) in patients (any geographic region). The duration of the study will be approximately 2.5 years (last follow up visit is at 2 years) from initiation to completion of data analysis and reporting.

Conditions

• Edentulous Jaw

Interventions

Type	Name	Description
DEVICE	TSV dental implant	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.

Timeline

• Start date: 2019-10-01
• Primary completion: 2024-03-30
• Completion: 2024-07-01
• First posted: 2020-01-22
• Last updated: 2024-07-23

Locations

5 sites across 2 countries: United States, Spain

Regulatory

• FDA-regulated device study