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A Clinical Study of the TSV Dental Implant System — Blue Sky  

Edentulous Jaw Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04236336
Study type Observational
Source ZimVie
Contact
Status Active, not recruiting
Phase
Start date October 1, 2019
Completion date June 2024
View Details
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