A Clinical Study of the TSV Dental Implant System

Edentulous Jaw Clinical Trial

— Blue Sky  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04236336
• Other study ID #: 1803
• Status: Active, not recruiting
• Start date: October 1, 2019
• Est. completion date: June 2024

Study information

• Verified date: January 2024
• Source: ZimVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: June 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• 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 HIV or Hepatitis infection

Related Conditions & MeSH terms

• Edentulous Jaw
• Jaw, Edentulous

Intervention

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.

Locations

Country	Name	City	State
Spain	Dr. Guillermo Pradies	Madrid
United States	Dr. Amar Katranji	Ann Arbor	Michigan
United States	Dr. Monish Bhola	Livonia	Michigan
United States	Louisiana State University-New Orleans	New Orleans	Louisiana
United States	Dr. Amar Katranji	Southfield	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
ZimVie

Countries where clinical trial is conducted

United States,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival rate of implants at 2 years	The average change in outcome (implant survival) from baseline (time of exposure or implant placement surgery) to the end of study (2 years) will be analyzed (at the implant level).	2 years
Secondary	Crestal bone loss at 2 years	The average change in outcome (change in bone level) from baseline (time of exposure or implant placement surgery) to the end of study (2 years) will be analyzed (at the implant level).	2 years