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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04236336
Other study ID # 1803
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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