A Clinical Study of the TSV Dental Implant System
Blue Sky
A Prospective, Observational Clinical Study of the Safety and Effectiveness of the TSV Dental Implant System
1 other identifier
observational
104
2 countries
5
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2019
Longer than P75 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2019
CompletedFirst Submitted
Initial submission to the registry
January 17, 2020
CompletedFirst Posted
Study publicly available on registry
January 22, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2024
CompletedJuly 23, 2024
July 1, 2024
4.5 years
January 17, 2020
July 22, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Crestal bone loss at 2 years
2 years
Interventions
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.
Eligibility Criteria
The patients selected will be considered exposed from the time of implant placement until the end of the study (2 years). All patients enrolled in this study will be included in the final analysis (whether complete study per protocol or not).
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ZimVielead
Study Sites (5)
Louisiana State University-New Orleans
New Orleans, Louisiana, 70119, United States
Dr. Amar Katranji
Ann Arbor, Michigan, 48108, United States
Dr. Monish Bhola
Livonia, Michigan, 48150, United States
Dr. Amar Katranji
Southfield, Michigan, 48034, United States
Dr. Guillermo Pradies
Madrid, 28007, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 17, 2020
First Posted
January 22, 2020
Study Start
October 1, 2019
Primary Completion
March 30, 2024
Study Completion
July 1, 2024
Last Updated
July 23, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share