A Clinical Study of the TSV Dental Implant System (Blue Sky)

ZimVie

Status: Completed

Conditions: Edentulous Jaw

Treatments: Device: TSV dental implant

Study type: Observational

Funder types: Industry

Identifiers

NCT04236336

1803

Details and patient eligibility

About

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.

Full 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.

Enrollment: 104 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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