Clinical trial NCT04236336: A Clinical Study of the TSV Dental Implant System
Official title: A Prospective, Observational Clinical Study of the Safety and Effectiveness of the TSV Dental Implant System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Edentulous Jaw
Lead sponsor: ZimVie
Sponsor class: INDUSTRY
First posted: 2020-01-22
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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).

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Survival rate of implants at 2 years
timeFrame: 2 years
Secondary outcomes:
measure: Crestal bone loss at 2 years
timeFrame: 2 years
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Louisiana State University-New Orleans
state: Louisiana
city: Ann Arbor
country: United States
facility: Dr. Amar Katranji
state: Michigan
city: Livonia
country: United States
facility: Dr. Monish Bhola
state: Michigan
city: Southfield
country: United States
facility: Dr. Amar Katranji
state: Michigan
city: Madrid
country: Spain
facility: Dr. Guillermo Pradies
Study officials:
References: