A Clinical Study of the TSV Dental Implant System | NCT04236336

Studies
A Clinical Study of the TSV Dental Implant System

NCT04236336

Sponsor

ZimVie

Status

Completed

Last Update Posted

Jul 23, 2024Actual

Enrollment

104Actual

Phase

Not provided

Conditions

Edentulous Jaw

Interventions

TSV dental implant

Countries

United States
Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2019Actual

Primary Completion Date

Mar 30, 2024Actual

Completion Date

Jul 1, 2024Actual

First Submitted Date

Jan 17, 2020

First Submission Date that Met QC Criteria

Jan 17, 2020

First Posted Date

Jan 22, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 22, 2024

Last Update Posted Date

Jul 23, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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:

The integration success measured by lack of mobility and resonance frequency assessment
The measured changes in peri-implant crestal bone levels
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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

104Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TSV dental implant	Device	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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).

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Louisiana State University-New Orleans		New Orleans	Louisiana	70119	United States
Dr. Amar Katranji

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Apr 29, 2026
Reset	May 21, 2026

Condition Browse Module

MeSH Terms

ID	Term
D007575	Jaw, Edentulous

Ancestor Terms

ID	Term
D007571	Jaw Diseases
D009140	Musculoskeletal Diseases
D009057	Stomatognathic Diseases
D009066	Mouth, Edentulous

Browse Leaves

Not provided

Browse Branches

Not provided

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Apr 29, 2026			May 21, 2026
Jun 16, 2026