NCT04236336

Completed

A Clinical Study of the TSV Dental Implant System

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Other study identifiers

Sponsor study identifier

1803

Study Type

observational

Actual enrollment (reported)

104

Locations

2 countries

Sites

5

Timeline

Study Start

October 1, 2019

Actual (reported)

Primary Completion

March 30, 2024

Actual (reported)

Study Completion

July 1, 2024

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 104 participants
Study completion date: July 1, 2024
Actual (reported)
Listed locations: 2 countries · 5 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
October 1, 2019
Actual (reported)
First Submitted
January 17, 2020
Actual (reported)
First Posted
January 22, 2020
Actual (reported)
Primary Completion
March 30, 2024
Actual (reported)
Study Completion
July 1, 2024
Actual (reported)

Last Updated: July 23, 2024
Status Verified: July 2024
Last Update Submitted: July 22, 2024

Conditions

Edentulous Jaw

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

TSV dental implantDevice

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.

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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).

You may qualify if:

Patients of either sex and at least 18 years of age

Sponsors & Collaborators

ZimVie
Industrylead

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

Jaw, Edentulous

Condition Hierarchy (Ancestors)

Jaw DiseasesMusculoskeletal DiseasesStomatognathic DiseasesMouth, EdentulousMouth DiseasesTooth Diseases

Enrollment

104 participants (actual enrollment reported by the registry).

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

Actual (reported)

NCT05924451

Study of Hard and Soft Tissue Behavior Around Abutments on Implants.

Not ApplicableCompleted

NCT05972148

Precision of Complete-arch Digital Implant Impressions With Intraoral Scanning Versus Photogrammetry

Not ApplicableCompleted

NCT03992300

Comparison of Full-arch Implant-supported Frameworks From an Intraoral Scanning or From a Conventional Impression

Not ApplicableCompleted

NCT05709236

Digital Versus Conventional Full-arch Implant Impression in Maxillary Screw- Retained Implant Prosthesis

Not ApplicableCompleted

NCT06408506

In-patient Comparison of Immediately Loaded and Non-loaded Submerged and Transgingival Healed Implants Within 4 Months

Not ApplicableCompleted

NCT06349525

Retention of Telescopic Versus Locator Attachments

Not ApplicableCompleted

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.

Primary Completion

March 30, 2024

Actual (reported)

Study Completion

July 1, 2024

Actual (reported)

Last Updated

July 23, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT04236336
Data provider: ClinicalTrials.gov
Source updated: 2024-07-23
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:30:19 UTC

Locations

ES(1)US(4)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (5)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations