Trials Sponsors Conditions Drugs Pricing

Conditions

Edentulous Jaw

Outcome Measures

Primary Outcomes (1)

Dental implant integration
The integration success measured by lack of mobility
2 years

Secondary Outcomes (1)

Crestal Bone Loss
2 years

Interventions

T3 dental implant systemDevice

This clinical study will evaluate patients being treated with the T3 dental implant to confirm its safety and performance (effect of treatment of edentulism). The patients treated will experience a benefit from treatment of edentulism with the T3 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).

Also known as: T3 platform switched certain parallel walled (BOPS), T3 non-platform switched certain parallel walled (BOSS), T3 with DCD platform switched certain parallel walled (BNPS), T3 with DCD non-platform switched certain parallel walled (BNSS)

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 VolunteersYes

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

Sampling MethodProbability Sample

Study Population

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. Patients who have had prior implants in the treatment site that have failed (in need of revision) are not eligible for inclusion.

You may qualify if:

Patients of either sex and at least 18 years of age.

Sponsors & Collaborators

ZimVie
Industrylead

Study Sites (4)

University of Florida

Gainesville, Florida, 32610, United States

Jersey Shore University Medical Center

Neptune City, New Jersey, 07753, United States

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Dr. Daniel Engler-Hamm

München, 80333, Germany

MeSH Terms

Conditions

Jaw, Edentulous

Condition Hierarchy (Ancestors)

Jaw DiseasesMusculoskeletal DiseasesStomatognathic DiseasesMouth, EdentulousMouth DiseasesTooth Diseases

Study Officials

Hai Bo Wen, PhD
ZimVie
STUDY DIRECTOR

Enrollment

139 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

September 21, 2021

First Posted

September 30, 2021

Study Start

October 20, 2021

Actual (reported)

An Observational Clinical Study of the T3 Dental Implant System

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations