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EXD-959 Orthodontic Brackets and EXD-961 Related Instruments Trial

NCT03606551 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 78

Last updated 2021-02-21

No results posted yet for this study

Summary

The purpose of this study is to assess the performance of the EXD-959 self-ligating ceramic bracket system using EXD 961 instruments in the treatment of orthodontic malocclusion. The information gained in this study and other studies will be used to evaluate the clinical performance of the bracket system during orthodontic treatment and to substantiate marketing claims for the bracket system, open/close instrument and de-bonding instrument.

Conditions

  • Malocclusion

Interventions

DEVICE

EXD-959 Bracket System

EXD-959 Ceramic Self-ligating Brackets are a new type of esthetic ceramic bracket developed by 3M™ Oral Care Solutions. The brackets have a sliding door and are composed of alumina (aluminum oxide) and small amounts of related oxide compounds (glass powder) to give them a clear appearance. A nickel-titanium wire serves as part of the door mechanism and is attached to the bracket using 3M ESPE™ Scotchbond™ Universal Adhesive. The brackets are classified as a Class II medical device. A FDA 510(k) submission of EXD-959 was submitted the first quarter of 2018.

Sponsors & Collaborators

  • 3M

    lead INDUSTRY

Principal Investigators

  • Patricia A Lenton, MA, CCRP · 3M

Eligibility

Min Age
11 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-21
Primary Completion
2021-12-30
Completion
2022-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03606551 on ClinicalTrials.gov