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

Status unconfirmed

Conditions studied: Malocclusion

In brief

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.

Key facts

Study ID

NCT03606551

Run by

3M

People needed

78

Starts

2018-06-21

Expected to finish

2022-04-30

Last updated by the study team

2021-02-21

Who can join

Age: 11 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Able to understand and willing to voluntarily sign the consent/assent form(s);
• Willing and able to return to the study facility for scheduled visits and recalls;
• Have permanent dentition including first molars, premolars, canines, and incisors erupted;
• Teeth have sound, non-carious buccal enamel, free from white-spot lesions; and,
• Have good oral hygiene as determined by the orthodontist/dental hygienist.
• For intercept patients only:
• Currently have brackets on their teeth; and,
• Have begun treatment with rectangular archwires; or, who are in their finishing stage of orthodontic treatment (i.e. they have 3 to 4 months of treatment remaining).

You may not qualify if…

• Currently participating in another clinical study.
• Difficulty being compliant with study visits, such as those planning or having extensive travel commitments or who lack transportation.
• Have mental, emotional, or developmental disabilities.
• Have a complex/surgical case.
• Have a deep overbite that would result in their maxillary incisor teeth occluding with the ceramic brackets on the mandibular teeth that cannot be avoided.
• Need essential dental care, i.e., for broken teeth, grossly carious or abscessed teeth.
• Have dental prostheses/implants that will interfere with projected teeth movement.
• Have known allergies to product ingredients (e.g. methacrylate resin materials, nickel, chromium).
• Have a medical or oral condition that, in the investigator's judgement, may compromise the subject's safety or interfere with the conduct and outcome of the study.

Where it is running

• McComb Orthodontics — Culver City, California, United States
• Shults Orthodontics — Wellington, Florida, United States
• Minnesota Orthodontics — Northfield, Minnesota, United States
• Alvetro Orthodontics — Sidney, Ohio, United States
• Simply Smiles — McKinney, Texas, United States

Full record on ClinicalTrials.gov

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