TMJ NextGeneration(TM) Feasibility Study

Completed · Not applicable

Conditions studied: Bruxism

In brief

The study is an open-label, prospective, single-center, non-randomized feasibility study of the Bruxoff(TM) device to identify EMG activity associated with bruxism, and to assess the impact of the TMJ NextGeneration(TM) device upon the occurrence of night-time bruxism events and incidence of migraines and headache in subjects diagnosed with sleep bruxism.

Key facts

Study ID

NCT02257320

Run by

TMJ Health

People needed

10

Starts

2014-11-01

Expected to finish

2015-05-01

Last updated by the study team

2015-06-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subjects at least 18 years of age;
• Subject has had a diagnosis of sleep bruxism;
• Subject has been medically screened and diagnosed by a physician as having headaches and/or migraines;
• Subject is willing to comply with the usage instructions for the Bruxoff device;
• Is able to read and understand the ICF and has voluntarily provided written informed consent.
• Subject is able to open their mouth at least 17 mm to be fitted for the TMJ NextGenerationTM device;
• Male Subjects are willing to have a clean shaven face on the nights that the Bruxoff device will be used;
• Subject agrees that when using the Bruxoff device to keep their cellular phone in another room.

You may not qualify if…

• Subjects with any physical or behavioral disorder, which, in the opinion of the Principal Investigator, may interfere with the use of the device or compliance with the study protocol;
• Subject has any sleep disorder other than bruxism;
• Subjects who have had direct trauma to the jaw;
• Subjects who have had prior TMJ or ear surgery;
• Subjects who have a narrow ear canal or impression of the ear canal, which is prolapsed due to an anatomical shift or failure of the ear canal wall structure, or a canal that does not allow for the ear canal second turn to be identified;
• Subjects with visible or congenital ear deformity as observed on targeted physical exam;
• Subjects whose ear canal anatomy does not allow for fit of the study device;
• Subjects who have a history of ear pain unrelated to TMJ;
• Subjects who have a history of ear drainage in the past 6 months;
• Subjects who have active ear drainage, swelling, or redness as observed on targeted physical exam;
• Subject has experienced chronic pain (not including migraine pain) associated with sleep bruxism or TMD for more than six months;
• Subject has a pacemaker.

Where it is running

• Ear, Nose and Throat Associates of South Florida — Boca Raton, Florida, United States
• Ear, Nose and Throat Associates of South Florida — Boynton Beach, Florida, United States

Full record on ClinicalTrials.gov

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