Status:
WITHDRAWN
TMJ-1001 Bruxism Run-In/Pivotal Trial
Lead Sponsor:
TMJ Health
Collaborating Sponsors:
Cardiox Corporation
Conditions:
Bruxism
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The study is an open-label, prospective, multi-center, randomized, two treatment parallel, comparison study of the TMJ NextGeneration(TM) and custom-fit occlusal splint in the reduction of nocturnal b...
Detailed Description
The study will be conducted at multiple study centers in the U.S. The study will consist of a screening period lasting up to 5 weeks and a treatment period lasting 8 weeks. Subjects will visit the den...
Eligibility Criteria
Inclusion
- Subject is at least 18 years of age;
- Subject has had a diagnosis of sleep bruxism within the past 30 days;
- Subject is able to read and understand the ICF and has voluntarily provided written informed consent;
- Subject must have a minimum of 26 remaining teeth;
- Subject has recorded more than 50% of screening period diary pain VAS scores ≥40;
- Subject has been medically screened and diagnosed by a physician as having migraines;
- Subject has been prescribed and is using a triptan as a rescue medication for their migraine episodes;
- Subject has recorded ≥ 2 self-diagnosed migraine episodes in the screening diary;
- Subject has an average of ≥ 4 bruxism episodes per hour of sleep based on the screening sleep EMG evaluations;
- Subject is willing to comply with the usage instructions for the Bruxoff (sleep EMG evaluation) device.
- 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.
Exclusion
- 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;
- Subject experiences chronic migraines, \> 15 per month;
- Subject experiences secondary headaches (i.e. Arnold-Chiari syndrome and/or low pressure headaches) in the opinion of the Investigator;
- Subjects who have used an occlusal appliance to treat TMD within the previous six months;
- 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 that does not allow for fitting of the study device;
- Subjects who have taken a narcotic pain medication in the last seven days prior to Day -7 of the study;
- Subjects who have a history of ear pain unrelated to TMJ;
- Subjects who have a history of ear drainage in the past six months;
- Subjects who have active ear drainage, swelling, or redness as observed on targeted physical exam;
- Subjects whom the investigator believes may not be an appropriate candidate for an intra-oral splint due to missing or poor quality dentition or untreated pain of dental origin (pulpal pain, pericoronitis of wisdom teeth, or similar conditions);
- Subjects who, in the opinion of the investigator, cannot be properly fit with their assigned device;
- Subject has experienced chronic pain (not including migraine pain) associated with sleep bruxism or TMD for more than six months;
- Subject has a pacemaker.
- Subject has an allergy to polyethylene, dicumyl peroxide, azodicarbonamide, or ammonia.
Key Trial Info
Start Date :
April 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02269553
Start Date
April 1 2015
End Date
December 1 2015
Last Update
May 14 2015
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