TMJ-1001 Bruxism Run-In/Pivotal Trial

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 bruxism episodes and monthly migraine episodes in subjects diagnosed with sleep bruxism and headaches.

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 dental clinic twice during the screening period, at Day 1, and at Weeks 4 and 8 of the study.The study will include a single-center run-in phase during which 12 subjects will be enrolled in order to gain preliminary effectiveness data on the TMJ NextGeneration(TM) device. Following completion of the first 12 subjects, a sample size re-estimation may be conducted in order to verify the initial sample size assumptions of the study. These run-in subjects will not be included in the final analysis of the study. Approximately a total of 153 subjects will be enrolled in the study with subjects allocated 2:1 to the TMJ NextGeneration(TM) and occlusal splint treatment arms, respectively. The study is powered with respect to the dual primary effectiveness endpoints of CFB in bruxism episodes per hour of sleep and CFB in migraine episodes per month.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is at least 18 years of age;
2. Subject has had a diagnosis of sleep bruxism within the past 30 days;
3. Subject is able to read and understand the ICF and has voluntarily provided written informed consent;
4. Subject must have a minimum of 26 remaining teeth;
5. Subject has recorded more than 50% of screening period diary pain VAS scores ≥40;
6. Subject has been medically screened and diagnosed by a physician as having migraines;
7. Subject has been prescribed and is using a triptan as a rescue medication for their migraine episodes;
8. Subject has recorded ≥ 2 self-diagnosed migraine episodes in the screening diary;
9. Subject has an average of ≥ 4 bruxism episodes per hour of sleep based on the screening sleep EMG evaluations;
10. Subject is willing to comply with the usage instructions for the Bruxoff (sleep EMG evaluation) device.
11. Subject is able to open their mouth at least 17 mm to be fitted for the TMJ NextGenerationTM device.
12. Male Subjects are willing to have a clean shaven face on the nights that the Bruxoff device will be used;
13. Subject agrees that when using the Bruxoff device to keep their cellular phone in another room.

Exclusion Criteria:

1. 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;
2. Subject has any sleep disorder other than bruxism;
3. Subjects who have had direct trauma to the jaw;
4. Subject experiences chronic migraines, \> 15 per month;
5. Subject experiences secondary headaches (i.e. Arnold-Chiari syndrome and/or low pressure headaches) in the opinion of the Investigator;
6. Subjects who have used an occlusal appliance to treat TMD within the previous six months;
7. Subjects who have had prior TMJ or ear surgery;
8. 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;
9. Subjects with visible or congenital ear deformity as observed on targeted physical exam that does not allow for fitting of the study device;
10. Subjects who have taken a narcotic pain medication in the last seven days prior to Day -7 of the study;
11. Subjects who have a history of ear pain unrelated to TMJ;
12. Subjects who have a history of ear drainage in the past six months;
13. Subjects who have active ear drainage, swelling, or redness as observed on targeted physical exam;
14. 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);
15. Subjects who, in the opinion of the investigator, cannot be properly fit with their assigned device;
16. Subject has experienced chronic pain (not including migraine pain) associated with sleep bruxism or TMD for more than six months;
17. Subject has a pacemaker.
18. Subject has an allergy to polyethylene, dicumyl peroxide, azodicarbonamide, or ammonia.