TMJ-1001 Bruxism Run-In/Pivotal Trial | NCT02269553

NCT02269553

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Cardiox Corporation	INDUSTRY

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TMJ NextGeneration(TM)	Active Comparator	The TMJ NextGeneration(TM) device consists of a pair of small, hollow ear inserts. These ear inserts are custom-fit to each subject's ear canals. They are constructed from methacrylate polymers - the same material as has been used in hearing aids. The devices rest in the outer third of the ear canal and have a small retraction post that allows for removal of the device from the ear. The devices conform to the shape of the individuals' ear canals when the jaw is in the open position and permit full passage of sound into each ear. The device is FDA cleared under a 510(k) with an indication of reducing TMD pain.	Device: TMJ(TM) NextGeneration
Standard Hard TMJD Splint	Active Comparator	The occlusal splint to be used in this study will be a hard, full-arch splint with at least one occlusal contact on each tooth of the opposing arch. Each patient assigned to the occlusal splint treatment group may wear either maxillary or mandibular splints or both, as prescribed by the subject's dentist, during the study. All occlusal splints used in the study will be custom fit to each patient using standard dental processes. All occlusal splints used in the study will be manufactured by Paul O'Neill Dental Lab, Yucaipa , CA, USA using clear ADA approved orthodontic acrylic	Device: Standard Hard TMJD Splint

Name	Type	Description	Arm Group Labels	Other Names
TMJ(TM) NextGeneration	Device	The TMJ NextGeneration(TM) device consists of a pair of small, hollow ear inserts.	TMJ NextGeneration(TM)

Measure	Description	Time Frame
Change from Baseline (CFB) in bruxism episodes per hour of sleep		Baseline and Week 8
CFB in the number of migraine episodes per month		Baseline and Week 8

Measure	Description	Time Frame
CFB in the number of headache episodes per month		Baseline and Week 8
CFB in the in-clinic pain Visual Analogue Scale (VAS) scores		Baseline and Week 8
CFB in the average daily at-home pain VAS scores

Measure	Description	Time Frame
Number of Participants with Adverse Events as a Measure of Safety and Tolerability		Baseline and Week 8

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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.

ID	Term
D002012	Bruxism
D008881	Migraine Disorders
D006261	Headache

ID	Term
D014076	Tooth Diseases
D009057	Stomatognathic Diseases
D006184	Habits
D001519	Behavior