Treatment Outcomes for Temporomandibular Disorders (TMD) Via the Clayton Intra-aural Device (CID) Clinical Trial

Inclusion Criteria

A subject must meet all of the following criteria to be eligible for study participation:

• Subjects who present to IMIC for jaw pain or dysfunction
• Subjects who sign and date an IRB/EC approved informed consent form
• Subjects must have an RDC/TMD diagnoses that include at least one of the following:
• Myofascial Pain
• Arthralgia
• Disc displacement with reduction; AND

The subject has the presence of one or more of the following findings associated with pain as demonstrated with a VAS score of >4:

• Increased (>60mm) or decreased (<40mm) range of interincisal jaw opening;
• Pain upon any jaw movement;
• Pain on digital palpation (about 0.45 kg of pressure) of the periauricular area or external auditory meatal areas;
• Pain on digital palpation (about 0.45 kg of pressure) in 2 or more muscles of mastication; or
• Joint sound with pain

Exclusion Criteria

• Subjects diagnosed with rheumatoid arthritis, osteoarthritis, osteoarthrosis or another connective tissue disorder
• Subjects who have had direct trauma to the jaw
• Subjects who have used an occlusal appliance to treat a TMD within the previous six months
• Subjects who have had prior TMJ or ear surgery
• 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
• 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 taken a narcotic pain medication in the last seven days or who have taken aspirin or a non-steroidal anti-inflammatory agent in the last 24 hours
• Subjects who have a history of ear pain unrelated to TMJ
• Subjects who have a history of ear drainage in the past 2 years
• Subjects who have active ear drainage, swelling, or redness as observed on targeted physical exam
• Subjects whom the investigator believes may not be a appropriate candidates 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)