Status:
COMPLETED
Treatment Outcomes for Temporomandibular Disorders (TMD) Via the Clayton Intra-aural Device (CID) Clinical Trial
Lead Sponsor:
Ascentia Health, Inc.
Conditions:
Temporomandibular Disorders
Eligibility:
All Genders
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to characterize the safety profile and assess the effectiveness of the CID in treating subjects with temporomandibular disorders (TMDs). This study is an open-label, three...
Detailed Description
After providing consent, subjects will be assessed as to whether they meet inclusion criteria for the study. Subjects will complete a 4 week diary to measure TMD symptoms by recording pain levels on a...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT00815776
Start Date
April 1 2008
End Date
January 1 2009
Last Update
August 24 2010
Active Locations (1)
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1
Instituto Mexicano de Investigacion Clinica
Mexico City, D.f., Mexico, 06700