Clinical trial NCT00815776: Treatment Outcomes for Temporomandibular Disorders (TMD) Via the Clayton Intra-aural Device (CID) Clinical Trial
Official title: Treatment Outcome of Temporomandibular Disorders Via the Clayton Intra-aural Device (CID): A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Temporomandibular Disorders
Keywords: Temporomandibular disorders
Lead sponsor: Ascentia Health, Inc.
Sponsor class: INDUSTRY
First posted: 2008-12-30
Enrollment: 152
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 arm, randomized, unblinded clinical trial with a pre-treatment screening phase, a baseline visit and a 3 month treatment or exercise phase.

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 Visual Analog Scale (VAS) twice daily. Standardized Research Diagnostic Criteria (RDC) are used to classify types of TMDs. The formal assessment tool is known as the RDC/TMD. It is an empirically-based and operationalized system for diagnosing and classifying RDC/TMD using a biopsychosocial model of disease as a framework. The CMI/TMD(hereafter referred to as the CMI) is designed to provide a basis for evaluating the severity of TMD signs and symptoms. The CMI score is calculated from a dysfunction index (DI) and palpation index (PI). The majority of questions found in the CMI are also included in the RDC/TMD, with the exception of five questions. As part of the baseline medical history, all subjects will be asked the five questions that are included in the RDC/TMD but not included in the CMI. Data from the CMI and the five RDC/TMD questions will be combined in the database and scored according to scoring guidelines for the RDC/TMD in order to diagnose and classify TMDs for all study subjects. Subjects may be categorized in one or more of the three diagnostic groups, including muscle disorders (myofascial pain), arthralgia, and disc displacements with reduction. Subjects will have an examination using the CMI at their screening visit. Subjects who meet inclusion criteria will be randomized to one of three groups: The study device (Clayton Intra-aural Device (CID)) group, the mouth splint group, or the exercise group. Subjects in all groups will return to the clinic for a baseline visit, followed by visits at one month, two months and three months post-baseline to return their completed 4 week VAS diary and to complete follow-up testing. At the baseline visit, subjects will have a targeted physical examination, with results documented by the investigator on the CMI questionnaire. Subjects will complete an in-office VAS score, a Modified SSI questionnaire, and will also complete the TMJ Scale, a questionnaire designed to measure possible improvement using a 10 point scale. At each follow-up visit, each subject will complete questionnaires (including the Modified SSI questionnaire and an in-office VAS score)and will have a targeted physical examination, with results documented by the investigator on the CMI questionnaire. At each follow-up visit, subjects will be issued a new monthly diary to complete for the VAS scores twice daily, (once in the morning before 10:00 a.m. and once before bed) as well as to track their device wearing time or exercise compliance, as applicable. At the three month follow-up visit, subjects will also complete the TMJ Scale. Adverse events will be assessed at each visit.

Eligibility criteria: 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)

Primary outcomes:
measure: Change From Baseline In Craniomandibular Index (CMI) Scores At 3 Months (In A Scale)
timeFrame: Change from Baseline in Craniomandibular Index (CMI) Scores at 3 months (in a scale)
measure: Number of Subjects With Adverse Events
timeFrame: From Baseline through 3 months post-baseline visit.
Secondary outcomes:
measure: Change From Baseline In Craniomandibular Index (CMI) Scores At 3 Months (In A Scale)
timeFrame: Change from Baseline in Craniomandibular Index (CMI) Score at Three Months Post-Baseline (in a scale)
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Instituto Mexicano de Investigacion Clinica
state: D.f.
Study officials:
affiliation: Insitituto Mexicano de Investigacion Clinica
name: Alejandro Tsuchiya, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Ascentia Health, Inc.
name: Lawrence G. Clayton, M.A.
role: STUDY_DIRECTOR
References:
citation: Tavera AT, Montoya MC, Calderon EF, Gorodezky G, Wixtrom RN. Approaching temporomandibular disorders from a new direction: a randomized controlled clinical trial of the TMDes ear system. Cranio. 2012 Jul;30(3):172-82. doi: 10.1179/crn.2012.027.