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

NCT00815776 | Completed Phase 1 Results

• 1 other identifier: CID2007
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

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.

Conditions

Temporomandibular Disorders

Keywords

Temporomandibular disorders

Outcome Measures

Primary Outcomes (2)

• Change From Baseline In Craniomandibular Index (CMI) Scores At 3 Months (In A Scale)

  The Craniomandibular Index (CMI) is designed to provide a basis for evaluating the severity of Temporomandibular Disorder (TMD) signs and symptoms. The assessment involves asking questions related to the condition of Mandibular Movement, TMJ noise, and palpations of the extraoral muscle, neck muscle, TMJ capsule and intraoral muscle. The answers to all of the questions are combined to calculate a score from 0 to 1 in which 0 represents no TMD signs and symptoms and 1 represents the most severe TMD signs and symptoms.

  Change from Baseline in Craniomandibular Index (CMI) Scores at 3 months (in a scale)

• Number of Subjects With Adverse Events

  Subjects were assessed for adverse events from the baseline visit through study completion (3 months post-baseline). Adverse events were categorized by the investigator for severity and relationship to treatment.

  From Baseline through 3 months post-baseline visit.

Secondary Outcomes (1)

• Change From Baseline In Craniomandibular Index (CMI) Scores At 3 Months (In A Scale)

  Change from Baseline in Craniomandibular Index (CMI) Score at Three Months Post-Baseline (in a scale)

Study Arms (3)

1

EXPERIMENTAL

Treatment group receiving the CID

Device: Clayton Intra-aural Device (CID)

2

ACTIVE COMPARATOR

Group assigned a mouth splint

Device: Mouth Splint

Exercise Control Group

ACTIVE COMPARATOR

Group who received no device but were instead assigned a study-specified jaw exercise program

Other: Exercise Group

Interventions

Clayton Intra-aural Device (CID) DEVICE

The CID is a patented small, hollow, ear insert made of medical grade polymers that is custom-fit to each subject's ear. Each subject that is randomized to the CID study group will wear a pair of inserts, one in each ear. (For the purpose of this protocol, the pair of inserts will be referred to as the "CID").

1

Mouth Splint DEVICE

Group 2 subjects will be assigned to the active control device, which is current standard of care therapy. The device is an intraoral flat-planed splint full coverage plastic (hard) orthotic that fits over the occlusal one-third surfaces of the dentition. The appliance is made by taking a standard wax bite registration and is made using the standard technique of taking alginate impressions of the subject's teeth, pouring dental laboratory stone into the impression and processing the acrylic appliance on the stone model. This appliance raises the plane of occlusion and provides complete contact with the opposing dentition.

2

Exercise Group OTHER

Subjects assigned to Group 3 will be asked to track daily compliance with the protocol-specific exercise plan in their 4 week diaries. The exercise plan will consist of the following instructions: subjects will be instructed to open their jaw as far as possible, without pain and hold the jaw in that position for 5 seconds. Subjects will then close their jaw and rest 10 seconds. The exercise should be repeated exactly ten times in a row, with a 10 second rest in between each stretch. Subjects will be advised to apply a warm compress to the jaw area after completing their exercises for 10 minutes.

Exercise Control Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ascentia Health, Inc.: lead

Study Sites (1)

Instituto Mexicano de Investigacion Clinica

Mexico City, D.f., 06700, Mexico

Location

Related Publications (1)

• 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.

  PMID: 22916669 DERIVED

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Lawrence G. Clayton, M.A., Study Director
• Organization: Ascentia Health, Inc.

LGClayton@aol.com

(815) 484-9258

Study Officials

• Alejandro Tsuchiya, DDS

  Insitituto Mexicano de Investigacion Clinica

  PRINCIPAL INVESTIGATOR

• Lawrence G. Clayton, M.A.

  Ascentia Health, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 29, 2008
• First Posted: December 30, 2008
• Study Start: April 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: August 24, 2010
• Results First Posted: August 6, 2010

Record last verified: 2010-08

Locations

ME (1)