Sponsor study identifier
interventional
152
1 country
1
Study Start
April 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2009
Actual (reported)Study Completion
January 2009
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2009
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2008
Date type not reportedThis date has not been verified as actual or estimated.
December 29, 2008
Actual (reported)December 30, 2008
Actual (reported)January 2009
Actual (reported)January 2009
Actual (reported)August 6, 2010
Actual (reported)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.
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)
Treatment group receiving the CID
Group assigned a mouth splint
Group who received no device but were instead assigned a study-specified jaw exercise program
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").
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.
Instituto Mexicano de Investigacion Clinica
Mexico City, D.f., 06700, Mexico
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.
Alejandro Tsuchiya, DDS
Insitituto Mexicano de Investigacion Clinica
Lawrence G. Clayton, M.A.
Ascentia Health, Inc.
152 participants (actual enrollment reported by the registry).
First Submitted
December 29, 2008
First Posted
December 30, 2008
Study Start
April 2008
Date type not reportedThis date has not been verified as actual or estimated.
The New Serial Treatment of Temporomandibular Disorders
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
January 2009
Actual (reported)Study Completion
January 2009
Actual (reported)Last Updated
August 24, 2010
Results First Posted
August 6, 2010
Record last verified: 2010-08
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Source: ClinicalTrials.gov.
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