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Sponsored by: |
Ascentia Health, Inc. |
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Information provided by: | Ascentia Health, Inc. |
ClinicalTrials.gov Identifier: | NCT00815776 |
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.
Condition | Intervention | Phase |
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Temporomandibular Disorders |
Device: Clayton Intra-aural Device (CID) Device: Mouth Splint Other: Exercise Group |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Treatment Outcome of Temporomandibular Disorders Via the Clayton Intra-Aural Device (CID): A Randomized Clinical Trial |
Enrollment: | 150 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | January 2009 |
Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Treatment group receiving the CID
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Device: Clayton Intra-aural Device (CID)
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").
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2: Active Comparator
Active control group receiving an intra-oral flat-plane splint
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Device: Mouth Splint
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.
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Exercise Control Group: Placebo Comparator
Passive control group, who receive no device but will complete a study-specified exercise program
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Other: Exercise Group
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.
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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 physicial 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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
A subject must meet all of the following criteria to be eligible for study participation:
Subjects must have an RDC/TMD diagnoses that include at least one of the following:
The subject has the presence of one or more of the following findings associated with pain as demonstrated with a VAS score of >4:
Exclusion Criteria:
Mexico, D.F. | |
Instituto Mexicano de Investigacion Clinica | |
Mexico City, D.F., Mexico, 06700 |
Principal Investigator: | Alejandro Tsuchiya, DDS | Insitituto Mexicano de Investigacion Clinica |
Study Director: | Lawrence G. Clayton, M.A. | Ascentia Health, Inc. |
Responsible Party: | Ascentia Health, Inc. ( Lawrence G. Clayton ) |
Study ID Numbers: | CID2007 |
Study First Received: | December 29, 2008 |
Last Updated: | January 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00815776 |
Health Authority: | Mexico: Ministry of Health |
Temporomandibular disorders |
Temporomandibular Joint Disorders Muscular Diseases Alginic acid Musculoskeletal Diseases Temporomandibular Joint Dysfunction Syndrome Myofascial Pain Syndromes |
Fibromyalgia Craniomandibular Disorders Joint Diseases Salicylic Acid Pain Stomatognathic Diseases |
Mandibular Diseases Pathologic Processes Disease Jaw Diseases |