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

August 16, 2010 updated by: Ascentia Health, Inc.

Treatment Outcome of Temporomandibular Disorders Via the Clayton Intra-aural Device (CID): A Randomized Clinical Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
152

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • D.f.
      • Mexico City, D.f., Mexico, 06700
        • Instituto Mexicano de Investigación Clinica

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 1
Treatment group receiving the CID
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").
Active Comparator: 2
Group assigned a mouth splint
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.
Active Comparator: Exercise Control Group
Group who received no device but were instead assigned a study-specified jaw exercise program
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline In Craniomandibular Index (CMI) Scores At 3 Months (In A Scale)
Time Frame: 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
Time Frame: From Baseline through 3 months post-baseline visit.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline In Craniomandibular Index (CMI) Scores At 3 Months (In A Scale)
Time Frame: Change from Baseline in Craniomandibular Index (CMI) Score at Three Months Post-Baseline (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) Score at Three Months Post-Baseline (in a scale)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ascentia Health, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alejandro Tsuchiya, DDS, Insitituto Mexicano de Investigacion Clinica
  • Study Director: Lawrence G. Clayton, M.A., Ascentia Health, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 29, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 29, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 30, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 24, 2010

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 16, 2010

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CID2007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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