Temporomandibular DisordersPhase 1/2NCT00815776
Treatment Outcomes for Temporomandibular Disorders (TMD) Via the Clayton Intra-aural Device (CID) Clinical Trial
A Phase 1/2 study testing Clayton Intra-aural Device (CID), Mouth Splint and Exercise Group in people with Temporomandibular Disorders, run by Ascentia Health, Inc. at 1 site in Mexico.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Temporomandibular Disorders
- What is being tested?
- Clayton Intra-aural Device (CID), Mouth Splint and Exercise Group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteMexico
- Study dates
- Apr 2008to Jan 2009
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto Mexicano de Investigacion Clinica
Mexico City, D.f., 06700
About this study
Official title: 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.
Read the 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.
- Conditions
- Temporomandibular Disorders
- Being tested
- Clayton Intra-aural Device (CID), Mouth Splint, Exercise Group
- Keywords
- Temporomandibular disorders
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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").
Mouth SplintDevice
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.
Exercise GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Treatment group receiving the CID Receives: Device: Clayton Intra-aural Device (CID) |
| 2 | Active comparator | Group assigned a mouth splint Receives: Device: Mouth Splint |
| Exercise Control Group | Active comparator | Group who received no device but were instead assigned a study-specified jaw exercise program Receives: Other: Exercise Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
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.
Measured: Change from Baseline in Craniomandibular Index (CMI) Score at Three Months Post-Baseline (in a scale)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2008 (estimated)
- Study startApr 2008
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ascentia Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Alejandro Tsuchiya, DDS, Principal investigator, Insitituto Mexicano de Investigacion ClinicaLawrence G. Clayton, M.A., Study director, Ascentia Health, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00815776
- Sponsor's protocol ID
- CID2007
- Status last verified
- Aug 2010
- First submitted
- 29 Dec 2008
- Last updated
- 24 Aug 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 22916669
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Outcome of Temporomandibular Disorders Via the Clayton Intra-aural Device (CID): A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00815776
- Acronym / sponsor ID
- CID2007
- Conditions
- Temporomandibular Disorders
- Keywords
- Temporomandibular disorders
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Ascentia Health, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 30 Dec 2008 (estimated)
- Results
- Posted 6 Aug 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Clayton Intra-aural Device (CID)Treatment group receiving the CID |
| 2 | Active comparator | Device: Mouth SplintGroup assigned a mouth splint |
| Exercise Control Group | Active comparator | Other: Exercise GroupGroup who received no device but were instead assigned a study-specified jaw exercise program |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- 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:
- 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;
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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"). | Device | 1 |
| Mouth SplintGroup 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. | Device | 2 |
| Exercise GroupSubjects 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. | Other | Exercise Control Group |
Primary outcome
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.
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.
1 secondary outcome
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22916669Tavera 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.
Related trials for Temporomandibular Disorders
Recruiting
Photobiomodulation for Management of Temporomandibular Disorder Pain
Pain Related to TMD
Recruiting
Effects of Vagus Nerve Stimulation on Temporomandibular Disorders.
TMD, Temporomandibular Disorders (TMDs)
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Not yet recruiting
Comparing Dextrose Prolotherapy vs. Sodium Hyaluronic Acid Injections for Jaw Joint Internal Derangement
Temporomandibular Joint Internal Derangement, TMJ-ID
Recruiting
R01_Pilot Jaw Muscle Phenotypes
Chronic TMD Pain, Temporomandibular Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alejandro Tsuchiya, DDS principal investigator
Insitituto Mexicano de Investigacion Clinica
Lawrence G. Clayton, M.A. study director
Ascentia Health, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Clayton Intra-aural Device (CID), Mouth Splint and Exercise Group in people with Temporomandibular Disorders, run by Ascentia Health, Inc. at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Aug 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00815776, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2010.