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Temporomandibular Joint DisordersDTM-SCORENCT03871608

Validation of a Standardized Tool for Evaluation Function of Patients With TMD

An observational study of Temporomandibular Joint Disorders, run by University Hospital, Montpellier at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Temporo-Mandibular Disorders (TMD) are the reason for consultation on more common in maxillofacial. However, there is no consensus on their care. For a long time, Rehabilitative management of the TMD was content to treat only the symptoms. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Temporomandibular Joint Disorders
What is being tested?
Examination of functional etiologies on DTM Disorders and Assessment of symptoms on DTM Disorders
How many people
150 participants
Where
1 siteFrance
Study dates
15 Nov 2019to Feb 2025
Phase
Observational
Are there results?
None posted in the registry

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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patient with TMD Disorders

Who may be able to join

None listed.

Who cannot join

  • Lack of motivation of the patient
  • Mutation or planned move

Trial locations and contacts

1 site in 1 country.

Stéphanie TRICHOT contact

s-trichot@chu-montpellier.fr

France1 site, 1 recruiting
  • Hôpital Gui de Chauliac

    Montpellier, 34295

    Patrick JAMMET, PH, 4 67 33 89 42 ext. +33, p-jammet@chu-montpellier.fr

    Corinne CAZALS, 4 67 330268 ext. +33, c-cazals@chu-montpellier.fr

    Recruiting

Other trials in France

About this study

Official title: Validation of a Standardized Tool for Evaluation Function of Patients With Temporomandibular Disturbances (DTM) by Physiotherapists

Temporo-Mandibular Disorders (TMD) are the reason for consultation on more common in maxillofacial. However, there is no consensus on their care. For a long time, Rehabilitative management of the TMD was content to treat only the symptoms.

No validated score does not allow to evaluate globally the malfunctions at the origin of the TDM, as well as the symptoms and functional discomfort that result. The creation of such a tool would standardize the physical examination of the physiotherapist.

Read more

This is a functional evaluation scale including 2 subparts: an examination of functional etiologies and an assessment of symptoms. At the same time, a self-questionnaire was created to gather the patient's feelings and evaluate the impact of the TMD on his life daily.

The outcome of this research would be to create a score to track the patient's progress during the reeducation, trying to rate the different factors according to their number and severity. This tool would then make it possible to objectify the impact of rehabilitation treatment on the factors etiological and verify the effectiveness of rehabilitation protocols.

Read the detailed description

Temporo-Mandibular Disorders (TMD) are the reason for consultation on more common in maxillofacial. However, there is no consensus on their care. For a long time, Rehabilitative management of the TMD was content to treat only the symptoms.

No validated score does not allow to evaluate globally the malfunctions at the origin of the TMD, as well as the symptoms and functional discomfort that result. The creation of such a tool would standardize the physical examination of the physiotherapist.

This is a functional evaluation scale including 2 subparts: an examination of functional etiologies and an assessment of symptoms. At the same time, a self-questionnaire was created to gather the patient's feelings and evaluate the impact of the TMD on his life daily.

The outcome of this research would be to create a score to track the patient's progress during the reeducation, trying to rate the different factors according to their number and severity. This tool would then make it possible to objectify the impact of rehabilitation treatment on the factors etiological and verify the effectiveness of rehabilitation protocols.

Existing tools:

Imaging: If MRI has long been used to verify the effectiveness of management, the emphasisthe weak link between MRI results and functional disorders, dethroned this examination for the benefit of clinical examination.

Currently, several scores are validated :

  • Helkimo Index = Craniomandibular Dysfunction Index (CDI): Objectives: This is an epidemiological index, developed in 1974 by Helkimo, to assess the needs of treatment in the population by measuring the severity of the symptoms. It provides a good indication of the severity of the TMD. It is still used today in studies.

Limitations of use: It was not designed to evaluate the effectiveness of a rehabilitative management. This diagnostic test of the TMD makes it possible to classify the patients according to the severity of the symptoms but provides no indication of etiological

  • Craniomandibular Index (CMI): Objectives: This index was created in 1985 by Fricton and Schiffman for use in both studies epidemiological and clinical. It measures the variations of the TMD and can therefore be used in the studies evaluating therapeutic strategies [10]. It is divided into two parts: the DI (dysfunction index) and the PI (Palpation index). Limitations of use: However, following the evolution of the management of the TMD, the CMI score presentssome limits. Indeed, this index lists and evaluates the different symptoms of the patient sodetailed (mandibular kinetics, joint sounds and muscle palpation). But, this score does not take into account the new etiologies, it does not make it possible to evaluate the impact of their rehabilitative treatment on the result.
  • DRC / TMD (Research Diagnostic Criteria for Temporomandibular Disorders): Objectives: In 1992, Dworkin et al. have established diagnostic criteria for research for disorders temporomandibular devices (DRC / TMD) to provide a reliable diagnostic tool. The goal was to develop a set of diagnostic criteria for TMD. It includes 2 axes: an interrogation and a physical examination. This score was translated into French in 2002. This is the only existing score taking into account the impact of TMD on the patient's life (functional impairment in daily life).

Limitations of use: Although it evaluates certain etiologies (psychological factors and bruxism), it neglects however all functional etiologies. Moreover, being very detailed, its implementation is time-consuming and makes it difficult to use in everyday practice.

Psychometric benefits and limitations:

Metric values showed acceptable high reliability (except for diduction). The reliability of the extra-oral palpation is correct or elevated. However, the inter-examiner reliability of the Intraoral palpation is weak. This is partly because the examination includes palpation of the Lateral pterygoid, but this one is inaccessible to palpation according to several studies.

  • Palpation test (Palp-Test): Objectives: This is a palpation index of 20 sites involved in the TMD. The test has the advantage of being fast and only takes a minute to complete.

Limitations of use: The disadvantage of this score is that it is restricted. It does not reflect the totality of the symptomatology of the patient.

This assessment tool presented in the form of a functional review and a self-questionnaire fill the gaps presented in existing scores, by bringing new prospects. In addition to assessing the symptoms of the patient, this tool created takes into account etiologies responsible for the appearance and maintenance of the pathology. The self-questionnaire, to be completed by the patient, allows you to evaluate your feelings in order to highlight the impact of TMD on your daily life.

Being tested
Examination of functional etiologies on DTM Disorders, Assessment of symptoms on DTM Disorders
Keywords
temporomandibular joint disorders, rehabilitation, assessment
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.

  • Examination of functional etiologies on DTM DisordersOther

    Evaluating functional etiologies accessible to rehabilitation, consists of 4 categories (Orofacial dyspraxia, parafunctions, posture, Chewing) and includes 11 items in total

  • Assessment of symptoms on DTM DisordersOther

    Examining the symptoms of the patient, consists of 5 categories (Muscle examination, Areas of cellulalgic infiltrates, Mandibular kinetics, Joint sounds, Thrust)and includes 21 items

Study groups in NCT03871608
Study groupRoleWhat they receive
DTM DisordersPatient with DTM Disorders with Examination of functional etiologies on DTM Disorders and Assessment of symptoms on DTM Disorders
Receives: Other: Examination of functional etiologies on DTM Disorders; Other: Assessment of symptoms on DTM Disorders

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Validation of the assessment tool

    Validate an assessment tool for diagnosis of functional etiologies including oroficial dyspraxia, respiration dyspraxia (oral or combined), labial dyspraxia and lingual dyspraxia (lingual immaturity and swallowing dysfunction)

    Measured: 40 months

  2. Establishment of a symptom score

    Validate an assessment tool to score the evolution of the patient with DTM. It's to evaluate the crackles of the jaw, the pain and the dyskinesia.

    Measured: 40 months

Secondary outcomes (8)
  1. Evaluation of the acceptability of the assessment tool

    The rate of unfilled items will be described, The ceiling and floor effects, The filling time of the 2 parts of the questionnaire, Study of the redundancy between items by the correlation between items

    Measured: 40 months

  2. Evaluation of the Reproducibility inter-observer of the assessment tool

    Evaluating the initial balance sheet will be compared between the 2 independent physiotherapists. The concordance of these 2 assessments will be estimated in order to measure inter-observer reproducibility.

    Measured: 40 months

  3. Evaluation of the Reproducibility intra-observer of the assessment tool

    Compare the 2 assessments of the same physiotherapist at the initial assessment and 7 days after (just before the rehabilitation).

    Measured: 40 months

  4. Internal validity of the scale of the assessment tool

    Assess whether changes in the results obtained with the assessment tool about the evaluation of the symptoms are a real change or are related to the evaluator (intra-examiner assessment)

    Measured: 40 months

  5. External validity of the assessment tool

    Evaluation of the correlation (items and scores) between the assessment tool and the Scale Research Diagnostic Criteria for Temporomandibular Disorders (RDC / TMD) and evaluating the discriminant validity, ability of the scale to distinguish different grades of severity from TMD or different levels of pain and discomfort

    Measured: 40 months

  6. Sensitivity to change of the assessment tool

    Evaluation of the pain by the EVA scale mesured at the initial and final visit and comparison with the symptomatology part of the assessment tool

    Measured: 40 months

  7. Sensitivity to change of the assessment tool

    Evaluation of the functional impairment by the EVA scale mesured at the initial and final visit and comparison with the symptomatology part of the assessment tool

    Measured: 40 months

  8. Sensitivity to change of the assessment tool

    Evaluation of the quality of life by the EVA scale mesured at the initial and final visit and comparison with the symptomatology part of the assessment tool

    Measured: 40 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2019
  2. Study start15 Nov 2019
  3. Primary completionAug 2024 (estimated)
  4. Study completionFeb 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03871608
Sponsor's protocol ID
9865
Acronym
DTM-SCORE
Status last verified
Mar 2023
First submitted
8 Jan 2019
Last updated
28 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Temporomandibular Joint Disorders, run by University Hospital, Montpellier at 1 site in France.

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 0 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 28 Mar 2023. 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 France. 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.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Patrick JAMMET, PH (4 67 33 89 42 ext. +33, p-jammet@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Validation of the assessment tool (time frame: 40 months). 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?
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 28 Mar 2023.

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