Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT03871608 |
| Other study ID # |
9865 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 15, 2019 |
| Est. completion date |
February 2025 |
Study information
| Verified date |
March 2023 |
| Source |
University Hospital, Montpellier |
| Contact |
Patrick JAMMET, PH |
| Phone |
4 67 33 89 42 |
| Email |
p-jammet[@]chu-montpellier.fr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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.
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.
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.
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.
