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

NCT03871608 | Unknown

• 1 other identifier: 9865
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Temporomandibular Joint Disorders

Keywords

temporomandibular joint disorders; rehabilitation; assessment

Outcome Measures

Primary Outcomes (2)

• 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)

  40 months

• 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.

  40 months

Secondary Outcomes (8)

• Evaluation of the acceptability of the assessment tool

  40 months

• Evaluation of the Reproducibility inter-observer of the assessment tool

  40 months

• Evaluation of the Reproducibility intra-observer of the assessment tool

  40 months

• Internal validity of the scale of the assessment tool

  40 months

• External validity of the assessment tool

  40 months

Study Arms (1)

DTM Disorders

Patient with DTM Disorders with Examination of functional etiologies on DTM Disorders and Assessment of symptoms on DTM Disorders

Other: Examination of functional etiologies on DTM Disorders; Other: Assessment of symptoms on DTM Disorders

Interventions

Examination of functional etiologies on DTM Disorders OTHER

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

DTM Disorders

Assessment of symptoms on DTM Disorders OTHER

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

DTM Disorders

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with TMD Disorders

You may qualify if:

• Patients consulting for DTM at the CHU of Montpellier within the CMF service
• Results obtained with the Helkimo score: moderate to severe
• Age range: between 18 and 75 years old included
• Collection of informed written consent of the patient
• Affiliation or beneficiary of a social security scheme

You may not qualify if:

• Patient under tutorship or curatorship
• Patient under the protection of justice
• Not included for assessment difficulty:
• Associated disease or disability that can skew assessments
• Diseases causing neurological (facial paralysis) or rheumatic (Spondyloarthritis) ankylosing, rheumatoid arthritis) with consequence on TMJ temporomandibular disturbances appeared following a trauma
• Failure to understand questions or instructions
• Large facial dysmorphoses (ODF treatment or surgery)
• Loss of posterior wedging uncompensated (restoration in odontology)
• Lack of motivation of the patient
• Mutation or planned move

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Hôpital Gui de Chauliac

Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Study Officials

• Patrick JAMMET, PH

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick JAMMET, PH

CONTACT

4 67 33 89 42; p-jammet@chu-montpellier.fr

Stéphanie TRICHOT

CONTACT

s-trichot@chu-montpellier.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2019
• First Posted: March 12, 2019
• Study Start: November 15, 2019
• Primary Completion: August 1, 2024
• Study Completion: February 1, 2025
• Last Updated: March 28, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)