Study of Temporomandibular Joint Dysfunction (CinématiqueATM)

Study of Movement of the Pathological Temporomandibular Joint.

Given the frequency of temporomandibular joint (TMJ) dysfunction and the variations in its expression, this project intends to initiate a process of objective evaluation of mandible function and its impairment due to different diseases. The first step is to determine whether 3D kinematic quantification of the mandible would make it possible to objectively assess the effect of post-operative management on TMJ function recovery. If the first results are encouraging and show the sensitivity of the analysis of minor joint dysfunctions, the investigators will evaluate the feasibility of kinematic assessments for major TMJ dysfunctions and for the follow-up of patients.

The expected benefits of this study are to be considered in the medium term and concern the possibilities offered by measuring mandible kinetics in the treatment of TMJ disorders.

Study Overview

• Status: Completed
• Conditions: Diseases of the Temporomandibular Joint
• Intervention / Treatment: Other: Measurements of jaw movement; Other: Measurement of natural electrical activity of facial muscles

• Study Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• France
  • Dijon, France
    • Chu Dijon Bourogne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with temporomandibular joint disorders and asymptomatic subjects

Description

Inclusion Criteria:

Patients:

• Patients who have provided verbal consent,
• Patients over 18 years old,
• Patients with mandible dentition compatible with placement of the kinetic measurement device,
• Patients with a TMJ disease requiring surgery (irreducible dislocation of the joint disc, damage to the joint disc requiring discectomy, ankylosis or severe arthritis of the mandible requiring mandible implants or a TMJ prosthesis).

Asymptomatic subjects:

• Subjects who have provided verbal consent,
• Subjects over 18 years old,
• Subjects with Class 1 occlusion,
• Subjects without dental implants,
• Subjects with no history of joint dysfunction,
• Absence of clicking, popping, or grating sounds during large movements and during palpation of the TMJ with the mouth slightly open (distance between incisors around 1 cm)
• Absence of headache,
• Absence of tinnitus,
• Kinematic curves around the mean.

Exclusion Criteria:

• Adults under guardianship,
• Patients without national health insurance cover.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cases; Diseases of the temporomandibular joint	Other: Measurements of jaw movement; Jaw mobility will be measured during simple movements of the mouth (opening the mouth, side-to-side and backwards-and-forwards movement of the jaw). These movements will be measured using a specific apparatus, part of which will be placed on the head like a helmet with the other part placed in the mouth and stuck to the teeth using a dental adhesive. The part in the mouth is specifically designed for this purpose. Measurements using this apparatus will take around 30 minutes.; Other: Measurement of natural electrical activity of facial muscles; Natural electrical activity of the facial muscles will be measured using electrodes placed on the skin.
Controls; Asymptomatic subjects	Other: Measurement of natural electrical activity of facial muscles; Natural electrical activity of the facial muscles will be measured using electrodes placed on the skin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mobility of the jaw with regard to the skull during each movement.	Until 6 months post-surgery

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2017
• Primary Completion (Actual): November 22, 2019
• Study Completion (Actual): November 22, 2019

Study Registration Dates

• First Submitted: October 4, 2017
• First Submitted That Met QC Criteria: October 4, 2017
• First Posted (Actual): October 9, 2017

Study Record Updates

• Last Update Posted (Actual): January 26, 2021
• Last Update Submitted That Met QC Criteria: January 25, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: ZWETYENGA ENIM 2016

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No