Study of Temporomandibular Joint Dysfunction

Diseases of the Temporomandibular Joint Clinical Trial

— CinématiqueATM  

Official title:

Study of Movement of the Pathological Temporomandibular Joint.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03305315
• Other study ID #: ZWETYENGA ENIM 2016
• Status: Completed
• Start date: December 12, 2017
• Est. completion date: November 22, 2019

Study information

• Verified date: January 2021
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 22, 2019
• Est. primary completion date: November 22, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diseases of the Temporomandibular Joint

Intervention

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.
• Measurement of natural electrical activity of facial muscles
Natural electrical activity of the facial muscles will be measured using electrodes placed on the skin.

Locations

Country	Name	City	State
France	Chu Dijon Bourogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mobility of the jaw with regard to the skull during each movement.		Until 6 months post-surgery