Study of Temporomandibular Joint Dysfunction

NCT ID: NCT03305315

Last Updated: 2021-01-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-12-12
• Study Completion Date: 2019-11-22

Brief 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.

Conditions

Diseases of the Temporomandibular Joint

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Cases

Diseases of the temporomandibular joint

Measurements of jaw movement

Intervention Type: OTHER

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

Intervention Type: OTHER

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

Controls

Asymptomatic subjects

Measurement of natural electrical activity of facial muscles

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chu Dijon Bourogne

Dijon, , France

Countries

France

Other Identifiers

ZWETYENGA ENIM 2016

Identifier Type: -

Identifier Source: org_study_id