Skip to main content
OpenTrials
Completed

NCT Number: NCT03305315

Study of Temporomandibular Joint Dysfunction

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diseases of the Temporomandibular Joint

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Dijon Bourogne

Dijon, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Measurements of jaw movement

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

Other

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

Primary outcomes

  1. Mobility of the jaw with regard to the skull during each movement.

    Time frame: Until 6 months post-surgery

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Official study title

Study of Movement of the Pathological Temporomandibular Joint.

Acronym: CinématiqueATM

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 9, 2017
Registry last updated
Jan 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.