CinématiqueATM: Study of Temporomandibular Joint Dysfunction

Sponsor
Centre Hospitalier Universitaire Dijon (Other)
Overall Status
Completed
CT.gov ID
NCT03305315
Collaborator
(none)
15
1
23.3
0.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Measurements of jaw movement
  • Other: Measurement of natural electrical activity of facial muscles

Study Design

Study Type:
Observational
Actual Enrollment :
15 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Study of Movement of the Pathological Temporomandibular Joint.
Actual Study Start Date :
Dec 12, 2017
Actual Primary Completion Date :
Nov 22, 2019
Actual Study Completion Date :
Nov 22, 2019

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Mobility of the jaw with regard to the skull during each movement. [Until 6 months post-surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chu Dijon Bourogne Dijon France

Sponsors and Collaborators

  • Centre Hospitalier Universitaire Dijon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier:
NCT03305315
Other Study ID Numbers:
  • ZWETYENGA ENIM 2016
First Posted:
Oct 9, 2017
Last Update Posted:
Jan 26, 2021
Last Verified:
Jan 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jan 26, 2021