ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of Temporomandibular Joint Dysfunction (CinématiqueATM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03305315
Recruitment Status : Recruiting
First Posted : October 9, 2017
Last Update Posted : February 26, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

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
Diseases of the Temporomandibular Joint Other: Measurements of jaw movement Other: Measurement of natural electrical activity of facial muscles

Study Type : Observational
Estimated Enrollment : 15 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Study of Movement of the Pathological Temporomandibular Joint.
Actual Study Start Date : December 12, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Mobility of the jaw with regard to the skull during each movement. [ Time Frame: Until 6 months post-surgery ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with temporomandibular joint disorders and asymptomatic subjects
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03305315


Contacts
Contact: Narcisse ZWETYENGA 03 80 29 37 57 ext +33 narcisse.zwetyenga@chu-dijon.fr

Locations
France
Chu Dijon Bourogne Recruiting
Dijon, France
Contact: Narcisse ZWETYENGA    03 80 29 37 57 ext +33    narcisse.zwetyenga@chu-dijon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon

Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT03305315     History of Changes
Other Study ID Numbers: ZWETYENGA ENIM 2016
First Posted: October 9, 2017    Key Record Dates
Last Update Posted: February 26, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Musculoskeletal Diseases
Joint Diseases
Muscular Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes