<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03305315</url>
  </required_header>
  <id_info>
    <org_study_id>ZWETYENGA ENIM 2016</org_study_id>
    <nct_id>NCT03305315</nct_id>
  </id_info>
  <brief_title>Study of Temporomandibular Joint Dysfunction</brief_title>
  <acronym>CinématiqueATM</acronym>
  <official_title>Study of Movement of the Pathological Temporomandibular Joint.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire Dijon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire Dijon</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Given the frequency of temporomandibular joint (TMJ) dysfunction and the variations in its&#xD;
      expression, this project intends to initiate a process of objective evaluation of mandible&#xD;
      function and its impairment due to different diseases. The first step is to determine whether&#xD;
      3D kinematic quantification of the mandible would make it possible to objectively assess the&#xD;
      effect of post-operative management on TMJ function recovery. If the first results are&#xD;
      encouraging and show the sensitivity of the analysis of minor joint dysfunctions, the&#xD;
      investigators will evaluate the feasibility of kinematic assessments for major TMJ&#xD;
      dysfunctions and for the follow-up of patients.&#xD;
&#xD;
      The expected benefits of this study are to be considered in the medium term and concern the&#xD;
      possibilities offered by measuring mandible kinetics in the treatment of TMJ disorders.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 12, 2017</start_date>
  <completion_date type="Actual">November 22, 2019</completion_date>
  <primary_completion_date type="Actual">November 22, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Mobility of the jaw with regard to the skull during each movement.</measure>
    <time_frame>Until 6 months post-surgery</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">15</enrollment>
  <condition>Diseases of the Temporomandibular Joint</condition>
  <arm_group>
    <arm_group_label>Cases</arm_group_label>
    <description>Diseases of the temporomandibular joint</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Controls</arm_group_label>
    <description>Asymptomatic subjects</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Measurements of jaw movement</intervention_name>
    <description>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.</description>
    <arm_group_label>Cases</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Measurement of natural electrical activity of facial muscles</intervention_name>
    <description>Natural electrical activity of the facial muscles will be measured using electrodes placed on the skin.</description>
    <arm_group_label>Cases</arm_group_label>
    <arm_group_label>Controls</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with temporomandibular joint disorders and asymptomatic subjects&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients:&#xD;
&#xD;
          -  Patients who have provided verbal consent,&#xD;
&#xD;
          -  Patients over 18 years old,&#xD;
&#xD;
          -  Patients with mandible dentition compatible with placement of the kinetic measurement&#xD;
             device,&#xD;
&#xD;
          -  Patients with a TMJ disease requiring surgery (irreducible dislocation of the joint&#xD;
             disc, damage to the joint disc requiring discectomy, ankylosis or severe arthritis of&#xD;
             the mandible requiring mandible implants or a TMJ prosthesis).&#xD;
&#xD;
        Asymptomatic subjects:&#xD;
&#xD;
          -  Subjects who have provided verbal consent,&#xD;
&#xD;
          -  Subjects over 18 years old,&#xD;
&#xD;
          -  Subjects with Class 1 occlusion,&#xD;
&#xD;
          -  Subjects without dental implants,&#xD;
&#xD;
          -  Subjects with no history of joint dysfunction,&#xD;
&#xD;
          -  Absence of clicking, popping, or grating sounds during large movements and during&#xD;
             palpation of the TMJ with the mouth slightly open (distance between incisors around 1&#xD;
             cm)&#xD;
&#xD;
          -  Absence of headache,&#xD;
&#xD;
          -  Absence of tinnitus,&#xD;
&#xD;
          -  Kinematic curves around the mean.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Adults under guardianship,&#xD;
&#xD;
          -  Patients without national health insurance cover.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Chu Dijon Bourogne</name>
      <address>
        <city>Dijon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>October 4, 2017</study_first_submitted>
  <study_first_submitted_qc>October 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 9, 2017</study_first_posted>
  <last_update_submitted>January 25, 2021</last_update_submitted>
  <last_update_submitted_qc>January 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03305315
org study id: ZWETYENGA ENIM 2016
nct id: NCT03305315
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Other
time perspective: Prospective
measure: Mobility of the jaw with regard to the skull during each movement.
time frame: Until 6 months post-surgery
arm group label: Cases
description: Diseases of the temporomandibular joint
arm group label: Controls
description: Asymptomatic subjects
intervention type: Other
intervention name: Measurements of jaw movement
description: 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.
arm group label: Cases
intervention type: Other
intervention name: Measurement of natural electrical activity of facial muscles
description: Natural electrical activity of the facial muscles will be measured using electrodes placed on the skin.
arm group label: Cases
arm group label: Controls
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: France
responsible party type: Sponsor