<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/NCT04434859</url>
  </required_header>
  <id_info>
    <org_study_id>256-20</org_study_id>
    <nct_id>NCT04434859</nct_id>
  </id_info>
  <brief_title>Temporomandibular Disorders Among Patients With Tinnitus</brief_title>
  <acronym>TMDTIN</acronym>
  <official_title>Incidence of Temporomandibular Disorders Among Patients With Tinnitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tel-Aviv Sourasky Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tel-Aviv Sourasky Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The incidence of temporomandibular disorders will be studied among patients with tinnitus, by&#xD;
      the use of patient's history and physical examination.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The patients with tinnituswill be asked about symptoms related to temporomandibular&#xD;
      disorders, and also will be examined in order to diagnose such disorders.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 1, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Description of temporomandibular disorders in the patient's history</measure>
    <time_frame>1 year</time_frame>
    <description>A questioannaire asking specifically about pain in the tempromandibular joint, headaches, clicks, tempromandibular joint locking and dislocation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Positive findings in the physical examination of the temporomandibular joint and muscles</measure>
    <time_frame>1 year</time_frame>
    <description>The following parameters will be documented: clicks, maximal opening of the mouth, signs of teeth grinding, tenderness on the mastication muscles</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Tinnitus</condition>
  <condition>Temporomandibular Disorder</condition>
  <arm_group>
    <arm_group_label>Patients with tinnitus</arm_group_label>
    <description>Patients (over 18 years old) seen at the medical center due to tinnitus, lasting at least 3 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>No intervention</description>
    <arm_group_label>Patients with tinnitus</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with tinnitus lasting more than 3 months&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Tinnitus lasting more than 3 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Head and Neck Space Occupying Lesion&#xD;
&#xD;
          -  Previous degenerative disease of the temporomandibular koint&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>June 14, 2020</last_update_submitted>
  <last_update_submitted_qc>June 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Temporomandibular Joint Disorders</mesh_term>
    <mesh_term>Temporomandibular Joint Dysfunction Syndrome</mesh_term>
    <mesh_term>Tinnitus</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04434859
org study id: 256-20
nct id: NCT04434859
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The incidence of temporomandibular disorders will be studied among patients with tinnitus, by
      the use of patient's history and physical examination.
The patients with tinnituswill be asked about symptoms related to temporomandibular
      disorders, and also will be examined in order to diagnose such disorders.
observational model: Cohort
time perspective: Prospective
measure: Description of temporomandibular disorders in the patient's history
time frame: 1 year
description: A questioannaire asking specifically about pain in the tempromandibular joint, headaches, clicks, tempromandibular joint locking and dislocation
measure: Positive findings in the physical examination of the temporomandibular joint and muscles
time frame: 1 year
description: The following parameters will be documented: clicks, maximal opening of the mouth, signs of teeth grinding, tenderness on the mastication muscles
arm group label: Patients with tinnitus
description: Patients (over 18 years old) seen at the medical center due to tinnitus, lasting at least 3 months.
intervention type: Other
intervention name: No intervention
description: No intervention
arm group label: Patients with tinnitus
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Temporomandibular Joint Disorders
mesh term: Temporomandibular Joint Dysfunction Syndrome
mesh term: Tinnitus
sharing ipd: No