<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/NCT04452110</url>
  </required_header>
  <id_info>
    <org_study_id>2019/73</org_study_id>
    <secondary_id>34908</secondary_id>
    <secondary_id>2019-188</secondary_id>
    <nct_id>NCT04452110</nct_id>
  </id_info>
  <brief_title>Investigation of the Reliability of Ultrasonography Usage in the Diagnosis of Temporomandibular Joint Diseases</brief_title>
  <official_title>Investigation of the Reliability of Ultrasonography Usage in the Diagnosis of Temporomandibular Joint Diseases: A Prospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istanbul University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istanbul University</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>
      In the literature, temporomandibular joint diseases on the diagnostic value of the use of&#xD;
      ultrasonography in diagnosis studies are lacking. In this study in the diagnosis of&#xD;
      temporomandibular joint diseases revealing the reliability of the use of ultrasonography. It&#xD;
      is aimed to contribute to the literature in terms of.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 21, 2019</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>Joint Pain Scale</measure>
    <time_frame>1 year</time_frame>
    <description>Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) form will be used in our study</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Device Reliability</condition>
  <arm_group>
    <arm_group_label>Group I</arm_group_label>
    <description>In volunteers in Group 1, values obtained using a linear probe will be compared.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group II</arm_group_label>
    <description>In volunteers in Group 2, values obtained using a hockey stick probe will be compared.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Ultrasonography</intervention_name>
    <description>Temporomandibular joint diseases of ultrasonography its effectiveness and reliability in diagnosis disadvantages in MR and other imaging methods be ruled out.</description>
    <arm_group_label>Group I</arm_group_label>
    <arm_group_label>Group II</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients Applying to Our University&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients over the age of 18 who apply with TMJ problems&#xD;
&#xD;
          -  Patients with pain in the joint and chewing muscle area&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Syndromic patients&#xD;
&#xD;
          -  Patients under the age of 18&#xD;
&#xD;
          -  Patients with a history of orthognathic surgery&#xD;
&#xD;
          -  Pregnants&#xD;
&#xD;
          -  Antidepressant Users&#xD;
&#xD;
          -  Patients Using Removable Dentures&#xD;
&#xD;
          -  Patients who have had joint treatment in the past six months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Istanbul University, Dentistry Faculty</name>
      <address>
        <city>Istanbul</city>
        <state>Fatih</state>
        <zip>34200</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>April 8, 2021</last_update_submitted>
  <last_update_submitted_qc>April 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istanbul University</investigator_affiliation>
    <investigator_full_name>Ahmet Faruk ERTURK</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Ultrasonography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Joint Diseases</mesh_term>
    <mesh_term>Temporomandibular Joint Disorders</mesh_term>
    <mesh_term>Temporomandibular Joint Dysfunction Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 9, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/10/NCT04452110/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 9, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/10/NCT04452110/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04452110
org study id: 2019/73
secondary id: 34908
secondary id: 2019-188
nct id: NCT04452110
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In the literature, temporomandibular joint diseases on the diagnostic value of the use of
      ultrasonography in diagnosis studies are lacking. In this study in the diagnosis of
      temporomandibular joint diseases revealing the reliability of the use of ultrasonography. It
      is aimed to contribute to the literature in terms of.
observational model: Cohort
time perspective: Prospective
measure: Joint Pain Scale
time frame: 1 year
description: Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) form will be used in our study
arm group label: Group I
description: In volunteers in Group 1, values obtained using a linear probe will be compared.
arm group label: Group II
description: In volunteers in Group 2, values obtained using a hockey stick probe will be compared.
intervention type: Diagnostic Test
intervention name: Ultrasonography
description: Temporomandibular joint diseases of ultrasonography its effectiveness and reliability in diagnosis disadvantages in MR and other imaging methods be ruled out.
arm group label: Group I
arm group label: Group II
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Istanbul University
investigator full name: Ahmet Faruk ERTURK
investigator title: Principal Investigator
mesh term: Joint Diseases
mesh term: Temporomandibular Joint Disorders
mesh term: Temporomandibular Joint Dysfunction Syndrome
sharing ipd: Undecided
provided document: 
provided document: 