xml: <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/NCT06013059</url>
    </required_header>
    <id_info>
      <org_study_id>001056 - IORG 0008839</org_study_id>
      <nct_id>NCT06013059</nct_id>
    </id_info>
    <brief_title>A COMPARATIVE STUDY BETWEEN THE DIFFERENT LEVELS OF TMJ ARTHROSCOPY IN THE MANAGEMENT OF TMJ INTERNAL DERANGEMENT (A RANDOMIZED CLINICAL TRIAL)</brief_title>
    <official_title>A COMPARATIVE STUDY BETWEEN THE DIFFERENT LEVELS OF TMJ ARTHROSCOPY IN THE MANAGEMENT OF TMJ INTERNAL DERANGEMENT (A RANDOMIZED CLINICAL TRIAL)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Alexandria University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Alexandria University</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>
        The temporomandibular joint (TMJ) arthroscopy has emerging role nowadays in the treatment of&#xD;
        TMJ internal derangement with its three levels of intervention. A comparative study between&#xD;
        the 3 levels is essential to develop a standardized selection criteria and management&#xD;
        algorithm.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">June 1, 2021</start_date>
    <completion_date type="Actual">July 30, 2023</completion_date>
    <primary_completion_date type="Actual">December 1, 2022</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Mouth opening measurement</measure>
      <time_frame>1, 3 and 6 months postoperatively</time_frame>
      <description>measuring the maximal interincisal opening (MIO)</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Actual">30</enrollment>
    <condition>TMJ Disc Disorder</condition>
    <arm_group>
      <arm_group_label>level (I) arthroscopy (Lysis and lavage)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>level (II) arthroscopy (operative arthroscopy)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>level (III) arthroscopy (operative arthroscopy + disc repositioning and fixation)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>three levels of TMJ arthroscopy</intervention_name>
      <description>Group I: 10 patients will be treated with Lysis and lavage</description>
      <arm_group_label>level (I) arthroscopy (Lysis and lavage)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>three levels of TMJ arthroscopy</intervention_name>
      <description>Group II: 10 patients will be treated with operative arthroscopy</description>
      <arm_group_label>level (II) arthroscopy (operative arthroscopy)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>three levels of TMJ arthroscopy</intervention_name>
      <description>Group III: 10 patients will be treated with operative arthroscopy + discopexy</description>
      <arm_group_label>level (III) arthroscopy (operative arthroscopy + disc repositioning and fixation)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with TMJ internal derangement Wilkes III&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Medically unfit patients.&#xD;
  &#xD;
            2. Patients with TMDs secondary to malocclusion.&#xD;
  &#xD;
            3. Psychological instability.&#xD;
  &#xD;
            4. Patients operated before for other TMJ problems.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Mohamed Fayad, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Alexandria University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Alexandria University</name>
        <address>
          <city>Alexandria</city>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Alexandria University</investigator_affiliation>
      <investigator_full_name>Mohamed Hamza Fayad</investigator_full_name>
      <investigator_title>Assistant lecturer</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol, Statistical Analysis Plan, and Informed Consent Form</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>Yes</document_has_icf>
        <document_has_sap>Yes</document_has_sap>
        <document_date>February 2, 2022</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/59/NCT06013059/Prot_SAP_ICF_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06013059
  org study id: 001056 - IORG 0008839
  nct id: NCT06013059
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The temporomandibular joint (TMJ) arthroscopy has emerging role nowadays in the treatment of
        TMJ internal derangement with its three levels of intervention. A comparative study between
        the 3 levels is essential to develop a standardized selection criteria and management
        algorithm.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: Mouth opening measurement
  time frame: 1, 3 and 6 months postoperatively
  description: measuring the maximal interincisal opening (MIO)
  arm group label: level (I) arthroscopy (Lysis and lavage)
  arm group type: Active Comparator
  arm group label: level (II) arthroscopy (operative arthroscopy)
  arm group type: Active Comparator
  arm group label: level (III) arthroscopy (operative arthroscopy + disc repositioning and fixation)
  arm group type: Active Comparator
  intervention type: Procedure
  intervention name: three levels of TMJ arthroscopy
  description: Group I: 10 patients will be treated with Lysis and lavage
  arm group label: level (I) arthroscopy (Lysis and lavage)
  intervention type: Procedure
  intervention name: three levels of TMJ arthroscopy
  description: Group II: 10 patients will be treated with operative arthroscopy
  arm group label: level (II) arthroscopy (operative arthroscopy)
  intervention type: Procedure
  intervention name: three levels of TMJ arthroscopy
  description: Group III: 10 patients will be treated with operative arthroscopy + discopexy
  arm group label: level (III) arthroscopy (operative arthroscopy + disc repositioning and fixation)
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Mohamed Fayad, MD
  role: Principal Investigator
  affiliation: Alexandria University
  facility: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Alexandria University
  investigator full name: Mohamed Hamza Fayad
  investigator title: Assistant lecturer
  sharing ipd: No
  provided document: 