<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/NCT04456946</url>
  </required_header>
  <id_info>
    <org_study_id>2019/72</org_study_id>
    <secondary_id>34978</secondary_id>
    <secondary_id>2019-190</secondary_id>
    <nct_id>NCT04456946</nct_id>
  </id_info>
  <brief_title>Prospective Investigation of the Effects of Different Treatment Techniques on Myofascial Trigger Points in Patients With Temporomandibular Dysfunction (TMD)</brief_title>
  <official_title>Prospective Investigation of the Effects of Different Treatment Techniques on Myofascial Trigger Points in Patients With Temporomandibular Dysfunction (TMD)</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, there are no studies comparing the use of occlusal splint and Low Level&#xD;
      Laser (LLL) in the treatment of Temporomandibular Disfunction (TMD) and including&#xD;
      Ultrasonography (USG) in these parameters. In this study, it is aimed to contribute to the&#xD;
      literature in terms of determining which treatment method is more effective by evaluating the&#xD;
      changes in the needles muscles with the use of occlusal splints and LLL with USG and other&#xD;
      parameters in certain periods, as well as evaluating which parameters are more effective.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 12, 2022</start_date>
  <completion_date type="Actual">April 1, 2023</completion_date>
  <primary_completion_date type="Actual">April 1, 2023</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Joint Pain Scale</measure>
    <time_frame>2 years</time_frame>
    <description>Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) form will be used in our study</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Low Level Laser and Occlusal Splint</condition>
  <arm_group>
    <arm_group_label>Group of Low Level Laser Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Group of Occlusal Splint Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Low Level Laser Therapy</intervention_name>
    <description>Low Level Laser Therapy</description>
    <arm_group_label>Group of Low Level Laser Therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Occlusal Splint Treatment</intervention_name>
    <description>Occlusal Splint Treatment</description>
    <arm_group_label>Group of Occlusal Splint Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients over the age of 18 who apply with Temporomandibular Joint (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>
  <overall_official>
    <last_name>Ahmet Faruk Erturk, Assistant Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Biruni University</affiliation>
  </overall_official>
  <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 2023</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>April 9, 2023</last_update_submitted>
  <last_update_submitted_qc>April 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 11, 2023</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>Lecturer</investigator_title>
  </responsible_party>
  <keyword>Low Level Laser</keyword>
  <keyword>Occlusal Splint</keyword>
  <keyword>Temporomandibular Disfunction</keyword>
  <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>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Salicylic Acid</mesh_term>
  </intervention_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 26, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/46/NCT04456946/Prot_SAP_001.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 12, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/46/NCT04456946/ICF_000.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/NCT04456946
org study id: 2019/72
secondary id: 34978
secondary id: 2019-190
nct id: NCT04456946
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In the literature, there are no studies comparing the use of occlusal splint and Low Level
      Laser (LLL) in the treatment of Temporomandibular Disfunction (TMD) and including
      Ultrasonography (USG) in these parameters. In this study, it is aimed to contribute to the
      literature in terms of determining which treatment method is more effective by evaluating the
      changes in the needles muscles with the use of occlusal splints and LLL with USG and other
      parameters in certain periods, as well as evaluating which parameters are more effective.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Joint Pain Scale
time frame: 2 years
description: Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) form will be used in our study
arm group label: Group of Low Level Laser Therapy
arm group type: Experimental
arm group label: Group of Occlusal Splint Treatment
arm group type: Experimental
intervention type: Device
intervention name: Low Level Laser Therapy
description: Low Level Laser Therapy
arm group label: Group of Low Level Laser Therapy
intervention type: Device
intervention name: Occlusal Splint Treatment
description: Occlusal Splint Treatment
arm group label: Group of Occlusal Splint Treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ahmet Faruk Erturk, Assistant Professor
role: Principal Investigator
affiliation: Biruni University
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Istanbul University
investigator full name: Ahmet Faruk ERTURK
investigator title: Lecturer
mesh term: Temporomandibular Joint Disorders
mesh term: Temporomandibular Joint Dysfunction Syndrome
mesh term: Salicylic Acid
sharing ipd: Undecided
provided document: 
provided document: 