<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/NCT04453215</url>
  </required_header>
  <id_info>
    <org_study_id>1298</org_study_id>
    <nct_id>NCT04453215</nct_id>
  </id_info>
  <brief_title>Laser Therapy for Patients With Systemic Lupus Erythematosus</brief_title>
  <official_title>The Effect of Dental Laser Therapy for Patients With Systemic Lupus Erythematosus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dr. Merve Benli</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istanbul University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Systemic lupus erythematosus (SLE) is a chronic, autoimmune disease that has detrimental&#xD;
      effects on connective tissue and other organs. The musculoskeletal system is one of the most&#xD;
      affected systems in this group of patients including the temporomandibular joint. The most&#xD;
      common symptoms when muscle involvement in SLE are muscle atrophy decreased muscle strength&#xD;
      and myopathy. SLE activity and long-term corticosteroid use are thought to be responsible for&#xD;
      these symptoms, thus, SLE patients are accepted to be at higher risk for temporomandibular&#xD;
      joint disorders (TMD). Low-level laser therapy(LLLT) is frequently used in the treatment of&#xD;
      TMD due to its pain relief and anti-inflammatory effect. Thus, in this study, LLLT has been&#xD;
      used to evaluate this treatment modality on the chewing function and pain values of SLE&#xD;
      patients with myogenic TMD.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 12, 2019</start_date>
  <completion_date type="Actual">March 15, 2020</completion_date>
  <primary_completion_date type="Actual">December 23, 2019</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 (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>pain value</measure>
    <time_frame>2 months</time_frame>
    <description>Pain intensity was evaluated by using Visual Analog Scale(VAS).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>chewing function</measure>
    <time_frame>2 months</time_frame>
    <description>The chewing function was evaluated by measuring the geometric mean diameter of crushed test food.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">91</enrollment>
  <condition>Systemic Lupus Erythematosus</condition>
  <condition>Muscle Pain</condition>
  <condition>Chewing Function</condition>
  <arm_group>
    <arm_group_label>test group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SLE patients treated with infrared laser irradiation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>SLE patients treated with red laser irradiation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>no therapy group</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>GaAlAs semiconductor diode laser device</intervention_name>
    <description>low-level laser therapy</description>
    <arm_group_label>placebo group</arm_group_label>
    <arm_group_label>test group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Having myogenic temporomandibular joint disorder,&#xD;
&#xD;
          -  Following a stable medical regime,&#xD;
&#xD;
          -  Showing minimum pain intensity of 50 mm on the visual analog scale.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Having concurrent systemic diseases,&#xD;
&#xD;
          -  Using antimalarial drugs,&#xD;
&#xD;
          -  Wearing removable prosthesis,&#xD;
&#xD;
          -  History of facial trauma.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>merve benli, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistant Professor</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Istanbul university,Faculty of Dentistry</name>
      <address>
        <city>Fatih</city>
        <zip>34452</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>June 28, 2020</study_first_submitted>
  <study_first_submitted_qc>June 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>November 2, 2021</last_update_submitted>
  <last_update_submitted_qc>November 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 10, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Istanbul University</investigator_affiliation>
    <investigator_full_name>Dr. Merve Benli</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myalgia</mesh_term>
    <mesh_term>Lupus Erythematosus, Systemic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>When requested by a researcher, the data can be shared without the identity of the patient.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>The data will become available when confirmed, and it will be available for one year.</ipd_time_frame>
    <ipd_access_criteria>The study protocol and patient selection will be shared.</ipd_access_criteria>
  </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/NCT04453215
org study id: 1298
nct id: NCT04453215
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Systemic lupus erythematosus (SLE) is a chronic, autoimmune disease that has detrimental
      effects on connective tissue and other organs. The musculoskeletal system is one of the most
      affected systems in this group of patients including the temporomandibular joint. The most
      common symptoms when muscle involvement in SLE are muscle atrophy decreased muscle strength
      and myopathy. SLE activity and long-term corticosteroid use are thought to be responsible for
      these symptoms, thus, SLE patients are accepted to be at higher risk for temporomandibular
      joint disorders (TMD). Low-level laser therapy(LLLT) is frequently used in the treatment of
      TMD due to its pain relief and anti-inflammatory effect. Thus, in this study, LLLT has been
      used to evaluate this treatment modality on the chewing function and pain values of SLE
      patients with myogenic TMD.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: pain value
time frame: 2 months
description: Pain intensity was evaluated by using Visual Analog Scale(VAS).
measure: chewing function
time frame: 2 months
description: The chewing function was evaluated by measuring the geometric mean diameter of crushed test food.
arm group label: test group
arm group type: Experimental
description: SLE patients treated with infrared laser irradiation
arm group label: placebo group
arm group type: Placebo Comparator
description: SLE patients treated with red laser irradiation
arm group label: control group
arm group type: No Intervention
description: no therapy group
intervention type: Device
intervention name: GaAlAs semiconductor diode laser device
description: low-level laser therapy
arm group label: placebo group
arm group label: test group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: merve benli, PhD
role: Principal Investigator
affiliation: Assistant Professor
facility: 
country: Turkey
responsible party type: Sponsor-Investigator
investigator affiliation: Istanbul University
investigator full name: Dr. Merve Benli
investigator title: Assistant Professor
mesh term: Myalgia
mesh term: Lupus Erythematosus, Systemic
sharing ipd: Yes
ipd description: When requested by a researcher, the data can be shared without the identity of the patient.
ipd info type: Study Protocol
ipd time frame: The data will become available when confirmed, and it will be available for one year.
ipd access criteria: The study protocol and patient selection will be shared.