<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20260131068714N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-06-03</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effectiveness of low level laser therapy (LLLT) on the location of radiation to masticatory muscles and Temporomandibular joint  /masticatory and cervical muscles and Temporomandibular joint in the treatment of Temporomandibular disorder patients</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effectiveness of low level laser therapy (LLLT) on the location of radiation to masticatory muscles and Temporomandibular joint /masticatory and cervical muscles and Temporomandibular joint in the treatment of Temporomandibular disorder patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-06-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/89036</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization Method:
"Participants will be assigned to one of the three study groups using simple randomization based on a random number table."
Allocation Concealment:
"To ensure allocation concealment, sequentially numbered, opaque, sealed envelopes will be used. These envelopes will be prepared by an individual not involved in the clinical treatment and will only be opened after the participant’s eligibility is confirmed and their informed consent is obtained, indicating their assigned group (Intervention 1, Intervention 2, or Placebo), Blinding description: This study is designed as a double-blind clinical trial.
Furthermore, the clinical evaluator (the individual responsible for measuring pain scales and maximum mouth opening) will be kept blind to the group assignments. This trained evaluator will conduct all clinical examinations and data collection without knowledge of whether the patient belongs to the intervention groups (masticatory muscles and TMJ / masticatory, cervical muscles and TMJ) or the placebo group, thereby minimizing potential assessment bias.".</study_design>
      <phase>2-3</phase>
      <hc_freetext>temporomandibular disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  Laser irradiation at the location of the upper, middle, lower and temporal master muscles, including anterior points, and laser irradiation at the Temporomandibular joint, including anterior, superior, lateral, posterior  points, and the trapezius muscle. Intervention 2: Intervention group: Laser irradiation at the location of the upper, middle, lower and temporal master muscles, including anterior points, and laser irradiation at the Temporomandibular joint, including anterior, superior, lateral, posterior  points. Intervention 3: Control group: In similar conditions to the laser therapy group, only red light and laser warning sound will be used.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
A portion of the data, including information on key outcomes, needs to be shared

When:
Access period starts 3 months after results are published.

To whom:
It will be available only to researchers working in academic and scientific institutions

Conditions:
Requests for access to data can be made via email

Where to obtain:
Via email: vidabadrooj55@gmail.com

How to obtain:
Depending on the amount of data requested, it will take 6-9 months

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Vida Badrooj</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran, third neyestan Ave,rastvan Ave, number 18</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1944965114</zip>
        <telephone>+98 21 2661 4752</telephone>
        <email>vidabadrooj55@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Vida Badrooj</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran, third neyestan Ave,rastvan Ave, number 18</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1944965114</zip>
        <telephone>+98 21 2661 4752</telephone>
        <email>vidabadrooj55@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 20 and 50 years
diagnosis of TMD based on DC/TMD and RDC/TMD criteria
presence of orofacial pain, clicking or limitation of mandibular movement for more than 3 months</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Recent facial trauma
congenital or developmental jaw disorders
recent facial bone fractures
systemic musculoskeletal diseases
current or previous cancer
skin lesions at laser site
pregnancy
recent TMD treatment within the last month
psychiatric disorders
complete denture wearers
dental or periodontal pain</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M26.60</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Temporomandibular joint disorder, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:  Laser irradiation at the location of the upper, middle, lower and temporal master muscles, including anterior points, and laser irradiation at the Temporomandibular joint, including anterior, superior, lateral, posterior  points, and the trapezius muscle.</i_keyword>
      <i_keyword>Intervention group: Laser irradiation at the location of the upper, middle, lower and temporal master muscles, including anterior points, and laser irradiation at the Temporomandibular joint, including anterior, superior, lateral, posterior  points</i_keyword>
      <i_keyword>Control group: In similar conditions to the laser therapy group, only red light and laser warning sound will be used.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Before the study, immediately after the laser therapy, and approximately 30 days after the completion of the laser therapy. Method of measurement: visual scale analogue.</prim_outcome>
      <prim_outcome>Amount of mandibular movement. Timepoint: Before the study, immediately after the laser therapy, and approximately 30 days after the completion of the laser therapy. Method of measurement: International Association for Dental Research.</prim_outcome>
      <prim_outcome>Maximum mouth opening. Timepoint: Before the study, immediately after the laser therapy, and approximately 30 days after the completion of the laser therapy. Method of measurement: Distance between upper and lower incisors in two assisted and unassisted modes by ruler.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-06-02</approval_date>
        <contact_name>Ethics committee of shahid beheshti University of Medical Sciences</contact_name>
        <contact_address>No 18,Pasdaran,Third Neistan street, Rastovan Street Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
