<?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>IRCT20220613055160N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-07-11</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Using Low Level Laser in The Treatment of The TMD 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 TMJ Masticatory Muscles in the Treatment of TMD Patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64160</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The Rand Function of Excel Software was used for Randomization. The Allocation of Patients to 3 Treatment Groups is done in the form of Randomized Blocks. So that 5 Blocks of 6 are defined, and in Each of These Blocks, the Order of Treatments is generated randomly with the Excel Program. Patients receive Random Treatment in These Randomized Blocks in the Order of Referral.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Temporomandibular disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group 1: 300mW Diode Laser Irradiation for 10 Seconds Bilaterally in the Upper, Middle and Lower Points of the Masseter Muscle; the Anterior Temporal Muscle and the Sternocleidomastoid Muscle. Intervention 2: Intervention Group 2: 300mW Diode Laser Irradiation for 10 Seconds Bilaterally in the Upper, Middle and Lower Points of the Masseter Muscle; the Anterior Temporal Muscle; the Sternocleidomastoid Muscle and the Superior, Inferior, Anterior and Posterior Points of the TMJ. Intervention 3: Control group: In the Similar Conditions  to the Laser Treatment 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:
All Patient's Data Including Age, Sex and results
Research will be Shareable After Making Individuals Undistinguishable.

When:
At the Same Time as Publishing Results

To whom:
Researchers in Academic and Scientific Institutions

Conditions:
Quantitative Analyzes on the Results are allowed

Where to obtain:
Leili Habibi. 0098 9122512396. hiyam1365@yahoo.com

How to obtain:
After Receiving E-mail from Applicant, it will Take up to one Month to send Documents.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sara Tavakolizade</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti Dental School; Shahid Beheshti University of Medical Sciences; Evin Blvd.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1983969411</zip>
        <telephone>+98 21 2990 2302</telephone>
        <email>saratavakolizadeh@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sara Tavakolizade</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti Dental School; Shahid Beheshti University of Medical Sciences; Evin Blvd.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1983969411</zip>
        <telephone>+98 21 2990 2302</telephone>
        <email>saratavakolizadeh@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 / TMJ criteria) 
Click problems, limitation in maximum mouth opening and chronic orofacial pain more than three months</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of Recent Trauma to The Face
Congenital or Developmental Disorders of The Jaw
History of Recent facial Bone Fractures
History or Presence of Systemic Musculoskeletal Diseases
History or Current Cancer
History or Presence of Skin Lesions at The Laser Site
Pregnancy
History of Previous TMD Treatment
History or Presence of Mental Disorders
Complete Dentures Patients
Presence of Toothache or Periodontal Lesions</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M26.6</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Temporomandibular joint disorders</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention Group 1: 300mW Diode Laser Irradiation for 10 Seconds Bilaterally in the Upper, Middle and Lower Points of the Masseter Muscle; the Anterior Temporal Muscle and the Sternocleidomastoid Muscle</i_keyword>
      <i_keyword>Intervention Group 2: 300mW Diode Laser Irradiation for 10 Seconds Bilaterally in the Upper, Middle and Lower Points of the Masseter Muscle; the Anterior Temporal Muscle; the Sternocleidomastoid Muscle and the Superior, Inferior, Anterior and Posterior Points of the TMJ.</i_keyword>
      <i_keyword>Control group: In the Similar Conditions  to the Laser Treatment Group, only Red Light and Laser Warning Sound will be used</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Intensity of spontaneous pain. Timepoint: Spontaneous Pain Measurement before the Study, 30 Days after the Completion of the Laser Therapy Period; 30 and 90 Days after Using the Digital Occlusal Splint. Method of measurement: Visual Analogue Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pain Intensity During function. Timepoint: Measurement of Pain During Function before the Study, 30 Days after the Completion of the Laser Treatment Period; 30 and 90 Days after Using Digital Occlusal Splint. Method of measurement: Visual Analogue Scale.</sec_outcome>
      <sec_outcome>Maximum Mouth Opening. Timepoint: Measurement of the Maximum Mouth Opening before the Study, 30 Days after the Completion of the Laser Treatment Period; 30 and 90 Days after Using Digital Occlusal Splint. Method of measurement: Using a Ruler in millimeter Scale.</sec_outcome>
      <sec_outcome>Mandibular Lateral Movements. Timepoint: Measurement of the Mandibular Lateral Movement before the Study, 30 Days after the Completion of the Laser Treatment Period; 30 and 90 Days after Using Digital Occlusal Splint. Method of measurement: Using a Periodontal Probe in millimeter scale.</sec_outcome>
      <sec_outcome>Mandibular Protrusive Movement. Timepoint: Measurement of the Mandibular Protrusive Movement before the Study; 30 Days after the Completion of the Laser Treatment Period; 30 and 90 Days after Using Digital Occlusal Splint. Method of measurement: Using a Periodontal Probe in millimeter Scale.</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>2022-07-02</approval_date>
        <contact_name>Ethics Committee of Research of Dental School of Shahid Beheshti University of Medical Science</contact_name>
        <contact_address>Shahid Beheshti Dental School; Shahid Beheshti University of Medical Sciences; Evin Blvd. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
