<?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>IRCT20251004067495N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-12-05</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effect of low level laser therapy on temporomandibular joint disorders</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effect of low level laser therapy on pain and mouth opening in patients with temporomandibular joint disorders</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-12-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/86600</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Individuals will be randomly assigned to two groups using sealed opaque envelopes. First, 15 cards will be labeled "A" and 15 cards will be labeled "B." Then, a random assignment list will be generated using a random number table. In this way, for the numbers in the table, they will be extracted as two digits. If the number is less than 50, "A" will be assigned, and if it is more than 50, "B" will be assigned. The cards will be placed in opaque envelopes in random order and sealed. The envelopes will be placed in a box. At the start of participant registration, each participant will randomly select an envelope from the box and give it to the researcher in charge of randomization. The person in charge will open the envelopes and record the group assigned to each individual, Blinding description: The study will be double-blind, and the patient and the person assessing the outcomes will not be aware of the groupings, and only the person applying the laser and the person responsible for randomization will be aware of the grouping. Also, the laser device will be turned on in the control group to make its sound, but the laser will not be activated, and since all patients' eyes will be closed to protect them from the laser light, they will not notice whether the laser is active or not.</study_design>
      <phase>3</phase>
      <hc_freetext>Temporomandibular joint disorders.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Supportive treatments for temporomandibular joint disorders including warm compresses, muscle relaxants Methocarbamol 500 mg every 8 hours, Ibuprofen 400 mg every 12 hours, habit modification and stretching exercises, along with laser therapy with a low-level diode laser with a wavelength of 980 nm. Intervention 2: Control group: Supportive treatments for temporomandibular joint disorders including warm compresses, muscle relaxants Methocarbamol 500 mg every 8 hours, Ibuprofen 400 mg every 12 hours, habit modification and stretching exercises, along with inactive laser.</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:
18 months after the publication of the article resulting from the thesis

When:
18 months after the publication of the article resulting from the thesis

To whom:
Public

Conditions:
For therapeutic and research purposes

Where to obtain:
Through email with the project supervisor

How to obtain:
Through email with the project supervisor

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hosein eslami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golgasht</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614776</zip>
        <telephone>+98 41 3336 3298</telephone>
        <email>eslamihosein56@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hosein eslami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golgasht</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614776</zip>
        <telephone>+98 41 3336 3298</telephone>
        <email>eslamihosein56@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Temporomandibular disorders diagnosed by an oral medicine specialist
Having informed consent to participate in the study
Age range: 15–40 years
Vertical mouth opening less than 4 centimeters
Presence of pain or clicking in Temporomandibular joint</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Presence of systemic diseases with a history of cancer, radiotherapy, or chemotherapy
Presence of a mass in the jaw, facial, or neck region
Presence of an active infection in the jaw region
Injury to the inferior alveolar nerve
Cardiac disease, cardiac pacemaker
Rheumatoid arthritis
Pregnancy
Mental health problems, seizure
Depression
Using anticholinergic drugs
Patients unwillingness to participate and lack of cooperation
Use of NSAIDs and analgesics in past 2 weeks</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>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Supportive treatments for temporomandibular joint disorders including warm compresses, muscle relaxants Methocarbamol 500 mg every 8 hours, Ibuprofen 400 mg every 12 hours, habit modification and stretching exercises, along with laser therapy with a low-level diode laser with a wavelength of 980 nm.</i_keyword>
      <i_keyword>Control group: Supportive treatments for temporomandibular joint disorders including warm compresses, muscle relaxants Methocarbamol 500 mg every 8 hours, Ibuprofen 400 mg every 12 hours, habit modification and stretching exercises, along with inactive laser.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The pain level. Timepoint: At the (first, fifth, and tenth) sessions. Method of measurement: It will be assessed using the visual analogue scale, where the most severe and unbearable pain is rated as 10, and complete absence of pain is rated as 0. The measurement will be performed at all three stages while the patient is at rest.</prim_outcome>
      <prim_outcome>Mouth opening level. Timepoint: At the (first, fifth, and tenth) sessions. Method of measurement: Maximum mouth opening will be measured using a ruler. The distance between the incisal edges of the upper and lower centrals will be measured at maximum opening. The measurement of maximum mouth opening will be repeated three times and the average of the results will be recorded.</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-08-10</approval_date>
        <contact_name>Ethics committee of Tabriz university of medical sciences fuculty of dentistry</contact_name>
        <contact_address>Golgasht Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
