<?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>IRCT20201124049483N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-11-27</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of two different treatments in patients with jaw disorders</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of thermotherapy and low power laser treatment in patients with (TMD)Temporo mandibular joint disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-11-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>33</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/52549</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The sampling method is random among the people referring to the maxillofacial surgery department of Tabriz Dental School. The randomization method is simple and the unit is individual. Our tool for randomization is the randomized number chart. Furthermore, the allocation of treatment to patients will be done Randomly. To do this, the types of treatment are identified with code A (diathermy) , B (laser) and C(hot pack ), and then will be placed in sealed envelopes and will be stirred. Then they are randomly taken out of the bag and after observing the code, the treatment will be given to the patient. None of the patients will be informed about another patient's treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Temporomandibular joint disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Laser group: Laser treatment will be performed through a low-power laser device available in Imam Reza Hospital in Tabriz. The patient will be treated for 12 sessions. In this study, a low-power gallium aluminum arsenide GaAlAs METRON laser made in Australia was used using a pen applicator with a cross-sectional area of ​​one centimeter of radiation. The device was calibrated by the engineering company before conducting the research. The specifications of the laser used in this research were as follows: Wavelength = 810 nm Energy density = J / cm2 5 power = mw 100 time = 50 seconds are treated with laser anywhere. We place the probes of the device based on the trigger points and pain places in the desired location. We will place the Red probe on the joint and the INFRARED Scanner on the trigger points in the masticatory muscles. Intervention 2: Intervention group: Diathermy group: We place the electrodes of the device in the points of pain and joint.  To prevent skin burns between the electrode and the body, we use special oils.  The current between the electrodes warms the tissue in the body and induces its therapeutic effects in this way. The patient will be treated for 12 sessions. Intervention 3: Intervention group: Hot Pack Group: By bending the piece inside the hot pack, the liquid inside the bag slowly becomes solid and generates high heat for about 15 minutes.  To reuse the hot pack bag, it should be placed in hot water for about 5 to 10 minutes so that the material inside the bag becomes liquid again, and you can use the bag again whenever you want.  The bag is placed on the spot for ten minutes.The patient will be treated for 12 sessions.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is not more data</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Reza Khorshidi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Floor2, Central Building No.2, Tabriz University of Medical Sciences, Golgasht St.</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614711</zip>
        <telephone>+98 41 3335 7314</telephone>
        <email>dr_khorshidi@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Reza Khorshidi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Floor2, Central Building No.2, Tabriz University of Medical Sciences, Golgasht St.</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614711</zip>
        <telephone>+98 41 3335 7314</telephone>
        <email>dr_khorshidi@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>People with myogenic orofascial pain
Restrict mouth opening
Aratralgic
Difficulty chewing
Patients with pain in the masticatory and joint muscles</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Abnormal skeletal occlusions (class II and class III occlusion)
Systemic disorders that affect the temporomandibular joint
Patients who have received analgesic or anti-stress medications in the past two weeks
Teeth suspected of pulpitis
Children
Pregnant and lactating women
Patients with epilepsy</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>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Laser group: Laser treatment will be performed through a low-power laser device available in Imam Reza Hospital in Tabriz. The patient will be treated for 12 sessions. In this study, a low-power gallium aluminum arsenide GaAlAs METRON laser made in Australia was used using a pen applicator with a cross-sectional area of ​​one centimeter of radiation. The device was calibrated by the engineering company before conducting the research. The specifications of the laser used in this research were as follows: Wavelength = 810 nm Energy density = J / cm2 5 power = mw 100 time = 50 seconds are treated with laser anywhere. We place the probes of the device based on the trigger points and pain places in the desired location. We will place the Red probe on the joint and the INFRARED Scanner on the trigger points in the masticatory muscles.</i_keyword>
      <i_keyword>Intervention group: Diathermy group: We place the electrodes of the device in the points of pain and joint.  To prevent skin burns between the electrode and the body, we use special oils.  The current between the electrodes warms the tissue in the body and induces its therapeutic effects in this way. The patient will be treated for 12 sessions.</i_keyword>
      <i_keyword>Intervention group: Hot Pack Group: By bending the piece inside the hot pack, the liquid inside the bag slowly becomes solid and generates high heat for about 15 minutes.  To reuse the hot pack bag, it should be placed in hot water for about 5 to 10 minutes so that the material inside the bag becomes liquid again, and you can use the bag again whenever you want.  The bag is placed on the spot for ten minutes.The patient will be treated for 12 sessions.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The amount of pain. Timepoint: Before and after the study. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>The amount of mouth opening. Timepoint: Before and after the study. Method of measurement: 10 cm ruler calibrated in millimeters.</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>2020-11-24</approval_date>
        <contact_name>Ethics Committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Floor2, Central Building No.2, Tabriz University of Medical Sciences, Golgasht St. Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
