<?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>IRCT20180224038840N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-04-23</date_registration>
      <primary_sponsor>Oroumia University of Medical Sciences</primary_sponsor>
      <public_title>Effect of laser Therapy in Tempromandibular Joint Disorders</public_title>
      <acronym></acronym>
      <scientific_title>Effect of 940 nm Low-level Laser Therapy on Treatment of  Patients with Tempromandibular Joint Disorders</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>34</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/59829</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly divided into two groups A and B, using Microsoft Excel software. In this way, for each new patient, an integer is randomly assigned from 1 to 34, and then in the software, each of these numbers will be randomly entered into one of the groups A or B, Blinding description: Patients، Researcher and Statist are blinded of sample assignment.Patients in both groups will not be aware of the effect of the laser. The Principal Investigator and statist do not know the nature of groups A and B. The examiner in charge of patient care is not aware of the type of patient grouping.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Tempromandibular Joint disorders.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the intervention group, 940 nm laser by Epic X biolase laser device (Ezlase; Biolase Technology, Inc., Irvine, CA, USA) will be used after review and calibration by the manufacturer, in the light and laser clinic, with output power of 300 mW in continuous mode, under dedicated control, With an energy density of 2.5 J / cm2 at detected sensitive points for 20 seconds, 2 times per week, totalling 4 weeks, in direct contact technique to the painful points. Intervention 2: Control group: Control group, In the same way the laser group, will be irradiated with a placebo laser (device with laser off). Patients will not be aware of the type of radiation (device on or off).</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:
34 patients referred to the diagnostic department of Alborz Dental Clinic who have signs and symptoms related to Tempromandibular Joint Disorders will be used in the study.

When:
4 month

To whom:
Researchesr

Conditions:
Confidential

Where to obtain:
Researchers

How to obtain:
Permission from the Ethics Committee

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyyed Amir Seyyedi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Emergency Alley, Resalat Boulevard</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5714783734</zip>
        <telephone>+98 44 3223 4897</telephone>
        <email>seyyediamir@yahoo.com</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyyed Amir Seyyedi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Emergency Alley, Resalat Boulevard</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5719736191</zip>
        <telephone>+98 44 3224 0860</telephone>
        <email>seyyediamir@yahoo.com</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>limited mouth opening or function
presence of pain in masticatory muscles and/or TMJs, either in clenching or in jaw movements (TMD muscular disturbance (class Ia, Ib) or arthralgia (class IIIa).</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>patients who had major systemic disorders
patients who received analgesic or anti-depressant over the last 2 weeks
patients who had any bony abnormalities of the jaws such as arthropathy of the TMJ or rheumatoid arthritis
Patients with psychological illness
patients who received any form of treatment for TMD within the last month
pregnant and feeding patients</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 - Other</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the intervention group, 940 nm laser by Epic X biolase laser device (Ezlase; Biolase Technology, Inc., Irvine, CA, USA) will be used after review and calibration by the manufacturer, in the light and laser clinic, with output power of 300 mW in continuous mode, under dedicated control, With an energy density of 2.5 J / cm2 at detected sensitive points for 20 seconds, 2 times per week, totalling 4 weeks, in direct contact technique to the painful points.</i_keyword>
      <i_keyword>Control group: Control group, In the same way the laser group, will be irradiated with a placebo laser (device with laser off). Patients will not be aware of the type of radiation (device on or off).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The number of pain intensity on visual analogue scale (VAS). Timepoint: Measurement of pain intensity before the intervention, 2 weeks and 4 weeks after the start of the intervention and 1 month after the end of the treatment sessions. Method of measurement: visual analogue scale (VAS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Amount of mouth opening. Timepoint: Measurement of pain intensity before the intervention, 2 weeks and 4 weeks after the start of the intervention and 1 month after the end of the treatment sessions. Method of measurement: Digital ruler.</sec_outcome>
      <sec_outcome>The amount of deviation while opening the mouth. Timepoint: Measurement of pain intensity before the intervention, 2 weeks and 4 weeks after the start of the intervention and 1 month after the end of the treatment sessions. Method of measurement: Observation.</sec_outcome>
      <sec_outcome>Satisfaction with treatment. Timepoint: In the last session of laser treatment. Method of measurement: questionnaire.</sec_outcome>
      <sec_outcome>Click sound. Timepoint: Measurement of pain intensity before the intervention, 2 weeks and 4 weeks after the start of the intervention and 1 month after the end of the treatment sessions. Method of measurement: Hearing.</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>Oroumia University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-11-01</approval_date>
        <contact_name>Ethics committee of Urmia University of Medical Sciences</contact_name>
        <contact_address>Third floor, Jam Doctors Building, Madani Street 2, Urmia West Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
