<?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>IRCT20210321050751N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-09-27</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of diode laser with transcranial direct current stimulation(TDCS) in reducing symptoms in patients with temporomandibular disorders (TMD)</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of diode laser with transcranial direct current stimulation(TDCS) in reducing symptoms in patients with temporomandibular disorders (TMD)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>34</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63322</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The design of the study is done before and after (before &amp; after). The samples are randomly divided into two groups of 17 and one group will be treated with laser and the other group with TDCS. In this study, a simple randomization method is used. It is an individual randomization unit and the randomization tool is the use of a random number table.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Temporomandibular joint disorders (TMD).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the laser group, 9 sessions of laser therapy using diode laser ( 980 nm, 100 mW) will be performed during 3 weeks (3 times a week).The diode laser is applied in three areas in the TMJ joint, temporalis muscle and gonial angle with a 90 degree angle in contact with the skin and for 10 seconds at each point in 3 points with a distance of 4 mm. Intervention 2: Intervention group: In the TDCS group, treatment will be performed in 5 sessions for 5 consecutive days.The TDCS device consists of anode and cathode electrodes, which are connected to an energy source that produces direct current (DC). Two electrodes, one positive pole and the other negative pole, are placed on the head through a sponge pad that is moistened with a conductive solution such as washing serum. They take Passing a weak current to the brain between two electrodes, where the current enters the brain from the anode, passes through the tissue and exits from the cathode, creates changes in the brain. The anode pole in this method leads to an increase in excitability and pole Cathode reduces cortical excitability and the duration of stimulation is up to 20 minutes.</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:
After unidentifying ,it is possible to share all variables of patients.

When:
Start the access period 6 months after publishing the results.

To whom:
Researchers working in academic and scientific institutions and valid scientific research journals.

Conditions:
In order to use the documents of this study for other studies and researches to apply the results and efficiency of modern TMD treatments

Where to obtain:
Responsible person in this field :parisa mohsenzade ,email address : p.mzade75tums@gmail.com

How to obtain:
The applicant can send his request to the above- mentioned email address his/her introduction and the reason for the request and receive the information as soon as possible (finally within 7-10 days)

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Parisa Mohsenzade</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Yazd. Dahe fajr Boulevard. Imam Reza Street.Shahid Sadoughi University of Medical Science</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8914881167</zip>
        <telephone>+98 34 3428 4157</telephone>
        <email>p.mzade75tums@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Parisa Mohsenzade</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Yazd. Dahe fajr Boulevard. Imam Reza Street.Shahid Sadoughi University of medical science</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8914881167</zip>
        <telephone>+98 34 3428 4157</telephone>
        <email>p.mzade75tums@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1) Patients 40-18 years old
2) Have vague or obvious pain in the temporomandibular joint for at least 2 months (score 4 or higher on the VAS scale).
3) Have at least one of the following two symptoms.1. Sensitivity to the touch of one or more masticatory muscles2. Mandibular restriction on opening
4) Fill in the informed consent of the patient to enter the study
5) Do not have a history of jaw trauma.
6) Do not have a history of joint disease and rheumatoid arthritis.
7) Do not currently be treated for TMD.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>1. Any illness or trauma that occurs after the start of the study for the samples and affects the rate of TMD symptoms.
2.Taking drugs such as cartilage-building drugs and Nsaid
3.Lack of cooperation in continuing the study to complete the treatment sessions</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>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the laser group, 9 sessions of laser therapy using diode laser ( 980 nm, 100 mW) will be performed during 3 weeks (3 times a week).The diode laser is applied in three areas in the TMJ joint, temporalis muscle and gonial angle with a 90 degree angle in contact with the skin and for 10 seconds at each point in 3 points with a distance of 4 mm.</i_keyword>
      <i_keyword>Intervention group: In the TDCS group, treatment will be performed in 5 sessions for 5 consecutive days.The TDCS device consists of anode and cathode electrodes, which are connected to an energy source that produces direct current (DC). Two electrodes, one positive pole and the other negative pole, are placed on the head through a sponge pad that is moistened with a conductive solution such as washing serum. They take Passing a weak current to the brain between two electrodes, where the current enters the brain from the anode, passes through the tissue and exits from the cathode, creates changes in the brain. The anode pole in this method leads to an increase in excitability and pole Cathode reduces cortical excitability and the duration of stimulation is up to 20 minutes</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain score changes. Timepoint: Before treatment, 1 and 3 months after treatment. Method of measurement: VAS.</prim_outcome>
      <prim_outcome>Masticatory muscle tenderness changes. Timepoint: Before treatment, 1 and 3 months after treatment. Method of measurement: 1،2،3،4.</prim_outcome>
      <prim_outcome>Changes in the range of maximum mouth opening. Timepoint: Before treatment, 1 and 3 months after treatment. Method of measurement: mm.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Patient satisfaction score of treatment. Timepoint: after treatment. Method of measurement: questionnaire, Contains questions about improving function, jaw sounds, sleep disorders, etc. after treatment.</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>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-04-16</approval_date>
        <contact_name>Yazd Shahid Sadoughi University of Medical Science</contact_name>
        <contact_address>Yazd. Dahe fajr Boulevard. Imam Reza Street.Shahid Sadoughi University of Medical Science Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
