<?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>IRCT20120220009086N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-11-17</date_registration>
      <primary_sponsor>Hamedan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of LED 850 nm (intra oral ) on the perception of pain and  speed rate of correction of the crowded Mandibular anterior teeth  : A randomized controlled clinical trial</public_title>
      <acronym></acronym>
      <scientific_title>The effect of LED 850 nm (intra oral ) on the perception of pain and  speed rate of correction of the crowded Mandibular anterior teeth  : A randomized controlled clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-12-31</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/59805</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are divided into two groups of control and LED as a block randomization method.
Determines the order in which people are placed in groups. An envelope is selected and this person is placed in one of these groups, Blinding description: In this research, the person who collects the data, as well as the statistical advisor, are not aware of the allocation of groups, LED  and controls.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Crowding of fully erupted teeth.</hc_freetext>
      <i_freetext>Intervention 1: "Intervention group": All patients in the intervention group who have a fixed orthodontic appliance in their jaws are instructed to turn on the appliance for 5 minutes daily and put it in their mouth. This intraoral LED device is made of diodes with a wavelength of 850 nm, which are located in the area of ​​the mandibular anterior teeth. And the patient turns it on and uses it by pressing a button embedded on the device. It should be noted that this device is delivered to the patient from the first session when the brackets and wires are placed on the anterior teeth of the mandible. These patients are visited on a monthly basis until the anterior crowding  reaches below 1 mm, which is the end of use  the device in this group. Intervention 2: Control group: All patients with fixed orthodontic appliance in the mandible. These patients are not given any LED devices and are treated normally. These patients are visited monthly until the crowding  in the anterior mandibular region reach below 1 mm.</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:
Dental velocity data set can be shared in the light data group compared to the potential control group after unidentifiable individuals

When:
starting 6 months after publication, the data will be available for 20 years

To whom:
the data will be available only for people working in academic institutions

Conditions:
no types of analyses on the documents is allowed

Where to obtain:
the preferred way of communication is via email chrika2020@gmail.com the postal address is, Hamadan dental school, in front of Mardom park, Shahid Fahmideh street, Hamadan telephone number is +98 81 3838 1059 fax number is +98 81 3838 1085 the contact person is yousef ahmadpour

How to obtain:
the requests will be discussed and the data would be available in three months

Comments:
-</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Yousef Ahmadpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>in front of Mardom park, Shahid Fahmideh street, Hamadan</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517838741</zip>
        <telephone>+98 81 3838 1059</telephone>
        <email>chrika2020@gmail.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Yousef Ahmadpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>in front of Mardom park, Shahid Fahmideh street, Hamadan</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517838741</zip>
        <telephone>+98 81 3838 1059</telephone>
        <email>chrika2020@gmail.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with a grade of 2-6 mm with a small irregularity index are screened.</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>30 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>long-term consuming nonsteroidal anti inflammatory drugs a and hormonal supplements
poor periodontal health
Patients will be excluded from the study if the bracket fails and the bracket is not replaced within a week.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M26.31</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Crowding of fully erupted teeth</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>"Intervention group": All patients in the intervention group who have a fixed orthodontic appliance in their jaws are instructed to turn on the appliance for 5 minutes daily and put it in their mouth. This intraoral LED device is made of diodes with a wavelength of 850 nm, which are located in the area of ​​the mandibular anterior teeth. And the patient turns it on and uses it by pressing a button embedded on the device. It should be noted that this device is delivered to the patient from the first session when the brackets and wires are placed on the anterior teeth of the mandible. These patients are visited on a monthly basis until the anterior crowding  reaches below 1 mm, which is the end of use  the device in this group.</i_keyword>
      <i_keyword>Control group: All patients with fixed orthodontic appliance in the mandible. These patients are not given any LED devices and are treated normally. These patients are visited monthly until the crowding  in the anterior mandibular region reach below 1 mm.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Rate of tooth movement. Timepoint: At the beginning and end of the study. Method of measurement: study cast.</prim_outcome>
      <prim_outcome>Pain. Timepoint: two weeks after intervention. Method of measurement: modified McGill questionair.</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>Hamadan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-10-18</approval_date>
        <contact_name>Ethics committee of Hamadan University of Medical Sciences</contact_name>
        <contact_address>in front of Mardom park, Shahid Fahmideh street, Hamadan Hamadan Hamadan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
