<?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>IRCT20211203053265N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-02-26</date_registration>
      <primary_sponsor>Rasht University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of low level laser therapy on acceleration of anterior teeth movement in the first phase of orthodontic treatment</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of low level laser therapy on acceleration of anterior teeth movement in the first phase of orthodontic treatment among patients referred to orthodontic department of dentistry Faculty</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-04-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>28</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60584</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: To randomize the treatment between the left and right mouth, a block randomization method with 4 blocks will be used (block size: 4, actual list length: 14). Considering the time of entry into the study, group A indicates receiving laser treatment on the right side and group B indicates receiving laser treatment on the left side of the mouth and the other side is considered as control. It is an individual randomization unit. Randomization tool is SAS statistical software version 9.
How to build a randomization sequence:
Block ID, block size, sequence within the block, treatment
for example:
• 1, 4, 1, Group B.
• 1, 4, 2, Group A.
, Blinding description: patients are unaware about the test group because tip of the device will be put on the control side but radiation will not be done.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Anomalies of tooth position.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Central, lateral and canine teeth on one side of the patient are exposed to laser radiation. The laser in this study is a low-power gallium arsenide diode (model THOR LX2) that emits an infrared wave with a wavelength of 810 nm. The radiation is continuous with a power of 200 mW. Laser therapy is repeated on days 3, 7, 14 and every month to achieve complete alignment and leveling of the anterior teeth. Intervention 2: Control group: Central, lateral and canine teeth on the opposite side of the patient. To blind the tip of the laser device is placed on the teeth of this part, but laser radiation is not done.</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:
Evaluation of low level laser therapy on acceleration of anterior teeth movement in the first phase of orthodontic treatment among patients referred to orthodontic department of Guilan dentistry Faculty

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

To whom:
Researchers working in academic institutions

Conditions:
Researchers working in academic institutions

Where to obtain:
gholiniaf@gmail.com

How to obtain:
6 months

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Faeghe Gholinia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Dentistry, Guilan University of Medical Sciences, Ring Fooman, Lacan Road</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4188794755</zip>
        <telephone>+98 13 1326 3622</telephone>
        <email>f.gholinia@gums.ac.ir</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Faeghe Gholinia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Dentistry, Guilan University of Medical Sciences, Ring Fooman, Lacan Road</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4194173774</zip>
        <telephone>+98 13 1326 3622</telephone>
        <email>f.gholinia@gums.ac.ir</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with permanent dentition aged between 15 to 30 years old that need orthodontic treatment.
Little Irregularity Index score between 4 to 8 millimeters
Healthy systemic patients
Good oral hygiene and healthy periodontal status</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>30 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Uncontrolled periodontal problems with bone loss
Gum recession more than 2 millimeters
Smoking
Altered bone metabolism due to disease or drug use
Physical or mental disability
Pregnancy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K07.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>K07.3  Anomalies of tooth position</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: Central, lateral and canine teeth on one side of the patient are exposed to laser radiation. The laser in this study is a low-power gallium arsenide diode (model THOR LX2) that emits an infrared wave with a wavelength of 810 nm. The radiation is continuous with a power of 200 mW. Laser therapy is repeated on days 3, 7, 14 and every month to achieve complete alignment and leveling of the anterior teeth.</i_keyword>
      <i_keyword>Control group: Central, lateral and canine teeth on the opposite side of the patient. To blind the tip of the laser device is placed on the teeth of this part, but laser radiation is not done.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Accelerate tooth movement in orthodontic treatment. Timepoint: At the end of the time the anterior teeth become aligned. Method of measurement: Number of days for the patient's teeth to be aligned.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Reduce pain during orthodontic treatment. Timepoint: After each replacement of the archwire. Normally 3 times during treatment. Method of measurement: After each archwire replacement, each patient's pain is measured on a visual analogue scale 24 hours after the visit.</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>Rasht University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-11-25</approval_date>
        <contact_name>Ethics committee of Guilan University of Medical Sciences</contact_name>
        <contact_address>Ahmadzade Ave, Amini Alley, 107 apartment Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
