<?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>IRCT20210928052620N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-12-13</date_registration>
      <primary_sponsor>Birjand University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of The effect of low power laser (LLLT) on complications after mandibular third molars</public_title>
      <acronym></acronym>
      <scientific_title>Determine the effect of low level laser therapy(LLLT) on pain, swelling and trismus after impacted mandibular third molar surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-11-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>38</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/59013</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Randomization description: Simple randomization. Sealed by envelope method. We put the names of the patients in the sealed envelope and by drawing lots, the first half of the patients whose names came out of the envelope were on the right side of their mouths in the intervention group and the second half of the patients were the other way around, Blinding description: In this study,  patients are blind.</study_design>
      <phase>3</phase>
      <hc_freetext>Bilateral surgery of impacted mandibular third molars.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention in this study is the use of low power laser. The type of study is split mouth in such a way that for each patient a laser (intervention) is used for one side of the wisdom tooth and a placebo is used for the opposite side. Our intervention is a low-power arsenide-gallium laser that the surgeon uses immediately after surgery and suturing the surgical site at 5 points with a power density of 52.5 joules for 30 seconds (for each point). Intervention 2: Control group:  In our study, each person is both within the intervention group and the control group. Randomly, one side of each patient's mouth is in the intervention group and the other side is in the control group. Here, a part of the mouth that is in the control group uses a silent laser (placebo) after the surgery (the patient is blind).</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:
Information about the main outcome and patient records can be shared. Informed consent form, clinical study results, study protocol and codes used in the study are fully available.

When:
Access period starts 6 months after the results are published

To whom:
Academic researchers

Conditions:
Changes in initial outcomes cannot be cited in other studies because they are time-dependent. The final results of the study provide a suggestion for more detailed studies with greater scope and longer follow-up.

Where to obtain:
chajiamirmohammad@gamil.com
mohamadi_moghadam@yahoo.com

How to obtain:
Sending the content of the email, including the name of the researcher, the name of the study or the reason for interest, and documents related to the academic researcher, if you see the email, the documents will be sent up to one month later.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>amirmohammad chaji</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pamchal Blvd, No.53</address>
        <city>Burjand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9717411143</zip>
        <telephone>+98 56 3240 6292</telephone>
        <email>chajiamirmohammad@gmail.com</email>
        <affiliation>Birjand University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Amirmohammad chaji</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pamchal Blvd, No.53</address>
        <city>Birjand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9717411143</zip>
        <telephone>+98 56 3240 6292</telephone>
        <email>chajiamirmohammad@gmail.com</email>
        <affiliation>Birjand University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients of both sexes are willingly willing to remove impacted mandibular on both sides.
Patients who have the same position and inclination of the impacted molars on both sides of the mandible.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with any systemic disease
Patients who have been taking corticosteroids for more than 3 months.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></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: The intervention in this study is the use of low power laser. The type of study is split mouth in such a way that for each patient a laser (intervention) is used for one side of the wisdom tooth and a placebo is used for the opposite side. Our intervention is a low-power arsenide-gallium laser that the surgeon uses immediately after surgery and suturing the surgical site at 5 points with a power density of 52.5 joules for 30 seconds (for each point).</i_keyword>
      <i_keyword>Control group:  In our study, each person is both within the intervention group and the control group. Randomly, one side of each patient's mouth is in the intervention group and the other side is in the control group. Here, a part of the mouth that is in the control group uses a silent laser (placebo) after the surgery (the patient is blind).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The primary variable is the amount of pain based on the visual analog system (VAS), which is asked of the patient on a scale of 0 to 10. Timepoint: Days 2 and 7 after surgery. Method of measurement: Use the VAS system to measure pain.</prim_outcome>
      <prim_outcome>Another primary consequence variable is the amount of swelling, which is measured by measuring the distance from the corner of the eye to the angle of the jaw on the same side and the distance from the ear hole to the corner of the lip on the same side using a ruler or meter. Timepoint: Days 2 and 7 after surgery. Method of measurement: Use a meter or ruler to measure inflation.</prim_outcome>
      <prim_outcome>Another primary outcome variable is the amount of trismus, which measures the amount of mouth opening using a ruler or meter. Timepoint: Days 2 and 7 after surgery. Method of measurement: Use a meter or ruler to measure the amount of trismus.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>_. Timepoint: _. Method of measurement: _.</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>Birjand University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-01-09</approval_date>
        <contact_name>ٍEthics committee of Birjand university of medical sciences</contact_name>
        <contact_address>Pamchal Blvd, pamchal 4, No.53 Birjand South Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
