<?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>IRCT20180826040872N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-03-03</date_registration>
      <primary_sponsor>Rasht University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of effect of Laser in reducing symptoms of the Mandibular Wisdom tooth surgery</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effectiveness of Low Level Laser Therapy (LLLT) in reducing symptoms after the surgery of the Mandibular Wisdom Tooth</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/33716</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is performed by using R software by statistician and based on that Wisdom Tooth of one side ( as surgical field ) randomly will be placed in placebo group and the other side will be placed in Laser group, Blinding description: The first therapist ( surgeon ) will perform all surgerys and the second therapist after surgery will do Laser Therapy  for Laser group and for placebo group he will put the handpiece  on the field as it is off. The second therapist  will inform the analyst about both groups receiving Laser or not ( without knowledge of patients, first and third therapists ). The third therapist will measure the variables.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: trismus after the Mandibular Wisdom Tooth surgery. Condition 2: extraction of mandibular wisdom tooth.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group ( Laser group ): receiving Low Level Laser with 810 nm wavelength after the Mandibular Wisdom Tooth surgery. Intervention 2: Control group ( placebo group ): receiving placebo treatment ( The handpiece is placed on the field of surgery but the appliance is 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:
All data relative to measured index (pain, edema and trismus ) are shared after unidentifying patients.

When:
6 months or 1 year after the publication of final results

To whom:
Anyone can access the data

Conditions:
In order to design and perform similar research or as a base for more development studys

Where to obtain:
Donya Maleki: donyamaleki93@gmail.com
Dr Sigaroodi: Ali.khaligsigaroodi@gmail.ac.ir

How to obtain:
After sending an email and explaining about the study, they will receive the data in a month.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Donya maleki</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Fuman-Saravan ring road, GUMS complex</address>
        <city>rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4188794755</zip>
        <telephone>+98 13 3348 6406</telephone>
        <email>donyamaleki93@gmail.com</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Ali Khaligh Sigaroodi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Fuman-Saravan ring road, GUMS complex</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4188794755</zip>
        <telephone>+98 13 3348 6406</telephone>
        <email>dental@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 ASA 1
Patients with same level of Mandibular Third Molar in term of Pell &amp; Gregory and Winter category
Patients with good oral health without oral infection
No alcoholic and smoker patients
Patients under 40 years old
Patients referred only for Wisdom Tooth Surgery</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with ASA 2 and more
Patients with acute Pericoronitis in past month
Patients with chronic pain and Mental and Neurological illnesses
Patients under Corticosteroid Therapy
Patients with severe Periodental disease
Patients with Pathology relative to adjacent tooth
Patients with Allergy to local anesthesias or prescribed medicines in study
Patients under treatment with Analgesic and Anti-inflammatory  drugs
In the cases of Laser Therapy contraception in patients
Pregnant and breast feeding patients
Patients who used Antibiotics or Analgesic other than determined protocol before surgery</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R25.2</hc_code>
      <hc_code>K01.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cramp and spasm</hc_keyword>
      <hc_keyword>Impacted 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 ( Laser group ): receiving Low Level Laser with 810 nm wavelength after the Mandibular Wisdom Tooth surgery</i_keyword>
      <i_keyword>Control group ( placebo group ): receiving placebo treatment ( The handpiece is placed on the field of surgery but the appliance is off. )</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Score of pain in Baker Wong faces scale. Timepoint: Measurement of pain every 2 hours up to 6 hours after surgery and then once in the morning and once in the night before sleeping up to three days ( at a specified hour ). Method of measurement: Baker Wong faces scale.</prim_outcome>
      <prim_outcome>Trismus and opening rate of patient's mouth. Timepoint: Evaluation of trismus before surgery, first and seventh day after surgery. Method of measurement: The interval between right Maxillary and Mandibular Central Teeth will be measured by ruler ( centimeter ).</prim_outcome>
      <prim_outcome>Edema. Timepoint: Edema will be measured  before surgery, first and seventh day after surgery. Method of measurement: 5 points are used: the Tragus, the Labial Commissure, the Lateral Canthus of eye, the Gonion and the pogonion. By using a piece yarn the intervals of Tragus to Labial Commissure, Lateral Canthus of eye to Gonion and Tragus to pogonion are measured and will be specified by rules ( centimeter ).</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>Rasht University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-01-12</approval_date>
        <contact_name>Ethics committee of guilan university of medical sciences</contact_name>
        <contact_address>Fuman_Saravan ring road, GUMS complex, dentistry faculty rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
