<?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>IRCT20190513043579N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-06-09</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effect of low level laser on sensory disturbances after mandibular orthognatic surgery</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effect of photobiomodulation on neurosensory disturbances after sagittal osteotomy of mandible</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-06-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/39545</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random numbers were generated through computerized block randomization using SPSS software version 23, Blinding description: Patients and doctor who evaluated neurosensory recovery were blinded to the side of laser radiation.</study_design>
      <phase>3</phase>
      <hc_freetext>neurosensory disorder.</hc_freetext>
      <i_freetext>Laser irradiation was applied with a GaAs diode laser (Wiser; Doctor Smile–Lambda Spa, Brendola, Vicenza, Italy) (980 nm wavelength, power of 100 mW, and the energy density of 12 J/cm2). Laser irradiation was maintained within a 0.5 cm2 area. Laser energy was used for 60 sec in each visit.Unilateral extraoral LLL therapy was done one day before the surgery and then on the days 1, 3, 7, 14, 21, and 28 after the surgery. One side of the mandible was considered as the intervention side and the other side was considered as the control side. In the control side, laser probe with a red light was put on the considered area, but device was not activated, so that the patients were blinded to the side radiated by laser. In chin area, radiation was done on 6 points on each side from vermilion border to the lower border vertically and from midline to oral commissure horizontally. Then, radiation was appleid on 6 points in buccal region from oral commissure to lingula with a gentle pressure of laser probe..</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Mehdi Taheri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 8 -no 41 Bozorgian st- Narmak</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1645637179</zip>
        <telephone>+98 989171004971</telephone>
        <email>Hamedta90@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Mehdi Taheri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 8 - no 41 - Bozorgian st -Narmak</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1645637179</zip>
        <telephone>+98 982177821713</telephone>
        <email>Hamedta90@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>no previous facial trauma or inferior alveolar nerve injury
no neurosensory disturbance before surgery
patients underwent osteotomy to correct the maxillofacial deformity
no consumption of analgesic, anticonvulsants and antidepressants medications</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with systemic diseases
patients with bad split or severe bleeding during the surgery
patients with obvious nerve damage during the surgery
patients with neuromuscular disorders
patients’ candidate for genioplasty</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Laser irradiation was applied with a GaAs diode laser (Wiser; Doctor Smile–Lambda Spa, Brendola, Vicenza, Italy) (980 nm wavelength, power of 100 mW, and the energy density of 12 J/cm2). Laser irradiation was maintained within a 0.5 cm2 area. Laser energy was used for 60 sec in each visit.Unilateral extraoral LLL therapy was done one day before the surgery and then on the days 1, 3, 7, 14, 21, and 28 after the surgery. One side of the mandible was considered as the intervention side and the other side was considered as the control side. In the control side, laser probe with a red light was put on the considered area, but device was not activated, so that the patients were blinded to the side radiated by laser. In chin area, radiation was done on 6 points on each side from vermilion border to the lower border vertically and from midline to oral commissure horizontally. Then, radiation was appleid on 6 points in buccal region from oral commissure to lingula with a gentle pressure of laser probe.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Neurosensory recovery. Timepoint: assessment of neurosensory recovery  1 and 30 and 60 days after the surgery. Method of measurement: neurosensory tests.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>General Sense. Timepoint: assessment of General Sense 1 and 30 and 60 days after the surgery. Method of measurement: Visual Analogue Scale.</sec_outcome>
      <sec_outcome>Pain Sensation. Timepoint: assessment of Pain Sensation 1 and 30 and 60 days after the surgery. Method of measurement: Needle gauge 23.</sec_outcome>
      <sec_outcome>Two Point Discrimination. Timepoint: assessment of Two Point Discrimination 1 and 30 and 60 days after the surgery. Method of measurement: surgical compass.</sec_outcome>
      <sec_outcome>Thermal discrimination. Timepoint: assessment of Thermal discrimination 1 and 30 and 60 days after the surgery. Method of measurement: Ethyl chloride spray.</sec_outcome>
      <sec_outcome>Directional discrimination. Timepoint: assessment of directional discrimination 1 and 30 and 60 days after the surgery. Method of measurement: Clinical test by nylon thread.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-04-23</approval_date>
        <contact_name>Ethics committee of Dentistry school, Tehran University of Medical Sciences</contact_name>
        <contact_address>North kargar St. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
