<?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>IRCT20190505043481N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-09-20</date_registration>
      <primary_sponsor>Artesh University of Medical Sciences</primary_sponsor>
      <public_title>The effect of laser therapy on lip and chin sensation</public_title>
      <acronym></acronym>
      <scientific_title>The effect of photobiomodulation on neurosensory recovery of patients with neurotmesis of inferior alveolar nerve due to mandibular traumatic fracture</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-03-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>52</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/56232</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Computer software: Randomizer (Version 4.0), Blinding description: Patients, outcome assessor, and analyzer will be blind. Laser therapy will be performed for the intervention group while the laser probe will be placed on the area of the control group turned off. Due to the invisibility of the laser beam and the silence of the probe when turned on, patients will not notice whether the device is turned on or off. The outcome assessor will also evaluate patients in a separate room and will be blind to the patient group. The analyzer will also be blind to the group of patients because the names of the groups will not be in the data.</study_design>
      <phase>N/A</phase>
      <hc_freetext>chin and lip anesthesia due to mandibular trauma.</hc_freetext>
      <i_freetext>Intervention group: Patients who receive laser therapy on the area with neurosensory impairment in12 sessions with Gallium Aluminum Arsenide diode laser. Control group: Patients who do not receive any intervention and the laser probe will be placed on the area with neurosensory impairment turned off for 12 sessions.</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 collected deidentified IPD

When:
starting after publication for 6 months

To whom:
for people working in academic institutions

Conditions:
there are no specific criteria

Where to obtain:
With an email to corresponding author

How to obtain:
The accepted proposal from an official committee should be provided and only if our data was relevant to the proposal needs, the data will be sent

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nariman Nikparto</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>AJA University of Medical Sciences, Etemadzadeh St. , West Fatemi st. , Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411718541</zip>
        <telephone>+98 21 8888 7409</telephone>
        <email>nnikparto@gmail.com</email>
        <affiliation>Artesh University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Behzad Salari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Dentistry of Artesh University of Medical Sciences, Misagh Complex, End of 13th East St. , Ajodania, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411718541</zip>
        <telephone>021228998983</telephone>
        <email>Behzad.salari@gmail.com</email>
        <affiliation>Artesh University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with a history of displaced fractures of the mandibular body, angle, or ramus
Displacement of fracture segments in panoramic radiograph should delineate complete nerve severance (Sunderland 5)
Patients who have received ideal treatment of open reduction and internal fixation
At least six months have elapsed since open reduction and internal fixation treatment, and the neurosensory disorder persists.
All patients should be systemically healthy.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R20.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Dysesthesia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Patients who receive laser therapy on the area with neurosensory impairment in12 sessions with Gallium Aluminum Arsenide diode laser. Control group: Patients who do not receive any intervention and the laser probe will be placed on the area with neurosensory impairment turned off for 12 sessions</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Improvement in neurosensory function of inferior alveolar nerve. Timepoint: Baseline, after all 12 sessions and 3,6,9,12 months after last session. Method of measurement: Light touch sensation test with cotton swap.</prim_outcome>
      <prim_outcome>Improvement in neurosensory function of inferior alveolar nerve. Timepoint: Baseline, after all 12 sessions and 3,6,9,12 months after last session. Method of measurement: Two-Point discrimination test.</prim_outcome>
      <prim_outcome>Improvement in neurosensory function of inferior alveolar nerve. Timepoint: Baseline, after all 12 sessions and 3,6,9,12 months after last session. Method of measurement: Thermal test.</prim_outcome>
      <prim_outcome>Improvement in neurosensory function of inferior alveolar nerve. Timepoint: Baseline, after all 12 sessions and 3,6,9,12 months after last session. Method of measurement: Electric pulp test.</prim_outcome>
      <prim_outcome>Improvement in neurosensory function of inferior alveolar nerve. Timepoint: Baseline, after all 12 sessions and 3,6,9,12 months after last session. Method of measurement: Oral health impact profile questionnaire.</prim_outcome>
      <prim_outcome>Improvement in neurosensory function of inferior alveolar nerve. Timepoint: Baseline, after all 12 sessions and 3,6,9,12 months after last session. Method of measurement: Light touch sensation test with wooden cotton swap.</prim_outcome>
      <prim_outcome>Improvement in neurosensory function of inferior alveolar nerve. Timepoint: Baseline, after all 12 sessions and 3,6,9,12 months after last session. Method of measurement: Light touch sensation test with dental needle.</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>Artesh University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-05-27</approval_date>
        <contact_name>AJA University of Medical Sciences</contact_name>
        <contact_address>AJA University of Medical Sciences, Etemadzadeh St. , West Fatemi st. , Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
