<?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>IRCT20190520043644N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-12-15</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Effect of laser diode on the repair of inferior alveolar sensory nerve damage</public_title>
      <acronym></acronym>
      <scientific_title>The comparison of 940nm and 810nm diode laser type effects on the repair of inferior alveolar sensory nerve damage</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-05-27</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>39</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/39817</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method consists of a quadrilateral random block
In this method the size of the blocks is selected at random
Each block contains an equal number of each group
For ethical consideration and standard treatment, all patients were treated with vitamin B1 300 mg once daily and gabapentin 100 mg once daily
Then patients are divided into three groups: 810nm diode laser, 940nm diode laser irradiation and no laser irradiation (control group), Blinding description: The patient does not know what diode (940nm laser diode or 810nm laser diode or normal diode) will light up his nerve.
Clinical supervision of the device and only diode light to the patient's nerve and is not known about the type of diode used.
The outcome evaluator will only review the patient and record the result in a file that does not use the type of diode he or she uses.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Inferior alveolar sensory nerve damage.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Under the 810 nm diode laser beam                                810nm Laser: Diode laser with GaAlAc medium (Gallium Aluminum Arsenide) with 810nm wavelength manufactured by Thor UK         Different Sessions: The first three days of the seventh to the twelfth hour Treatment Specifications: At each session, 400mW laser irradiation in twenty seconds for the three nerve entry sites to the mandibular foramen, lip, and one area between these two regions is equal to 1cm2 of Spot Area. Intervention 2: Intervention group: Under the 940nm diode laser beam                      940nm Laser: 940nm Medium GaInP (Gallium Endium Phosphate) Diode Laser Made by US Biolase                                                                   Different Sessions: The first three days of the seventh to the twelfth hour Treatment Specifications: At each session, 400mW laser irradiation in twenty seconds for the three nerve entry sites to the mandibular foramen, lip, and one area between these two regions is equal to 1cm2 of Spot Area. Intervention 3: Control group: No intervention                                                                          For ethical consideration and standard treatment, all patients were treated with vitamin B1 300 mg once daily and gabapentin 100 mg once daily.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hooman Ebrahimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 9, Neyestan 9 Ave., Pasdaran Plvd.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1946853314</zip>
        <telephone>+98 21 2256 4571</telephone>
        <email>hooman.ebrahimi@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hooman Ebrahimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 9, Neyestan 9 Ave., Pasdaran Plvd.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1946853314</zip>
        <telephone>+98 21 2256 4571</telephone>
        <email>hooman.ebrahimi@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>With sensory and neuropathic disturbances
Sensory nerve damage due to dental treatments
Less than 6 months of injury
Treated with laser
Systemic diseases</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Sensory nerve damage is due to trauma
Already exposed to laser radiation
History of drug addiction
Smoking</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T88.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other complications of anesthesia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Diagnosis</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Under the 810 nm diode laser beam                                810nm Laser: Diode laser with GaAlAc medium (Gallium Aluminum Arsenide) with 810nm wavelength manufactured by Thor UK         Different Sessions: The first three days of the seventh to the twelfth hour Treatment Specifications: At each session, 400mW laser irradiation in twenty seconds for the three nerve entry sites to the mandibular foramen, lip, and one area between these two regions is equal to 1cm2 of Spot Area</i_keyword>
      <i_keyword>Intervention group: Under the 940nm diode laser beam                      940nm Laser: 940nm Medium GaInP (Gallium Endium Phosphate) Diode Laser Made by US Biolase                                                                   Different Sessions: The first three days of the seventh to the twelfth hour Treatment Specifications: At each session, 400mW laser irradiation in twenty seconds for the three nerve entry sites to the mandibular foramen, lip, and one area between these two regions is equal to 1cm2 of Spot Area</i_keyword>
      <i_keyword>Control group: No intervention                                                                          For ethical consideration and standard treatment, all patients were treated with vitamin B1 300 mg once daily and gabapentin 100 mg once daily</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The number of people with a fatigue rating above 3. Timepoint: After the sessions 1, 3, 7 and 12 treatment. Method of measurement: Numerical Scale.</prim_outcome>
      <prim_outcome>The number of people who tested the clinical neurosensory test. Timepoint: After the sessions 1, 3, 7 and 12 treatment. Method of measurement: Brush Stroke test with the criterion for detecting one of two horizontal and vertical movements, Two Point Discrimination test with a minimum recording distance of less than 10 mm, Thermal Discrimination test with a heat and cold detection criterion, and a Pin Prick Nociception test with a metric for registering more hits. From 30%.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-05-04</approval_date>
        <contact_name>Ethics committee of Department of Dentistry, Islamic Azad University, Tehran, Iran</contact_name>
        <contact_address>No. 9, Neyestan 9 Ave., Pasdaran Plvd. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
