<?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>IRCT2015010120523N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-04-16</date_registration>
      <primary_sponsor>Dental Research Center, Research Institute of Dental Sciences of Shahid Beheshti University of Medic</primary_sponsor>
      <public_title>the effect of benzocaine-contained tooth paste in decreasing fixed orthodontic pain</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effect of benzocaine-contained tooth paste on relieving orthodontic pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-03-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>33</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/18187</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>pain percieved after fixed orthodontic appointment.</hc_freetext>
      <i_freetext>Intervention 1: benzocaine group: 5% benzocaine is added to a commercially available toothpaste, along with 0.075% Aspartam in order to mask benzocaine taste. each patient is given a toothpaste and asked to brush his/her teeth immediately after appointment, after breakfast and lunch and before sleep for 3 days. meanwhile, they are asked to mark their pain in a 0-100 scale, 2hours and 6hours after appointment, the same night before sleep, 10am and 6pm in second and third day and 10am at 7th day. Intervention 2: placebo group: a commercially available toothpaste is filled in identical tube as benzocaine tooth paste and is given to patients. patients are asked to use this toothpaste immediately after appointment, after breakfast and lunch and before sleep for 3 days. they are asked to mark their pain in a 0-100 scale 2 hours and 6 hours after appointment, at the same night before sleep, at 10am and 6pm on second and third day and at 10am on 7th day. Intervention 3: control group: the patients are given a questionnaire with a 0-100 scale to mark their pain 2hours and 6 hours after appointment, at the same night before sleep, at 10am and 6pm on second and third day, at 10am on 7th day.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sepideh Soheilifar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Orthodontic department, third floor, dental faculty, Shahid Beheshti University, Evin</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 2241 3897</telephone>
        <email>se.soheilifar@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ladan Eslamian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>orthodontic department, Dental Faculty, Shahid Beheshti Univeristy, Daneshjou Boulvard, Evin</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 2241 3897</telephone>
        <email>leslamian@gmail.com</email>
        <affiliation>Orthodontic department Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>inclusion criteria: patients in leveling and alignment stage who report pain in previous visit; presence of 6-8 crowding; patient informed consent &#13;
exclusion criteria:history of liver, kidney or allergy to local anesthesia; history of chronic pain and continuous administration of anti pain drugs; presence of dental or mucosal pain; presence of mucosal wound</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>20 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Y70-Y82</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Medical devices associated with adverse incidents in diagnostic and therapeutic use</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>benzocaine group: 5% benzocaine is added to a commercially available toothpaste, along with 0.075% Aspartam in order to mask benzocaine taste. each patient is given a toothpaste and asked to brush his/her teeth immediately after appointment, after breakfast and lunch and before sleep for 3 days. meanwhile, they are asked to mark their pain in a 0-100 scale, 2hours and 6hours after appointment, the same night before sleep, 10am and 6pm in second and third day and 10am at 7th day.</i_keyword>
      <i_keyword>placebo group: a commercially available toothpaste is filled in identical tube as benzocaine tooth paste and is given to patients. patients are asked to use this toothpaste immediately after appointment, after breakfast and lunch and before sleep for 3 days. they are asked to mark their pain in a 0-100 scale 2 hours and 6 hours after appointment, at the same night before sleep, at 10am and 6pm on second and third day and at 10am on 7th day.</i_keyword>
      <i_keyword>control group: the patients are given a questionnaire with a 0-100 scale to mark their pain 2hours and 6 hours after appointment, at the same night before sleep, at 10am and 6pm on second and third day, at 10am on 7th day.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: 2 hours and 6 hours after appointment, at the night of appointment, at 10am and 6pm on second and third day and on 10am on 7th day. Method of measurement: visual analogue scale (VAS) questionnaire.</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>Dental Research Center, Research Institute of Dental Sciences of Shahid Beheshti University of Medic</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-09-23</approval_date>
        <contact_name>Dental Research Center, Research Institute of Dental Sciences of Shahid Beheshti University of Medic</contact_name>
        <contact_address>Dental Faculty, Shahid Beheshti University of Medical Sciences, Daneshjou Boulvard, Evin Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
