<?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>IRCT201605116105N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-06-02</date_registration>
      <primary_sponsor>Vice chancellor for Research, Zahedan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of tactile or visual determination of injection site on subjective and objective pain reactions and success rate of inferior alveolar nerve block in children</public_title>
      <acronym>-</acronym>
      <scientific_title>The effect of tactile or visual determination of injection site on subjective and objective pain reactions and success rate of inferior alveolar nerve block in children</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-09-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/6553</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Other design features: -.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Local anesthesia,.</hc_freetext>
      <i_freetext>Intervention 1: Intervention 1:&#13;
Applying topical anesthesia gel (TOPEX, Sultan Healthcare IND. CO, USA) by cotton applicator  at the injection site on dried mucosa for 60 seconds, administration mandibular block anesthesia by using visual method to find the needle insertion site by delivering 1 ml of   lidocaine %2 with epinephrine1:80000 (Persocaine-E, Darou Pakhsh IND. CO, Iran) with temperature of  21 °C by using Anthogyr syring (France) with needle guage 27 and length of 35mm (C- KJECT, CK DENTAL IND. CO, Korea) within 1.5 minutes. Intervention 2: Intervention 2:&#13;
Applying topical anesthesia gel (TOPEX, Sultan Healthcare IND. CO, USA) by cotton applicator at the injection site on dried mucosa for 60 seconds, administration mandibular block anesthesia by using tactile method to find the needle insertion site by delivering 1 ml of lidocaine %2 with epinephrine 1:80000 (Persocaine-E, Darou Pakhsh IND. CO, Iran) with temperature of  21 °C  by using Anthogyr syringe (France) with needle guage of 27 and length of 35mm (C- KJECT, CK DENTAL IND. CO, Korea) within 1.5  minutes.</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>Nahid Ramazani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Zahedan dentistry School, Azadegan East Street, Zahedan</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9817699693</zip>
        <telephone>+98 54 3342 3218</telephone>
        <email>ramazani_nahid@yahoo.com</email>
        <affiliation>Zahedan dentistry School</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nahid Ramazani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Zahedan dentistry School, Azadegan East Street, Zahedan</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9817699693</zip>
        <telephone>+98 54 3342 3218</telephone>
        <email>ramazani_nahid@yahoo.com</email>
        <affiliation>Zahedan dentistry School</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: children between 7-9 years old, require treatment in the mandibular second primary molar, a full physical and mental health, located in the classification of Frankel positive or definitely positive during behavioral assessment before treatment, identified the pterygomandibular triangle landmark in intraoral examination.&#13;
Exclusion criteria: previous dental history, allergies to medication or anesthetic, emergency mode or pulp origin tooth pain, no need to premedication before dental treatment.</inclusion_criteria>
      <agemin>7 years</agemin>
      <agemax>9 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Y48.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Local anaesthetics</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention 1:&#13;
Applying topical anesthesia gel (TOPEX, Sultan Healthcare IND. CO, USA) by cotton applicator  at the injection site on dried mucosa for 60 seconds, administration mandibular block anesthesia by using visual method to find the needle insertion site by delivering 1 ml of   lidocaine %2 with epinephrine1:80000 (Persocaine-E, Darou Pakhsh IND. CO, Iran) with temperature of  21 °C by using Anthogyr syring (France) with needle guage 27 and length of 35mm (C- KJECT, CK DENTAL IND. CO, Korea) within 1.5 minutes.</i_keyword>
      <i_keyword>Intervention 2:&#13;
Applying topical anesthesia gel (TOPEX, Sultan Healthcare IND. CO, USA) by cotton applicator at the injection site on dried mucosa for 60 seconds, administration mandibular block anesthesia by using tactile method to find the needle insertion site by delivering 1 ml of lidocaine %2 with epinephrine 1:80000 (Persocaine-E, Darou Pakhsh IND. CO, Iran) with temperature of  21 °C  by using Anthogyr syringe (France) with needle guage of 27 and length of 35mm (C- KJECT, CK DENTAL IND. CO, Korea) within 1.5  minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Objective and subjective pain reaction. Timepoint: During injection and after intervention 1 and 2. Method of measurement: Using SEM scale and using FIS.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Success of anesthesia. Timepoint: During access cavity preparation, after intervention 1 and 2  and 5 minutes waiting period. Method of measurement: Using SEM scale.</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>Vice chancellor for Research, Zahedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-04-19</approval_date>
        <contact_name>Ethics committee of Zahedan University of Medical Sciences</contact_name>
        <contact_address>Pardis Department of Zahedan University of Medical Sciences, Khalije Fars Boulvard, Dr.Hesabi Square, Zahedan Zahedan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
