<?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>IRCT2017021523620N7</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-05-10</date_registration>
      <primary_sponsor>Islamic Azad University, Dental Branch</primary_sponsor>
      <public_title>Efficacy of articaine buccal and lingual infiltration on pulp anesthesia</public_title>
      <acronym></acronym>
      <scientific_title>Comparison the effect of lidocaine inferior alveolar nerve block versus articaine buccal and lingual infiltration as primary injection on onset and duration of pulpal anesthesia in mandibular second molar with healthy pulp</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-03-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/20133</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research.</study_design>
      <phase>3</phase>
      <hc_freetext>Pulp.</hc_freetext>
      <i_freetext>Intervention 1: 1.8  mg articaine buccal and lingual infiltration on mandibular second molar in the intervention group. Intervention 2: 1.8  mg lidocaine inferior alveolar nerve block in the control group.</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>Dr Ehsan Esnaashari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 133, 9th Boostan, Pasdaran avenue, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1941733113</zip>
        <telephone>+98 21 2279 3163</telephone>
        <email>ehsan_dmd@yahoo.com</email>
        <affiliation>Islamic Azad University, Dental Branch</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Hengameh Bakhtiar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 4, 10th Neyestan, Pasdaran avenue, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1946853314</zip>
        <telephone>+98 21 2256 4571</telephone>
        <email>ehsan_dmd@yahoo.com</email>
        <affiliation>Islamic Azad University, Dental Branch</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: second mandibular molar teeth with healthy pulp. Exclusion criteria: systemic desease; sensitivity to anesthetic drugs; smocking and alcohol and drug addiction; acute infection and swelling</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>k04</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Deseases of pulp and periapical tissues</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>1.8  mg articaine buccal and lingual infiltration on mandibular second molar in the intervention group</i_keyword>
      <i_keyword>1.8  mg lidocaine inferior alveolar nerve block in the control group</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Onset pulp anesthesia. Timepoint: 5 minutes after injection, 8 minutes after injection, 11 minutes after injection, 15 minutes after injection, 20 minutes after injection, 25 minutes after injection, 30 minutes after injection, 45 minutes after injection, 60 minutes after injection, 75 minutes after injection, 90 minutes after injection. Method of measurement: In minutes.</prim_outcome>
      <prim_outcome>Duration of pulpal anesthesia. Timepoint: 5 minutes after injection, 8 minutes after injection, 11 minutes after injection, 15 minutes after injection, 20 minutes after injection, 25 minutes after injection, 30 minutes after injection, 45 minutes after injection, 60 minutes after injection, 75 minutes after injection, 90 minutes after injection. Method of measurement: In minutes.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Duration of anesthesia. Timepoint: 5 minutes after injection, 8 minutes after injection, 11 minutes after injection, 15 minutes after injection, 20 minutes after injection, 25 minutes after injection, 30 minutes after injection, 45 minutes after injection, 60 minutes after injection, 75 minutes after injection, 90 minutes after injection. Method of measurement: In minutes.</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, Dental Branch</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-12-20</approval_date>
        <contact_name>Islamic azad university,dental branch</contact_name>
        <contact_address>No 4, 10th Neyestan, Pasdaran avenue, Tehran, Iran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
