<?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>IRCT2013022712634N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-12-25</date_registration>
      <primary_sponsor>Vice chancellor for research, Isfahan University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of Anesthesia Success Rate in Mandibular Inflammatory Tooth Between two Different Injection Techniques</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of Success Rate of Inferior Alveolar Nerve Block versus IntraOsseous Injection For Pulpal Anesthesia in The Posterior Mandibular Teeth with Irreversible Pulpitis in patients attending to Afzal dental clinic, Isfahan, Iran 1391-92</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-10-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/12653</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>tooth with irreversible pulpitis.</hc_freetext>
      <i_freetext>Intervention 1: For the first group, primary pulpal anesthesia will provide with Intra Osseous injection of Mepivacaine 3%. Intervention 2: For the second group, primary pulpal anesthesia will provide with Inferior Alveolar Nerve Block injection of Mepivacaine 3%.</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>Shafeie Maryam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 33, Shahid Hamidii alley, Bozorgmehr ave, Ahmadabad Square</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 31 1226 3421</telephone>
        <email>marymahsash@gmail.com</email>
        <affiliation>Isfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shafeie Maryam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 33, Shahid Hamidi alley, Bozorgmehr ave, Ahmadabad square</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 31 1226 3421</telephone>
        <email>marymahsash@gmail.com</email>
        <affiliation>Isfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: &#13;
1) Patients with at least one posterior mandibular tooth with irreversible pulpitis for pulp therapy that each pulp therapy would be appliable thoroughly in one visit;&#13;
2)  No history of taking any medication that would alter the inflammatory response of the pulp or provide analgesia for the previous 14 days;&#13;
3) No history of major systemic or cardiovascular disease;&#13;
4) Patients aged 18 to 65 years old;&#13;
5) Absence of acute inflammation and advanced periodontal disease at the injection area;&#13;
6) Provision written informed consent;&#13;
Exclusion criteria: &#13;
1) Any history of alergy to anesthetic solutions;&#13;
2) lack of cooperation or interest of patient to continue the study.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>k04.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pulpitis: NOS acute chronic (hyperplastic)(ulcerative) irreversible reversible</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>For the first group, primary pulpal anesthesia will provide with Intra Osseous injection of Mepivacaine 3%</i_keyword>
      <i_keyword>For the second group, primary pulpal anesthesia will provide with Inferior Alveolar Nerve Block injection of Mepivacaine 3%</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Success of the Anesthesia. Timepoint: After the Injection and during root canal therapy (RCT). Method of measurement: Vitality pulp test (pulp tester and endo ice) before RCT and questioning from patients during RCT.</prim_outcome>
      <prim_outcome>Pain. Timepoint: During injection of Anesthetic solution. Method of measurement: Heft-parker visual Analogue Scale.</prim_outcome>
      <prim_outcome>Blood Pressure. Timepoint: Before and After Anesthetic injection. Method of measurement: Digital indicator -mmhg.</prim_outcome>
      <prim_outcome>Onset of Anesthesia. Timepoint: After the injection with 1-minute intervals for a period of 15 minutes. Method of measurement: Vitality pulp test (pulp tester and endo ice).</prim_outcome>
      <prim_outcome>Duration of Anesthesia. Timepoint: From the beginning to the end of RCT. Method of measurement: Asking from the patients.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Hematoma. Timepoint: One hour after the injection. Method of measurement: Observation.</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, Isfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-06-12</approval_date>
        <contact_name>Bioethics Committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Building number 4, Isfahan University of Medical Sciences, Hezar Jarib Ave Isfahan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
