<?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>IRCT20150924024167N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-03-07</date_registration>
      <primary_sponsor>Islamic Azad university of medical science, school of dentistry</primary_sponsor>
      <public_title>Comparing of effectiveness of two anesthetic techniques on inferior alveolar nerve block</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effectiveness between conventional and modified inferior alveolar nerve block techniques</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>37</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/45683</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The study is performed using the split-mouth method (each side of the mandible as a group) and with the coin method, the starting position (left or right) will be selected for every patient; then each patient, without knowing which numbers correspond to any of the methods, chooses between 1 and 2 numbers in different envelopes (2 as modified and 1 as conventional)  to get started, Blinding description: Patients are unaware of the type of anesthesia and side of mandible, which  will be performed first.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Indication of posterior teeth anesthesia in the form of bilateral.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: as modified technique, a 1.8 cc Lidocaine 2% anesthetic solution with 1.80000 epinephrine is used. The syringe body is placed on the occlusal of the first molar on the opposite side, and needle enters perpendicular to the medial mandibular ramus just lateral to the pterygomandibular fold and needle enters on 10 mm or so above the occlusal plane and parallel to it.                                                                  The techniques will be considered successful if the lip and tongue is anesthetized after 5 minutes and if did not happen for another 5 minutes the injection will be repeated one time more. Intervention 2: Control group: as conventional method, a 1.8 cc Lidocaine 2% anesthetic solution with 1.80000 epinephrine is used. The syringe body is placed on the opposite premolars and needle enters ¾ anterior posterior distance from Coronoid process to pterygomandibular raphe and with the line that is perpendicular to it from the tuberosity, and needle enters on 10 mm or so above the occlusal plane and parallel to it.                                           The techniques will be considered successful if the lip and tongue is anesthetized after 5 minutes and if did not happen for another 5 minutes the injection will be repeated one time more.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is to consider publishing a paper</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Esshagh Lasemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.9, Neyestan 9th, Pasdaran Ave.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1946853314</zip>
        <telephone>+98 21 2256 4571</telephone>
        <email>elasemi@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Esshagh Lasemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.9, Neyestan 9th, Pasdaran Ave.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1946853314</zip>
        <telephone>+98 21 2256 4571</telephone>
        <email>elasemi@yahoo.com</email>
        <affiliation>Islamic Azad university of medical science, school of dentistry</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients who need the bilateral IANB for posterior mandibular tooth extractions.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Systemic diseases
Infection in the area
History of sensitivity reaction to the anesthetic solutions
History of surgery or fracture of the ramus
َAny medicament altering the pain perception
Psychiatry disorders</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>DA07.8    </hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>DA07.8: An impacted tooth is a tooth that is all the way or partially below the gum line and is not able to erupt properly. Wisdom teeth (third molars) as the most commonly impacted teeth;  DA0A.1: extraction or local periodontal disease.</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 group: as modified technique, a 1.8 cc Lidocaine 2% anesthetic solution with 1.80000 epinephrine is used. The syringe body is placed on the occlusal of the first molar on the opposite side, and needle enters perpendicular to the medial mandibular ramus just lateral to the pterygomandibular fold and needle enters on 10 mm or so above the occlusal plane and parallel to it.                                                                  The techniques will be considered successful if the lip and tongue is anesthetized after 5 minutes and if did not happen for another 5 minutes the injection will be repeated one time more.</i_keyword>
      <i_keyword>Control group: as conventional method, a 1.8 cc Lidocaine 2% anesthetic solution with 1.80000 epinephrine is used. The syringe body is placed on the opposite premolars and needle enters ¾ anterior posterior distance from Coronoid process to pterygomandibular raphe and with the line that is perpendicular to it from the tuberosity, and needle enters on 10 mm or so above the occlusal plane and parallel to it.                                           The techniques will be considered successful if the lip and tongue is anesthetized after 5 minutes and if did not happen for another 5 minutes the injection will be repeated one time more.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Comparison of success rates between conventional and modified technique in the inferior alveolar nerve block. Timepoint: During the intervention. Method of measurement: Inquiring from patient - Observing, Testing and Measuring by the Researcher.</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 of medical science, school of dentistry</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-02-27</approval_date>
        <contact_name>Ethics committee of Islamic Azad University of Medical Sciences, Dental school</contact_name>
        <contact_address>No.9, Neyestan 9th, Pasdaran Ave. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
