<?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>IRCT20220425054651N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-04-29</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of local anesthesia for dental treatment of children on physiologic parameters of patients</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effect of local anesthesia for dental treatment of children under general anesthesia on physiologic parameters of the patient and on recovery of the patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-05-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>142</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63183</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Candidate children for general anesthesia undergoing dental treatment referred to Tehran Dental School will be randomly divided into two intervention groups (local anesthesia during dental treatment) and the control group (without local anesthesia during dental treatment) by the size 43 permutation block method, Blinding description: The present study is two-way blind, and the outcome assessor, data analyst, and study participant are not aware of the type of intervention. The outcome researcher and evaluator are unaware of the randomization of patients to the two groups receiving local anesthesia and not receiving local anesthesia and do not intervene. Vials containing local anesthesia and vials without local anesthesia are prepared in advance by an operating room nurse who is not involved in collecting, analyzing, and evaluating the outcome.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Dental root caries.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Children who need dental treatment under general anesthesia and receive local anesthetic lidocaine 2% epinephrine 1: 100,000 at 3 minutes before the start of treatment. They are then treated with a pulpotomy. Physiological parameters and recovery time, and patients' pain are measured and recorded during and after treatment. Intervention 2: Control group: Children who need dental treatment under general anesthesia. They are then treated with a pulpotomy. Physiological parameters and recovery time, and patients' pain are measured and recorded during and after treatment.</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 There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ali Baghalian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Dentistry, Tehran University of Medical Sciences, North Karegar  St,Tehran-Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۴۳۹۹۵۵۹۹۱</zip>
        <telephone>+98 21 4279 4500</telephone>
        <email>abaghalian@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Baghalian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Dentistry, Tehran University of Medical Sciences, North Karegar  St,Tehran-Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۴۳۹۹۵۵۹۹۱</zip>
        <telephone>+98 21 4279 4500</telephone>
        <email>abaghalian@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Children who are medically in the ASA I or ASA II category.
Children need anesthesia treatment according to the initial examination for dental treatment.
Children need pulp therapy and dental veneers in the maxilla.</inclusion_criteria>
      <agemin>3 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The child or his / her parents are not satisfied with participating in the study.
Children with certain medical conditions, such as any systemic disease such as heart disease, kidney disease, allergy to local anesthetics, etc.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K02.7</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Dental root caries</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Children who need dental treatment under general anesthesia and receive local anesthetic lidocaine 2% epinephrine 1: 100,000 at 3 minutes before the start of treatment. They are then treated with a pulpotomy. Physiological parameters and recovery time, and patients' pain are measured and recorded during and after treatment.</i_keyword>
      <i_keyword>Control group: Children who need dental treatment under general anesthesia. They are then treated with a pulpotomy. Physiological parameters and recovery time, and patients' pain are measured and recorded during and after treatment.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Heart rate. Timepoint: Immediately after the start of pulpotomy treatment, at the moment of chamber pulp entry, at the end of coronary pulp removal, and the completion of pulpotomy treatment. Method of measurement: Heart rate recorder.</prim_outcome>
      <prim_outcome>Arterial blood pressure. Timepoint: Immediately after the start of pulpotomy treatment, at the moment of chamber pulp entry, at the end of coronary pulp removal, and the completion of pulpotomy treatment. Method of measurement: Mercury barometer.</prim_outcome>
      <prim_outcome>Arterial oxygen saturation level. Timepoint: Immediately after the start of pulpotomy treatment, at the moment of chamber pulp entry, at the end of coronary pulp removal, and at the completion of pulpotomy treatment. Method of measurement: Arterial oxygen measuring device.</prim_outcome>
      <prim_outcome>End-tidal CO۲. Timepoint: Immediately after the start of pulpotomy treatment, at the moment of chamber pulp entry, at the end of coronary pulp removal, and at the completion of pulpotomy treatment. Method of measurement: End-tidal CO۲ recorder.</prim_outcome>
      <prim_outcome>Recovery time. Timepoint: After surgery. Method of measurement: Time elapsed (minutes).</prim_outcome>
      <prim_outcome>The amount of pain. Timepoint: After recovery. Method of measurement: Alderete Index.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-10-30</approval_date>
        <contact_name>Ethics Committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Central office of Tehran University of Medical Sciences, Ghods St, Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
