<?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>IRCT20200509047369N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-05-21</date_registration>
      <primary_sponsor>Arak University of Medical Sciences</primary_sponsor>
      <public_title>The Comparison of the Effect of Needle Gauge on Pain and Anxiety of Children During Articaine Mandibular Buccal Infiltration Anesthesia</public_title>
      <acronym></acronym>
      <scientific_title>The Comparison of the Effect of Needle Gauge on Pain and Anxiety of Children During Articaine Mandibular Buccal Infiltration Anesthesia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-06-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/47998</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Teaching method: simple
Decision Making Unit: Possibility
Tools for providing services: To have a license in two groups based on demand and Thatcher Gage needle in the field of anesthesia injection using lottery and to select quadrant jaw in providing 60-person services, you can control half of the number once by using your normal resources. . Created by single and black envelopes
1: First consultation session: Gage needle 30                                             
    Second session: Gage needle 27
Group 2: First consultation session: Gage needle 27                                                                     
     Second session: Gage needle 30, Blinding description: The present study is of the three Socor type, as the patient, dentist, and statistical analyzer are unaware of how individuals are assigned to groups and the type of intervention performed at each session to treat individuals.</study_design>
      <phase>N/A</phase>
      <hc_freetext>The Comparison of the Effect of Needle Gauge on Pain and Anxiety of Children During Articaine Mandibular Buccal Infiltration Anesthesia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: injection of buccal maxillary infiltration anesthesia containing gauge needle 30. Anesthesia material is possible for you so that you can use articine as a c-kject needle by focal buccal infiltration with special features of ICT injection of genoss partners to 0.2 services. Intense collision. Intervention 2: Intervention group: injection of buccal maxillary infiltration anesthesia containing gauge needle 27. Anesthesia material is possible for you so that you can use articine as a c-kject needle by focal buccal infiltration with special features of ICT injection of genoss partners to 0.2 services. Intense collision.</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 further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hamid Sarlak</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>5th floor, Corner of Mirahmad Doctors Building, Shahid Beheshti St.</address>
        <city>arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3817985467</zip>
        <telephone>+98 86 3222 3794</telephone>
        <email>dr.hamidsarlak@yahoo.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hamid Sarlak</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>5th floor, Corner of Mirahmad Doctors Building, Shahid Beheshti St.</address>
        <city>arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3817985467</zip>
        <telephone>+98 86 3222 3794</telephone>
        <email>dr.hamidsarlak@yahoo.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All patients should be candidates for similar treatment for bilateral pulpotomy and SCC in the first molar teeth of the mandible
They are genetically, systemically and capable of healthy learning
They also have no history of dentistry and hospitalization.
In terms of cooperation criteria, Frankel is in a positive or positive position.</inclusion_criteria>
      <agemin>4 years</agemin>
      <agemax>8 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Existence of servere pain or obvious need for treatment on a side earlier of opposite side that excludes the study from a random state.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F41.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Anxiety disorder, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: injection of buccal maxillary infiltration anesthesia containing gauge needle 30. Anesthesia material is possible for you so that you can use articine as a c-kject needle by focal buccal infiltration with special features of ICT injection of genoss partners to 0.2 services. Intense collision</i_keyword>
      <i_keyword>Intervention group: injection of buccal maxillary infiltration anesthesia containing gauge needle 27. Anesthesia material is possible for you so that you can use articine as a c-kject needle by focal buccal infiltration with special features of ICT injection of genoss partners to 0.2 services. Intense collision</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pulse rate. Timepoint: The heart rate is measured three times in each treatment session (third and fourth sessions) and recorded by the dentist's assistant. 1. After the child sits on the unit (one minute before the injection) 2. 10 seconds after the start of the anesthesia injection Topical 3. At the time of pulp exposure. Method of measurement: The OXY300 digital electronic device (microlife AG.widnau.swit Switzerland) will be used to check the heart rate by placing the probe on the index finger of the child's left hand.</prim_outcome>
      <prim_outcome>Face pain rating. Timepoint: after injection of anesthesia. Method of measurement: Subjective measurement of pain is performed by FPR criteria after injection of anesthetic, which is recorded by the child using its scoring image and the score is compared with the next session in the presence of another confusion.</prim_outcome>
      <prim_outcome>Evaluation of pain by eye . movement and sound (SEM). Timepoint: during injection of anesthesia. Method of measurement: The objective criterion used to assess the amount of pain is the SEM criterion, which assesses the condition of the child's eyes and movements according to the scoring table. The score is determined by the dental assistant during the injection of anesthesia with one of the needle beads in the session. They will then be measured and recorded with Digger's gauge and compared.</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>Arak University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-05-06</approval_date>
        <contact_name>Ethics committee of arak University of Medical Sciences</contact_name>
        <contact_address>Academic complex of the Payambar Azam, Basij squre, Sardasht َArak Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
