<?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>IRCT20180104038218N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-09-29</date_registration>
      <primary_sponsor>Qazvin University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effect of oral sweet taste on pain level of upper jaw anesthesia in children 6-9 years old</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effect of oral sweet taste on pain level of maxillary infiltration anesthesia in children 6-9 years old</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>32</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58982</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization using an sealed envelope with an equal number of intervention (sweet taste) and control (water) samples is placed in a package and provided to the ward nurse, each time the nurse (Who has no role in the continuation of the study) pulls one of the envelopes and it is determined that the patient receives intervention or control, Blinding description: Outcome assessment is performed by a person other than the researcher and clinical caregiver and because he / she is present at the patient's bedside after the intervention, he / she is blind to the received intervention.
The grouping results of each sample are delivered to the statistical analyzer in the form of numbers.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Injection in pediatric dentistry.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the first session, children receive brushing and fluoride therapy to shape their behavior, and in the next session, after using the tell-show-do technique, they undergo infiltration in the area of ​​the first maxillary molars.  The intervention group receives 25% sweet solution (25 g of sucrose (Merck, Germany) -75 cc of distilled water) before performing the work. The child is asked to hold the solution in the mouth for two minutes. The injection technique in both groups was the same, first by applying a topical benzocaine gel (20%) to the mucosa for one minute and then a cartridge of 1.8 ml of 2% lidocaine + epinephrine 1: 80000 (Daroupakhsh, Iran) and a needle. 25 mm with gauge 27 (Sirio, Italy). After pulling the mucosa, the needle is inserted at a 45 degree angle of 1-2 mm into the mucosa and a few drops are injected. After aspiration, more progress is made and the injection is completed. All injections are given by one person. Intervention 2: Control group:  In the first session, children receive brushing and fluoride therapy to shape their behavior, and in the next session, after using the tell-show-do technique, they undergo infiltration in the area of ​​the first maxillary molars.The intervention group receives regular drinking water before performing the work. The child is asked to hold water in the mouth for two minutes. The injection technique in both groups was the same, first by applying a topical benzocaine gel (20%) to the mucosa for one minute and then a cartridge of 1.8 ml of 2% lidocaine + epinephrine 1: 80000 (Daroupakhsh, Iran) and a needle. 25 mm with gauge 27 (Sirio, Italy). After pulling the mucosa, the needle is inserted at a 45 degree angle of 1-2 mm into the mucosa and a few drops are injected. After aspiration, more progress is made and the injection is completed. All injections are given by one person.</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 No additional information exists</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Razieh Jabbarian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bahonar Boulvard</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3471976160</zip>
        <telephone>+98 28 3335 3062</telephone>
        <email>r.jabbarian@qums.ac.ir</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Razieh Jabbarian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bahonar Boulvard</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3471976160</zip>
        <telephone>+98 28 3335 3062</telephone>
        <email>r.jabbarian@qums.ac.ir</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Children 6-9 years old requiring pulp treatment of maxillary first molar
Physical health in terms of systemic and developmental
Positive behavior according to Frankle classification (cooperative and without resistance to treatment)
Do not eat or drink anything for at least one hour before the injection</inclusion_criteria>
      <agemin>6 years</agemin>
      <agemax>9 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Allergies or contraindications to the use of sweets
The presence of spontaneous / nocturnal pain or abscess in the desired tooth
Pain, inflammation and any other problems in the injection site</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G89.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute pain, not elsewhere classified</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: In the first session, children receive brushing and fluoride therapy to shape their behavior, and in the next session, after using the tell-show-do technique, they undergo infiltration in the area of ​​the first maxillary molars.  The intervention group receives 25% sweet solution (25 g of sucrose (Merck, Germany) -75 cc of distilled water) before performing the work. The child is asked to hold the solution in the mouth for two minutes. The injection technique in both groups was the same, first by applying a topical benzocaine gel (20%) to the mucosa for one minute and then a cartridge of 1.8 ml of 2% lidocaine + epinephrine 1: 80000 (Daroupakhsh, Iran) and a needle. 25 mm with gauge 27 (Sirio, Italy). After pulling the mucosa, the needle is inserted at a 45 degree angle of 1-2 mm into the mucosa and a few drops are injected. After aspiration, more progress is made and the injection is completed. All injections are given by one person.</i_keyword>
      <i_keyword>Control group:  In the first session, children receive brushing and fluoride therapy to shape their behavior, and in the next session, after using the tell-show-do technique, they undergo infiltration in the area of ​​the first maxillary molars.The intervention group receives regular drinking water before performing the work. The child is asked to hold water in the mouth for two minutes. The injection technique in both groups was the same, first by applying a topical benzocaine gel (20%) to the mucosa for one minute and then a cartridge of 1.8 ml of 2% lidocaine + epinephrine 1: 80000 (Daroupakhsh, Iran) and a needle. 25 mm with gauge 27 (Sirio, Italy). After pulling the mucosa, the needle is inserted at a 45 degree angle of 1-2 mm into the mucosa and a few drops are injected. After aspiration, more progress is made and the injection is completed. All injections are given by one person.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Objective level of pain. Timepoint: After completion of anesthesia. Method of measurement: Face,leg,activity,crying,consolability (FLACC).</prim_outcome>
      <prim_outcome>Subjective level of pain. Timepoint: After completion of anesthesia. Method of measurement: Wong Baker.</prim_outcome>
      <prim_outcome>Heart rate. Timepoint: Before, during and after injection. Method of measurement: Pulse oximeter.</prim_outcome>
      <prim_outcome>Blood level of oxygen saturation. Timepoint: Before, during and after injection. Method of measurement: Pulse oximeter.</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>Qazvin University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-08-21</approval_date>
        <contact_name>Ethics Committee of Qazvin University of Medical Sciences</contact_name>
        <contact_address>Bahonar Boulvard Qazvin Qazvin Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
