<?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>IRCT20210103049926N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-08-28</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>The impact of media on children's oral health</public_title>
      <acronym></acronym>
      <scientific_title>Multimedia and virtual reality effect on distraction and oral health education in 4-6 year old children</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53475</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: 60 children with inclusion criteria will enter the study. These people will be randomly divided into 4 groups. The method of randomization is simple and its unit is individual. The randomization tool is a table of random numbers. In order to hide the random allocation, sealed envelopes will be used.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Oral health.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group1: In the first session, the tools used by the usual method of behavioral control technique will be introduced to children. Also, to determine the initial oral health status of the child, plaque detection pills and plaque index will be calculated. In this group, Brushing with horizontal method will be taught to children and their parents by using a VR headset and playing a cartoon about How to brush. In the second session, class one or two restoration of the first or second mandibular primary molars with injecting inferior alveolar nerve block will be done using VR method and by playing a part of Tom and Jerry cartoon, and the anxiety and behavior of children Will be assessed. At the end of session the subjects’ anxiety will be measured by Faces version of the Modified Child Dental Anxiety Scale and their behavior will be recorded based on the Frankel Classification Scale. The improvement of oral health will be re-examined in two follow-up session by the plaque index. Intervention 2: Intervention group2: In the first session, the tools used by the usual method of behavioral control technique will be introduced to children. Also, to determine the initial oral health status of the child, plaque detection pills and plaque index will be calculated. In this group, Brushing with horizontal method will be taught to children and their parents by using a television and playing a cartoon about How to brush. In the second session, class one or two restoration of the first or second mandibular primary molars with injecting inferior alveolar nerve block will be done using television and by playing a part of Tom and Jerry cartoon, and the anxiety and behavior of children Will be assessed. At the end of session the subjects’ anxiety will be measured by Faces version of the Modified Child Dental Anxiety Scale and their behavior will be recorded based on the Frankel Classification Scale. The improvement of oral health will be re-examined in two follow-up session by the plaque index. Intervention 3: Intervention group3: In the first session, the tools used by the usual method of behavioral control technique will be introduced to children. Also, to determine the initial oral health status of the child, plaque detection pills and plaque index will be calculated. In this group, Brushing with horizontal method will be taught to children and their parents by using a tablet and playing a cartoon about How to brush. In the second session, class one or two restoration of the first or second mandibular primary molars with injecting inferior alveolar nerve block will be done using tablet and by playing a part of Tom and Jerry cartoon, and the anxiety and behavior of children Will be assessed. At the end of session the subjects’ anxiety will be measured by Faces version of the Modified Child Dental Anxiety Scale and their behavior will be recorded based on the Frankel Classification Scale. The improvement of oral health will be re-examined in two follow-up session by the plaque index. Intervention 4: Control group:  In the first session, the tools used by the usual method of behavioral control technique will be introduced to children. Also, to determine the initial oral health status of the child, plaque detection pills and plaque index will be calculated. In this group, Brushing with horizontal method will be taught to children and their parents by using usual method tell-show-do (TSD) and playing a cartoon about How to brush. In the second session, class one or two restoration of the first or second mandibular primary molars with injecting inferior alveolar nerve block will be done using TSD , and the anxiety and behavior of children Will be assessed. At the end of session the subjects’ anxiety will be measured by Faces version of the Modified Child Dental Anxiety Scale  and their behavior will be recorded based on the Frankel Classification Scale. The improvement of oral health will be re-examined in two follow-up session by the plaque index.</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>Ozra Golsanamlou</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golgasht st.dentistry faculty, pediatric dentistry department</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614711</zip>
        <telephone>+98 41 3384 6713</telephone>
        <email>dr.golsanamlou92@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Naser Aslaminabadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golgasht Ave</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614711</zip>
        <telephone>+98 41 3335 5965</telephone>
        <email>aslaminabadi@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Children should be 4 to 6 years old.
Children should not have any dental treatment history.
Children should have at least 1 tooth that need restorative treatment.</inclusion_criteria>
      <agemin>4 years</agemin>
      <agemax>6 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Children have major anxiety disorders.
Symptoms of respiratory disease or Covid 19 disease are seen in the child.
Children need emergency dental treatment.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group1: In the first session, the tools used by the usual method of behavioral control technique will be introduced to children. Also, to determine the initial oral health status of the child, plaque detection pills and plaque index will be calculated. In this group, Brushing with horizontal method will be taught to children and their parents by using a VR headset and playing a cartoon about How to brush. In the second session, class one or two restoration of the first or second mandibular primary molars with injecting inferior alveolar nerve block will be done using VR method and by playing a part of Tom and Jerry cartoon, and the anxiety and behavior of children Will be assessed. At the end of session the subjects’ anxiety will be measured by Faces version of the Modified Child Dental Anxiety Scale and their behavior will be recorded based on the Frankel Classification Scale. The improvement of oral health will be re-examined in two follow-up session by the plaque index.</i_keyword>
      <i_keyword>Intervention group2: In the first session, the tools used by the usual method of behavioral control technique will be introduced to children. Also, to determine the initial oral health status of the child, plaque detection pills and plaque index will be calculated. In this group, Brushing with horizontal method will be taught to children and their parents by using a television and playing a cartoon about How to brush. In the second session, class one or two restoration of the first or second mandibular primary molars with injecting inferior alveolar nerve block will be done using television and by playing a part of Tom and Jerry cartoon, and the anxiety and behavior of children Will be assessed. At the end of session the subjects’ anxiety will be measured by Faces version of the Modified Child Dental Anxiety Scale and their behavior will be recorded based on the Frankel Classification Scale. The improvement of oral health will be re-examined in two follow-up session by the plaque index.</i_keyword>
      <i_keyword>Intervention group3: In the first session, the tools used by the usual method of behavioral control technique will be introduced to children. Also, to determine the initial oral health status of the child, plaque detection pills and plaque index will be calculated. In this group, Brushing with horizontal method will be taught to children and their parents by using a tablet and playing a cartoon about How to brush. In the second session, class one or two restoration of the first or second mandibular primary molars with injecting inferior alveolar nerve block will be done using tablet and by playing a part of Tom and Jerry cartoon, and the anxiety and behavior of children Will be assessed. At the end of session the subjects’ anxiety will be measured by Faces version of the Modified Child Dental Anxiety Scale and their behavior will be recorded based on the Frankel Classification Scale. The improvement of oral health will be re-examined in two follow-up session by the plaque index.</i_keyword>
      <i_keyword>Control group:  In the first session, the tools used by the usual method of behavioral control technique will be introduced to children. Also, to determine the initial oral health status of the child, plaque detection pills and plaque index will be calculated. In this group, Brushing with horizontal method will be taught to children and their parents by using usual method tell-show-do (TSD) and playing a cartoon about How to brush. In the second session, class one or two restoration of the first or second mandibular primary molars with injecting inferior alveolar nerve block will be done using TSD , and the anxiety and behavior of children Will be assessed. At the end of session the subjects’ anxiety will be measured by Faces version of the Modified Child Dental Anxiety Scale  and their behavior will be recorded based on the Frankel Classification Scale. The improvement of oral health will be re-examined in two follow-up session by the plaque index.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Oral health promotion that evaluated by plaque index. Timepoint: 2 times evaluating oral health promotion at one month intervals. Method of measurement: Plaque index.</prim_outcome>
      <prim_outcome>Anxiety. Timepoint: Evaluating  anxiety during tooth restoration. Method of measurement: Faces version of the Modified Child Dental Anxiety Scale  questionnaire.</prim_outcome>
      <prim_outcome>Evaluating Behavior. Timepoint: Evaluating  behavior during tooth restoration. Method of measurement: Frankel Behavior Scale.</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-06-29</approval_date>
        <contact_name>Ethnic commitee of Tabriz university of medical sciences</contact_name>
        <contact_address>Golgasht Ave., Tabriz city Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
