<?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>IRCT20250324065150N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-04-10</date_registration>
      <primary_sponsor>Boushehr University of Medical Sciences</primary_sponsor>
      <public_title>Comparing the effects of video and flashcard-based tooth brushing training in children with autism spectrum disorder.</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effectiveness of two methods of teaching tooth brushing, using flashcards and video in children with autism spectrum disorder.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-04-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>74</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/82586</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: At each center, papers were prepared for the number of people eligible to participate in the study. Half of the papers were coded for the first intervention and the other half for the second intervention (video or flashcard training). The papers were folded so that it was not clear which one was related to which intervention. At each center, the papers were randomly distributed among the sample members. Gender and disease profile matching was performed at the group level.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Teaching individuals with autism spectrum disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: A group that learns how to brush their teeth with an educational video. Intervention 2: Control group: A group that learns how to brush their teeth with flash cards.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
First, the data is made unidentifiable through coding, and then all data will be publishable.

When:
Access period begins three months after results are published.

To whom:
Researchers working in academic centers and educational and rehabilitation centers related to children with autism can apply for access to the data.

Conditions:
No other conditions are considered, any statistical analysis is permitted, access and use of de-identified data from this study is permitted to help people with autism.

Where to obtain:
De-identified data will be sent via email to the requesting researcher or journal.
Author's name: Mahdiyeh Khiabani
email: mahdiye.khiabany@gmail.com

How to obtain:
This article will be published as an original research article in a journal with a matching scope or topic, based on the standard checklist (CONSORT).
After the publication of the article, other researchers or journals can request to receive the data by sending a request to the person responsible for the study, Mahdiye Khiabani, at the email address mahdiye.khiabany@gmail.com. After sending the request, the data will be made available to them within two weeks at the most.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahdieh Kheyabani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 9, Taj Building, 1 Nasaji Alley, Devas Neighborhood</address>
        <city>Bushehr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7516875530</zip>
        <telephone>+98 77 9109 0160</telephone>
        <email>mahdiye.khiabany@gmail.com</email>
        <affiliation>Boushehr University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahdieh Kheyabani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 9, Taj Building, 1 Nasaji Alley, Devas Neighborhood</address>
        <city>Bushehr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7516875530</zip>
        <telephone>+98 77 9109 0160</telephone>
        <email>mahdiye.khiabany@gmail.com</email>
        <affiliation>Boushehr University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Parental consent and their access to smartphones
Child's cooperation for clinical oral and dental examination</inclusion_criteria>
      <agemin>6 years</agemin>
      <agemax>16 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Use of medications that have oral side effects such as dry mouth
Presence of motor disorders and potential inability to brush teeth</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>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: A group that learns how to brush their teeth with an educational video</i_keyword>
      <i_keyword>Control group: A group that learns how to brush their teeth with flash cards</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Assessing oral hygiene status through oral hygiene index simplified measurement. Timepoint: The oral hygiene index simplified will be measured before the intervention, one  and tree month after the intervention. Method of measurement: Clinical oral examination and completion of the oral hygiene index simplified chart.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Children's oral health related behaviors. Timepoint: Before the intervention, one month and three months after the intervention. Method of measurement: A valid and reliable questionnaire that has previously been designed and used in a study by Dr. Piraneh and colleagues in the same field.</sec_outcome>
      <sec_outcome>Parents' knowledge and attitudes about oral health. Timepoint: Before the intervention, one month and three months after the intervention. Method of measurement: A valid and reliable questionnaire that has previously been designed and used in a study by Dr. Piraneh and colleagues in the same field.</sec_outcome>
      <sec_outcome>Child's cooperation during examination according to Frankl's classification. Timepoint: Before the intervention, one month and three months after the intervention. Method of measurement: Observing the child's behavior during the examination and recording the degree of cooperation according to Frankl's classification.</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>Boushehr University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-01-05</approval_date>
        <contact_name>Ethics committee of Bushehr university of medical Sciences</contact_name>
        <contact_address>Regional Secretariat of the Research Ethics Committee, Vice President for Research, First Floor, Medical Sciences Campus, Salman Farsi Street, Bahmani Bushehr Boushehr Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
