<?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>IRCT20231231060582N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-01-26</date_registration>
      <primary_sponsor>Birjand University of Medical Sciences</primary_sponsor>
      <public_title>Effects of health education on oral and dental health</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effectiveness of oral and dental health education by video and face-to-face methods on the level of oral and dental health indicators and child cooperation in 6-12-year-old students with autism spectrum disorders</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>65</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/74777</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance.</study_design>
      <phase>N/A</phase>
      <hc_freetext>autism spectrum disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In order to carry out the intervention in the video intervention group, an educational video about self-care skills will be delivered to the patient. The content of educational videos will be designed under the supervision and guidance of a group of experts according to the objectives of the study and will be provided to the instructors of this group. Educators will be asked to play video content for children three times a week according to the designed educational program and make sure that the child sees the video content. Also, the child will be asked to repeat the movements step by step along with the video. The families will be asked to install the reminder educational poster in front of the child during the implementation of oral and dental care techniques at home and to monitor the requirement every night while brushing teeth at home according to the principles stated in the pamphlet. Intervention 2: Intervention group 2: In the face-to-face training group, before starting the study, the instructors will be taught the correct way of brushing teeth in certain children based on valid references by the researcher. children will receive oral and dental self-care educations three times a week according to the designed educational program. In this group, along with the teacher, children will learn brushing movements in front of the mirror and repeat it step by step. The same educational poster as the other group will be provided to this group as well. Also, like the video training group, parents should monitor and accompany the child during all stages of oral and dental self-care.</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:
Comparing the effectiveness of oral and dental health education by video and face-to-face methods on the level of oral and dental health indicators and child cooperation in 6-12-year-old students with autism spectrum disorders

When:
Not decided yet

To whom:
People working in academic institutions and parents of children with autism

Conditions:
Not decided yet

Where to obtain:
Responsible persons:
Sahar Ebrahimi                   sahar_ebrahimi@yahoo.com
Dr. Mehrnaz Khademi            mehr.kh6688@yahoo.com

How to obtain:
The applicant must send his request for information or data to the email address of the respondents within 6 months after completing and analyzing the results. Requests will be processed after the results are published in scientific articles.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mehrnaz Khademi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Birjand University of Medical Sciences , Ghafari Street, Birjand, South Khorasan, Iran.</address>
        <city>Birjand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9717853577</zip>
        <telephone>+98 56 3239 5696</telephone>
        <email>mehr.kh6688@yahoo.com</email>
        <affiliation>Birjand University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mehrnaz Khademi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Birjand University of Medical Sciences , Ghafari Street, Birjand, South Khorasan, Iran.</address>
        <city>Birjand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9717853577</zip>
        <telephone>+98 56 3239 5696</telephone>
        <email>mehr.kh6688@yahoo.com</email>
        <affiliation>Birjand University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 6-12 years old
Patients on mild to moderate stage of autism spectrum disorders
Signing consent form by parents</inclusion_criteria>
      <agemin>6 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The existence of other physical or developmental or mental disabilities and inability to cooperate with the patient
The unwillingness of the child or her/his parents to participate or continue the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F84.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>autism spectrum disorder, oral health, education</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In order to carry out the intervention in the video intervention group, an educational video about self-care skills will be delivered to the patient. The content of educational videos will be designed under the supervision and guidance of a group of experts according to the objectives of the study and will be provided to the instructors of this group. Educators will be asked to play video content for children three times a week according to the designed educational program and make sure that the child sees the video content. Also, the child will be asked to repeat the movements step by step along with the video. The families will be asked to install the reminder educational poster in front of the child during the implementation of oral and dental care techniques at home and to monitor the requirement every night while brushing teeth at home according to the principles stated in the pamphlet.</i_keyword>
      <i_keyword>Intervention group 2: In the face-to-face training group, before starting the study, the instructors will be taught the correct way of brushing teeth in certain children based on valid references by the researcher. children will receive oral and dental self-care educations three times a week according to the designed educational program. In this group, along with the teacher, children will learn brushing movements in front of the mirror and repeat it step by step. The same educational poster as the other group will be provided to this group as well. Also, like the video training group, parents should monitor and accompany the child during all stages of oral and dental self-care.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Tooth decay. Timepoint: At the beginning of the study (before the start of the intervention) and after the intervention. Method of measurement: Based on dmft index.</prim_outcome>
      <prim_outcome>Children's cooperation index. Timepoint: At the beginning of the study (before the start of the intervention) and after the intervention. Method of measurement: Based on the Frankel Index.</prim_outcome>
      <prim_outcome>The frequency of using a toothbrush. Timepoint: At the beginning of the study (before the start of the intervention) and after the intervention. Method of measurement: Based on the number of times they brush their teeth.</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>Birjand University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-10-09</approval_date>
        <contact_name>Ethics committee of Birjand University of Medical Sciences</contact_name>
        <contact_address>Birjand University of Medical Sciences , Ghafari Street, Birjand, South Khorasan, Iran. Birjand South Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
