<?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>IRCT20200208046413N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-07-05</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of an oral hygiene educational intervention to improve the oral health of elementary students with autism</public_title>
      <acronym></acronym>
      <scientific_title>Designing and evaluation of an oral hygiene educational intervention to improve the oral health of elementary students (aged 6-15yrs) with autism spectrum disorders</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-05-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/47392</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>Oral hygiene.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  1- Teaching children how to brush their teeth with Fonnes technique through video: A CD containing a short film that teaches children with ASD, method of brushing with fonnes technique in a  simple and understandable way, is designed and distributed. In it, a 10-year-old child is brushing his teeth and every part of his mouth that he brushes a Voice describes it behind the scenes with simple sentences and slow speed. The video file is provided to the parents of the intervention group through the WhatsApp social network and they are asked to play it to their children every day. 2- Educational session for the parents of the students: In each of the schools with Previous coordination with the school principal we ask students' parents to attend a group meeting. Speech with slides by a researcher for 15 minutes with the content of importance, prevalence, etiology and control of oral diseases including gum disease, caries and ways to deal with it, including nutritional recommendations and plaque control will take place. The brushing tutorial video is also shown to the audience, and the Fonnes brushing technique is taught to parents to monitor their child's brushing at home. A illustrated poster is then given to parents on how to brush properly to install on the wall of  their bathroom at home to help the child brush properly. Parents are also asked to introduce conditions of the examination day to  their children one week before the next clinical examination, through the social story given to them in the pre-intervention stage. 3- Teacher training session: Teachers  also are taught how to brush  with Fonnes Technic. And they are asked to show their students how to brush twice a week with a three-dimensional toothbrush and mouth model, and then accompany them to brush with their friends in the school environment. 4- Reminding and motivating Twice a week: a reminder is sent to parents of children through the WhatsApp social network. Intervention 2: Control group:  1- A written guide in the form of a pamphlet containing information similar to the face-to-face meeting held in the intervention group is presented to the parents. 2- The social story on the subject of brushing with Fonnes technique is given to the parents of this group and they are asked to work on this social story at home with their child. 3. A reminder message will be sent to them twice a week, similar to the intervention group through whats App social network.</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:
All potential data can be shared after people have not been identified

When:
Start the access period 3 to 6 months after publishing the results

To whom:
Researchers and people working in the field of education or industry can apply for data.

Conditions:
Any statistical use and analysis is permitted for the purpose of promoting oral health in people with autism.

Where to obtain:
See Dr. Hedyeh Piraneh Haghighi Bonab
Address: Department of Community Oral Health, Faculty of Dentistry of Tehran University of medical sciences, End of North kargar,Tehran, Iran. 
Postal Code: 1439955991
Email: h.piraneh@yahoo.com
Mobile: 00989058873546

How to obtain:
The applicant can send his / her details and the organization in which he / she works and the exact details and purpose of his / her request via e-mail. Finally, the response will be done within a week.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hedieh Piraneh Haghighi Bonab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Dentistry of Tehran University of Medical Sciences, End of North Kargar St.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۴۳۹۹۵۵۹۹۱</zip>
        <telephone>+98 21 7279 4175</telephone>
        <email>h.piraneh@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hedieh Piraneh Haghighi Bonab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Dentistry of Tehran University of Medical Sciences, End of North Kargar St.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۴۳۹۹۵۵۹۹۱</zip>
        <telephone>+98 21 7279 4175</telephone>
        <email>h.piraneh@yahoo.com</email>
        <affiliation>Tehran 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>Informed consent of parents
The students should be at first to sixth grade of elementary school
Age of the student should be 6 to 15 years old
Including only ASD Level 1 and 2
Family should have access to the WhatsApp social network.</inclusion_criteria>
      <agemin>6 years</agemin>
      <agemax>15 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Participants with other disabilities.
participants who are unable to cooperate. (Because of stress, panic attacks, fainting history, etc.)</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>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:  1- Teaching children how to brush their teeth with Fonnes technique through video: A CD containing a short film that teaches children with ASD, method of brushing with fonnes technique in a  simple and understandable way, is designed and distributed. In it, a 10-year-old child is brushing his teeth and every part of his mouth that he brushes a Voice describes it behind the scenes with simple sentences and slow speed. The video file is provided to the parents of the intervention group through the WhatsApp social network and they are asked to play it to their children every day. 2- Educational session for the parents of the students: In each of the schools with Previous coordination with the school principal we ask students' parents to attend a group meeting. Speech with slides by a researcher for 15 minutes with the content of importance, prevalence, etiology and control of oral diseases including gum disease, caries and ways to deal with it, including nutritional recommendations and plaque control will take place. The brushing tutorial video is also shown to the audience, and the Fonnes brushing technique is taught to parents to monitor their child's brushing at home. A illustrated poster is then given to parents on how to brush properly to install on the wall of  their bathroom at home to help the child brush properly. Parents are also asked to introduce conditions of the examination day to  their children one week before the next clinical examination, through the social story given to them in the pre-intervention stage. 3- Teacher training session: Teachers  also are taught how to brush  with Fonnes Technic. And they are asked to show their students how to brush twice a week with a three-dimensional toothbrush and mouth model, and then accompany them to brush with their friends in the school environment. 4- Reminding and motivating Twice a week: a reminder is sent to parents of children through the WhatsApp social network.</i_keyword>
      <i_keyword>Control group:  1- A written guide in the form of a pamphlet containing information similar to the face-to-face meeting held in the intervention group is presented to the parents. 2- The social story on the subject of brushing with Fonnes technique is given to the parents of this group and they are asked to work on this social story at home with their child. 3. A reminder message will be sent to them twice a week, similar to the intervention group through whats App social network.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Oral hygiene status. Timepoint: before intervention, 30 days after the intervention and 3 Months later. Method of measurement: Simplified-Oral-Hygiene-Index.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Dental caries prevention research center</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Tehran University of Medical Sciences</source_name>
      <source_name>Dental caries prevention research center</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-12-08</approval_date>
        <contact_name>Ethics committee of School of Dentistry- Tehran University of Medical Sciences</contact_name>
        <contact_address>School of Dentistry of Tehran University of Medical Sciences, Adjacent to the Atomic Energy Organization, End of North Kargar S.t, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
