<?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>IRCT20090429001861N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-06-15</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>the influence of two methods of Visual Pedagogy on Tooth-brushing autonomy in  Autistic Children</public_title>
      <acronym></acronym>
      <scientific_title>Comparison between the influence of two methods of Visual Pedagogy, namely Poster and Educational Movie, on Tooth-brushing autonomy in 10-12-year-old Autistic Children</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-05-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53690</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Children will be divided into two groups by permuted randomization block method. First, they will be specified to quadruple blocks, which randomly contain two a (poster) and two b(film). Randomization will take place by the methodologist who is not involved with the execution of the study. The examiner will not be informed about the randomization process. The whole process will occur with the aid of the rand option of the Excel software. With the rand option of this software 4 numbers are generated. the two firsts are assigned to a and the two seconds are assigned to b. then they are ranked from the highest to the lowest, forming a block. This process will be repeated 16 times until all of the blocks are formed. After the specification of the samples, information will be handed to the examiner in 64 closed envelopes. The examiner will open each envelope according to the sample codes, after the first evaluation, Blinding description: The evaluator and data analyzer were Blinded.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Autistic disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Before any intervention, the toothbrushing performance will be observed and recorded. Then, a muted educational movie will be delivered to parents. The film should be viewed once before the brushing procedure. To avoid child distraction, unnecessary information is not given to children through this film. Since autistic children desire to repeat the tasks, they are allowed to watch the film as many times as they desire. To help the child to distinguish better, a blue toothbrush is used for the upper jaw and a red one for the lower jaw. Furthermore, the teacher's attire will be white; and the film will be muted for better concentration of the child.  Tooth brushing is demonstrated by one of the teachers. The FONES brushing technique will be taught. Toothbrushing will be performed under the supervision of parents. Toothbrushes and toothpaste are given to study participants by a responsible investigator. The method of toothbrushing also is trained to parents for comprehensive supervision. The toothbrushing procedure will be divided into 5 stages including 24 steps as following: Stage one, preparation including, 1: taking the toothbrush, 2: opening the toothpaste, 3: pressing the toothpaste, 4: putting toothpaste on the toothbrush, 5: closing the toothpaste cap. Stage two, brushing the occlusal surfaces in 4 quadrants including, 6: upper left, 7: upper right, 8: lower left, 9:  lower right. Stage three brushing the buccal surfaces including,10:upper right, 11: upper anterior teeth, 12: upper right, 13: lower right, 14: lower anterior, 15: lower left. The fifth stage is the end of brushing, including; 22: rinsing the mouth, 23: cleaning the brush, 24: putting the brush in its place. The performance of toothbrushing will be evaluated after one and three months by a blinded investigator. Intervention 2: Control group: An educational poster will be placed where the kid brush his-her teeth. The poster included 24 steps of toothbrushing in 16 pictures. The FONES model of toothbrushing will be instructed. The pictures are provided according to a human model with white background. The child may see the pictures as many times as he/she wants.</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:
Film: The recorded videos' of toothbrushing steps can be shared as the outcome.

When:
Starting 6 months after publication

To whom:
The documents will be shared only to the publisher, and does not available for public use.

Conditions:
Any academic usage should be with the collaboration of main authors.

Where to obtain:
1.Katayoun Salem
Tehran Azad Dental school, Department of Pediatric Dentistry, 9th Neyestan, Pasdaran, Tehran
cell: 0098 9122174076
email: katayoun.salem@gmail.com
2. Rojin Adabdokht
Tehran Azad Dental school, Department of Pediatric Dentistry, 9th Neyestan, Pasdaran, Tehran
cell: 0098912 2349907
rojinadabdokht@gmail.com

How to obtain:
The documents will be available after publishing, and to receive the documents for reappraisal of results,  the request should be sent to responsible author.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Katayoun Salem</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad Dental School.No.9, 9th Neyestan Ave., Pasdaranestan, Pasdaran,</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1946853314</zip>
        <telephone>0098 21 22564571/3</telephone>
        <email>katatyoun.salem@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Katayoun Salem</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 9, 9th Neyestan Ave., Pasdaran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1946853314</zip>
        <telephone>0098 21 22564571/3</telephone>
        <email>katayoun.salem@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Mild Autism
Age between 10-12 years
Parental motivation to cooperate</inclusion_criteria>
      <agemin>10 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Other Systemic diseases
other Mental disability</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F84.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Autistic disorder</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: Before any intervention, the toothbrushing performance will be observed and recorded. Then, a muted educational movie will be delivered to parents. The film should be viewed once before the brushing procedure. To avoid child distraction, unnecessary information is not given to children through this film. Since autistic children desire to repeat the tasks, they are allowed to watch the film as many times as they desire. To help the child to distinguish better, a blue toothbrush is used for the upper jaw and a red one for the lower jaw. Furthermore, the teacher's attire will be white; and the film will be muted for better concentration of the child.  Tooth brushing is demonstrated by one of the teachers. The FONES brushing technique will be taught. Toothbrushing will be performed under the supervision of parents. Toothbrushes and toothpaste are given to study participants by a responsible investigator. The method of toothbrushing also is trained to parents for comprehensive supervision. The toothbrushing procedure will be divided into 5 stages including 24 steps as following: Stage one, preparation including, 1: taking the toothbrush, 2: opening the toothpaste, 3: pressing the toothpaste, 4: putting toothpaste on the toothbrush, 5: closing the toothpaste cap. Stage two, brushing the occlusal surfaces in 4 quadrants including, 6: upper left, 7: upper right, 8: lower left, 9:  lower right. Stage three brushing the buccal surfaces including,10:upper right, 11: upper anterior teeth, 12: upper right, 13: lower right, 14: lower anterior, 15: lower left. The fifth stage is the end of brushing, including; 22: rinsing the mouth, 23: cleaning the brush, 24: putting the brush in its place. The performance of toothbrushing will be evaluated after one and three months by a blinded investigator.</i_keyword>
      <i_keyword>Control group: An educational poster will be placed where the kid brush his-her teeth. The poster included 24 steps of toothbrushing in 16 pictures. The FONES model of toothbrushing will be instructed. The pictures are provided according to a human model with white background. The child may see the pictures as many times as he/she wants.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Autonomy score. Timepoint: Before the intervention, one month after the beginning of visual pedagogy, three months after the beginning of visual pedagogy. Method of measurement: Observation and filling the template for measuring the autonomy, designed based on the Lopez study. The template has no specific name. https://doi.org/10.1007/s40368-018-0396-y.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-01-02</approval_date>
        <contact_name>Ethics committee of Islamic Azad University of Medical science</contact_name>
        <contact_address>No. 9, 9th Nezestan Alley, Pasdaran Ave Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
