<?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>IRCT20221127056635N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-02-15</date_registration>
      <primary_sponsor>Semnan University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the differential learning effect of brushing children's teeth</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of effect of the differential learning of the horizontal scrub tooth brushing method on 6-9-year-old children’s skill problems</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-02-18</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67190</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: The differential learning method that was used in this study is as follows. Through 10 pre-recorded videos that show brushing in a horizontal scrub manner separately, (including the external/internal surfaces of each of the sextants) dental and occlusal surfaces) is presented to them, they are trained. These videos are sent to the parents separately and every day, and they are asked to send a video of the child's performance of that separation movement to the supervisor after watching the training video, and the supervisor will provide feedback on each child's skill errors. The child sends to the parents. Then the movements are requested in combination in each of the facial expressions and finally in the form of the entire facial expressions, Randomization description: In the first stage, we extract the necessary number of samples from the community of children aged 6-9 in Semnan schools through random cluster sampling (separately for girls' and boys' schools and different grades) and divide these children into three categories. We divide them into groups (three people in each group are matched in terms of age and sex). Then, using blocks of three, we divide each class into three groups (A, B, C). In fact, in each block of three, one person is assigned to group A, one person to group B, and one person to group C. The number of possible triple blocks is 6 (ABC, ACB, BAC, BCA, CAB, CBA). Block selection from six blocks and choosing which group A, B, and C are will be done using a table of random numbers.</study_design>
      <phase>2</phase>
      <hc_freetext>oral hygiene.</hc_freetext>
      <i_freetext>Intervention 1: The educational video is sent to the parents through the virtual space, and the children are given toothbrushes and toothpaste suitable for the age group in the school, and their parents are asked to send the video of the child brushing teeth to the supervisor every day after watching the educational video. Every night, the supervisor provides feedback on the child's skill errors to the parents of this group. Intervention 2: They are trained by 10 pre-recorded videos that present brushing in a horizontal scrub manner separately (including external/internal surfaces of each dental sextant and occlusal surfaces). These videos are sent to the parents separately and every day, and they are asked to send a video of the child's execution of the separation movement to the supervisor after watching the educational video, and the supervisor gives feedback on the skill errors of each child to the parents. he sends. Then the movements are requested in combination in each of the facial expressions and finally in the form of the entire facial expressions.</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:
Personal data of participants can be shared after de-identification.

When:
The access period starts 12 months after the publication of the results.

To whom:
researchers working in academic and scientific institutions

Conditions:
The use of statistical analysis on the data of this study is not allowed.

Where to obtain:
Parmida Aryanpour/dentistry university of semnan/09120048950/parmidaaryanpour2021@gmail.com

How to obtain:
The request of people who are eligible to receive data should be sent to parmida aryanpour by email.
parmidaaryanpour2021@gmail.com

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>ParmidaAryanpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>17 Shahrivar boulevard</address>
        <city>semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3519617645</zip>
        <telephone>+98 912 004 8950</telephone>
        <email>parmidaaryanpour@gmailcom</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyede Fatemeh Pachenari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>17 Shahrivar boulevard</address>
        <city>semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3519617645</zip>
        <telephone>+98 911 319 3019</telephone>
        <email>pachenari.dds@gmail.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Systemically healthy children;
The child's mastery of understanding and speaking in Persian language
Access to virtual space and softwares considered in the study
A guardian who has the power to supervise and participate in the plan for the period of time.</inclusion_criteria>
      <agemin>6 years</agemin>
      <agemax>9 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>physical/mental disabilities of the child or guardian;
Children's sensitivity to toothpaste;
The child's non-cooperation in implementing the plan's instructions;
Dental pain or infection requiring immediate 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>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The educational video is sent to the parents through the virtual space, and the children are given toothbrushes and toothpaste suitable for the age group in the school, and their parents are asked to send the video of the child brushing teeth to the supervisor every day after watching the educational video. Every night, the supervisor provides feedback on the child's skill errors to the parents of this group.</i_keyword>
      <i_keyword>They are trained by 10 pre-recorded videos that present brushing in a horizontal scrub manner separately (including external/internal surfaces of each dental sextant and occlusal surfaces). These videos are sent to the parents separately and every day, and they are asked to send a video of the child's execution of the separation movement to the supervisor after watching the educational video, and the supervisor gives feedback on the skill errors of each child to the parents. he sends. Then the movements are requested in combination in each of the facial expressions and finally in the form of the entire facial expressions.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The amount of changes in the gingival bleeding index. Timepoint: Assessment of skill problems on a daily basis/Evaluation of the gingival bleeding index at the beginning of the study, on the 30th day and the 60th day from the beginning of the study. Method of measurement: wHO probe.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The amount of changes in the gingival bleeding index. Timepoint: Evaluation of skill problems on a daily basis / evaluation of the gingival bleeding index at the beginning of the study, on the 30th day and the 60th day from the beginning of the study. Method of measurement: by gingival probing.</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>Semnan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-10-24</approval_date>
        <contact_name>ethics committee of semnan university medical science</contact_name>
        <contact_address>17 Shahrivar Boulevard; dentistry university سمنان Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
