<?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>IRCT20230313057708N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-04-25</date_registration>
      <primary_sponsor>Hamedan University of Medical Sciences</primary_sponsor>
      <public_title>Effect of application in promotion of oral health</public_title>
      <acronym></acronym>
      <scientific_title>Designing, implementing and evaluating a virtual educational program to promote the oral  health of 12-year-old students</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-04-25</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>168</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69160</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: The sampling method in this study is a multi-stage cluster. Sampling will be done using a table of random number. For this purpose, the list of all primary schools for girls and boys will be received from education department of Hamadan city and each school will be given a two-digit code (code 01 to 57 for boy's schools and code 01 to 68 for girl's schools). To select girl's schools, refer to the table of random numbers and the starting point will be selected. The starting point will be done by closing the eyes and placing a finger or the tip of the pen on the table.Then, based on adjacent two-digit numbers, it will move in the direction of the line. In this path, two types of numbers are encountered, one of which is smaller than the total number of girl's schools and the other is larger than the number of schools. Only smaller numbers will be selected for sampling. The selected number is actually the school code that is selected as a sample. The first number will be considered as intervention school 1, the second number will be intervention school 2 and the third number will be considered as control school. After completing the sampling of girl's schools, the same will be repeated for the selection of boy's schools.
In order to select the classes, one class will be selected from the list of sixth grade classes in each school using a  table of random numbers (like the method of choosing schools) and all students of that class will enter the study based on having the inclusion and exclusion criteria.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Oral Health.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: The educational program in this group will be using the mobile application. Application design sessions will be held face-to-face and virtually with the participation of dental professors and student, software engineers and a number of 12-year-old students. In this application, 10 educational programs will be placed and students can use its contents during one month. Students will be trained in the following topics: the importance of oral hygiene, familiarity with tooth structure and periodontal structure, awareness of oral and dental diseases (decay and periodontal diseases) and their causes, ways to prevent oral and dental diseases. Also, in this application, students will be able to ask their questions about oral and dental health issues and they will be answered. Also, a brochure will be prepared for mothers, which will provide tips on the importance of oral hygiene and its role in public health, and the goals and implementation of the intervention program. Intervention 2: Intervention group 2: The educational program in this group will include 6 face-to-face training sessions for students during a month. Also, a brochure will be prepared for mothers, which will provide tips on the importance of oral hygiene and its role in public health, and the goals and implementation of the intervention program. Interventions in students will be done with 10 educational videos. Students will be trained in the following topics: the importance of oral hygiene, familiarity with tooth structure and periodontal structure, awareness of oral and dental diseases (decay and periodontal diseases) and their causes, ways to prevent oral and dental diseases. A group called "Oral Health" will be created in Rubika messenger and the members of this group will consist of students, their families, teachers and principals of each school, professor of social dentistry and dental student. In this group, member's questions about oral health issues will be answered. Intervention 3: Control group: Receive routine programs and training in school.</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 data is potentially shareable after de-identifying individuals

When:
The access period starts 6 months after the results are published

To whom:
The data will be available only to researchers working in academic and scientific institutions

Conditions:
People who intend to use the study data for review articles and meta-analysis

Where to obtain:
Zeinab Mosayebi emails

How to obtain:
After checking the requester's email by Zeinab Mosayebi, if the conditions are met, the data will be sent to them 3 days later.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zeinab Mosayebi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Dentistry, Hamedan University of Medical Science, Shahid Fahmide Blvd.</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۶۵۱۷۸۳۸۸۴۳</zip>
        <telephone>+98 81 3838 1059</telephone>
        <email>zm.mosayebi@yahoo.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zeinab Mosayebi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Dentistry, Hamedan University of Medical Science, Shahid Fahmide Blvd.</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۶۵۱۷۸۳۸۸۴۳</zip>
        <telephone>+98 81 3838 1059</telephone>
        <email>zm.mosayebi@yahoo.com</email>
        <affiliation>Hamedan 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></country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>12 years old
Eruption of all permanent teeth
Having an android phone or tablet
Willingness to participate in study
Parental consent</inclusion_criteria>
      <agemin>12 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having an orthodontic appliance
Having Oral Mucous Lesions
Needing any emergency dental treatment
Having movement restriction</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>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: The educational program in this group will be using the mobile application. Application design sessions will be held face-to-face and virtually with the participation of dental professors and student, software engineers and a number of 12-year-old students. In this application, 10 educational programs will be placed and students can use its contents during one month. Students will be trained in the following topics: the importance of oral hygiene, familiarity with tooth structure and periodontal structure, awareness of oral and dental diseases (decay and periodontal diseases) and their causes, ways to prevent oral and dental diseases. Also, in this application, students will be able to ask their questions about oral and dental health issues and they will be answered. Also, a brochure will be prepared for mothers, which will provide tips on the importance of oral hygiene and its role in public health, and the goals and implementation of the intervention program.</i_keyword>
      <i_keyword>Intervention group 2: The educational program in this group will include 6 face-to-face training sessions for students during a month. Also, a brochure will be prepared for mothers, which will provide tips on the importance of oral hygiene and its role in public health, and the goals and implementation of the intervention program. Interventions in students will be done with 10 educational videos. Students will be trained in the following topics: the importance of oral hygiene, familiarity with tooth structure and periodontal structure, awareness of oral and dental diseases (decay and periodontal diseases) and their causes, ways to prevent oral and dental diseases. A group called "Oral Health" will be created in Rubika messenger and the members of this group will consist of students, their families, teachers and principals of each school, professor of social dentistry and dental student. In this group, member's questions about oral health issues will be answered.</i_keyword>
      <i_keyword>Control group: Receive routine programs and training in school.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Knowledge: Having knowledge in the field of oral and dental health. Timepoint: At the beginning of the study and 12 weeks later. Method of measurement: Knowledge standard questionnaire.</prim_outcome>
      <prim_outcome>Percentage of people who brushed twice a day with a toothpaste containing fluoride. Timepoint: At the beginning of the study and 12 weeks later. Method of measurement: Behavior standard questionnaire.</prim_outcome>
      <prim_outcome>Use dental floss at least once a day. Timepoint: At the beginning of the study and 12 weeks later. Method of measurement: Behavior standard questionnaire.</prim_outcome>
      <prim_outcome>Mouthwash use. Timepoint: At the beginning of the study and 12 weeks later. Method of measurement: Behavior standard questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The percentage of dental plaque in each person. Timepoint: At the beginning of the study and 12 weeks later. Method of measurement: Clinical examination by a dentist.</sec_outcome>
      <sec_outcome>Determining the rate of periodontal tissue health of each person. Timepoint: At the beginning of the study and 12 weeks later. Method of measurement: Clinical examination by a dentist.</sec_outcome>
      <sec_outcome>Determining the rate of dental debris and calculus in each person. Timepoint: At the beginning of the study and 12 weeks later. Method of measurement: Clinical examination by a dentist.</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>Hamedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-03-04</approval_date>
        <contact_name>Ethics committee of Hamadan University of Medical Sciences</contact_name>
        <contact_address>4th floor, Headquarters of the University of Medical Sciences, Shahid Fahmideh St., PaJuhesh square Hamadan Hamadan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
