<?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>IRCT20141128020129N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-10-18</date_registration>
      <primary_sponsor>Hamedan University of Medical Sciences</primary_sponsor>
      <public_title>Effect of health educational program on promoting oral health among elementary school students</public_title>
      <acronym></acronym>
      <scientific_title>Effect of health educational program on promoting oral health among elementary school students: Developing an educational model</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-03-08</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>190</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/17863</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: . In this study, subjects were selected by multistage cluster sampling. The ministry of education classifies Hamadan into two educational regions (region one and region two). First, three girls’ schools were randomly selected (each school in one of the privileged, semi-privileged, and unprivileged areas) from each educational region based on the health care availability rate. Afterward, one fifth-grade class was selected from the list of classes of each school using simple random sampling. In the end, the schools were randomly allocated to intervention and control groups after the primary evaluation of the level of plaque, gum health, oral and dental health status, and completing the questionnaire. In total, while each group of intervention and control was allocated 102 students, seven participants were removed from each group due to incomplete pretest and post-test questionnaires and the parent's lack of cooperation.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Dental Calculus and Debris. Condition 2: Periodontal diseases.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The education program in this study included one education session for mothers and 10 education sessions for students. In the education session for mothers, tips were presented about the importance of oral health and its role in the general health, and the goals and implementation of the intervention program.Interventions in students were done through the game method and with the help of 7 educational videos, 3 pamphlets, 5 posters, role playing, holding a health and oral health celebration and forming a telegram group.Students were trained in the following areas: familiarizing students with tooth structure and periodontal structure, knowledge of oral and dental diseases (decay and periodontal diseases) and their causes, ways to prevent oral and dental diseases. In order to remind students to practice oral and dental hygiene behaviors, daily brushing and flossing records were provided to the students. In order to investigate the oral  hygiene behaviors of the students at home, the researcher checked the forms of the students once a week in each class. A group called "Oral Health" was created on Telegram and family members of students, teachers and administrators of each school, professor of social dentistry and health education joined this group. The educational videos that were played in the classes in every session, educational materials related to oral health were uploaded in the group and the questions of the members were answered about issues related to oral health. Students were asked to take pictures of themselves while brushing and flossing and post them in the group. The educational intervention ended with the celebration of oral health in each school. The parents of the students participated in the celebration held in the school. In this ceremony, students performed their shows for parents, principal and school teacher. Intervention 2: Control group: They received routine programs and training at 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:
Samane Shirahmadi emails

How to obtain:
After checking the requester's email by Samane Shirahamdi, 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>Samane Shirahmadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Community Oral Health, School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh St., PaJuhesh square</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۶۵۱۷۸۳۸۷۳۶</zip>
        <telephone>+98 81 3838 1059</telephone>
        <email>s.shirahmadi@umsha.ac.ir</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Samane Shirahmadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Community Oral Health, School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh St., PaJuhesh square</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۶۵۱۷۸۳۸۷۳۶</zip>
        <telephone>+98 81 3838 1059</telephone>
        <email>s.shirahmadi@umsha.ac.ir</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>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>Being 11-12 years old
being a girl
student's consent to participate in the study
parents' consent to their child's participation in the study</inclusion_criteria>
      <agemin>11 years</agemin>
      <agemax>12 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having systemic diseases,
Having Oral Mucosal Lesions,
Having orthodontics,
Needing any emergency dental treatment</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K03.6</hc_code>
      <hc_code>K05</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Deposits [accretions] on teeth</hc_keyword>
      <hc_keyword>Gingivitis and periodontal diseases</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: The education program in this study included one education session for mothers and 10 education sessions for students. In the education session for mothers, tips were presented about the importance of oral health and its role in the general health, and the goals and implementation of the intervention program.Interventions in students were done through the game method and with the help of 7 educational videos, 3 pamphlets, 5 posters, role playing, holding a health and oral health celebration and forming a telegram group.Students were trained in the following areas: familiarizing students with tooth structure and periodontal structure, knowledge of oral and dental diseases (decay and periodontal diseases) and their causes, ways to prevent oral and dental diseases. In order to remind students to practice oral and dental hygiene behaviors, daily brushing and flossing records were provided to the students. In order to investigate the oral  hygiene behaviors of the students at home, the researcher checked the forms of the students once a week in each class. A group called "Oral Health" was created on Telegram and family members of students, teachers and administrators of each school, professor of social dentistry and health education joined this group. The educational videos that were played in the classes in every session, educational materials related to oral health were uploaded in the group and the questions of the members were answered about issues related to oral health. Students were asked to take pictures of themselves while brushing and flossing and post them in the group. The educational intervention ended with the celebration of oral health in each school. The parents of the students participated in the celebration held in the school. In this ceremony, students performed their shows for parents, principal and school teacher.</i_keyword>
      <i_keyword>Control group: They received routine programs and training at school.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Percentage of people who brushed twice a day with a toothpaste containing fluoride. Timepoint: Before the start of the study, immediately after the end of the intervention, three months after the end of the intervention. Method of measurement: Standard questionnaire.</prim_outcome>
      <prim_outcome>Use dental floss at least once a day. Timepoint: Before the start of the study, immediately after the end of the intervention, three months after the end of the intervention. Method of measurement: Standard questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The percentage of dental plaque in each person. Timepoint: Before the start of the study, immediately after the end of the intervention, three months after the end of the intervention. Method of measurement: Clinical examination by a dentist.</sec_outcome>
      <sec_outcome>Determining the rate of periodontal tissue health of each person. Timepoint: Before the start of the study, immediately after the end of the intervention, three months after the end of the intervention. Method of measurement: Clinical examination by a dentist.</sec_outcome>
      <sec_outcome>Determining the rate of dental debris and calculus in each person. Timepoint: Before the start of the study, immediately after the end of the intervention, three months after the end of the intervention. 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>2016-02-13</approval_date>
        <contact_name>The 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>
