<?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>IRCT2016123131675N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-07-26</date_registration>
      <primary_sponsor>Vice chancellor for research, Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The application of social marketing to promote good habits of brushing (at least twice a day, each time at least two minutes)</public_title>
      <acronym></acronym>
      <scientific_title>The effect of two types of intervention (based on the principles of social marketing and traditional education) on increase in self-reported frequency and duration of tooth brushing of elementary school students: A controlled quasi-experimental study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-02-25</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>1720</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/24872</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Oral health advice and education (tooth brushing habit).</hc_freetext>
      <i_freetext>Intervention 1: Intervention in intervention city (Kahak city): The use of social marketing principles such as use of adware, masterclass, distributed toothbrushes, timers, brochures, etc. based on the assessed needs of students with using of SMART (Social marketing assessment and response tool) model in order to promote good habits of brushing (at least twice a day and each time at least two minutes). Intervention 2: Intervention in the control city (Jafariye city): The use of traditional methods such as distributing pamphlets to increase the frequency and duration of brushing.</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:
The total potential data can be shared after unidentifying people

When:
The start of access to data is 3 months after publishing the results

To whom:
Study data will be available to all individuals, including academic and industry researchers

Conditions:
Access to data will be available for oral health promotion programs and any statistical analysis will be allowed.

Where to obtain:
1. Dr Mahdia Gholami, Department of Community Oral Health, School of Dentistry, Tehran University of Medical Sciences, Tehran, Iran
Call Phone: +982188015960
Email: m_gholami@sina.tums.ac.ir

2. Dr. Ahmadreza Shamshiri- Department of Community Oral Health, School of Dentistry, Tehran University of Medical Sciences, Tehran, Iran
Call Phone: +982188015960
Email: ar_shamshiri@yahoo.com

How to obtain:
The requester must send the application to the persons mentioned in previous section to receive the study data. It is expected to receive information within a week.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Mahdia Gholami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Dentistry, after Energy-Atomi, North AmirAbad</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1439955934</zip>
        <telephone>+98 21 8801 5960</telephone>
        <email>m_gholami@sina.tums.ac.ir</email>
        <affiliation>Dentistry School of Teharan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mahdia Gholami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Dentistry, after Energy-Atomi, North AmirAbad</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1439955934</zip>
        <telephone>+98 21 8801 5960</telephone>
        <email>m_gholami@sina.tums.ac.ir</email>
        <affiliation>Dentistry School of Teharan 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>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Students enrolled in grades of one to six in elementary schools of Kahak and Jafariye cities in the academic year 2016-2017</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>non-compliance or lack of consent of the student or parents</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z72.9, Z71</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Problem related to lifestyle, unspecified---Other specified counselling</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention in intervention city (Kahak city): The use of social marketing principles such as use of adware, masterclass, distributed toothbrushes, timers, brochures, etc. based on the assessed needs of students with using of SMART (Social marketing assessment and response tool) model in order to promote good habits of brushing (at least twice a day and each time at least two minutes)</i_keyword>
      <i_keyword>Intervention in the control city (Jafariye city): The use of traditional methods such as distributing pamphlets to increase the frequency and duration of brushing</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Frequency of tooth brushing. Timepoint: Before and one month after intervention. Method of measurement: Answering checklist (self-reported).</prim_outcome>
      <prim_outcome>Duration of tooth brushing. Timepoint: Before and one month after intervention. Method of measurement: Answering checklist (self-reported).</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>Vice chancellor for research, Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-10-25</approval_date>
        <contact_name>Tehran University of Medical Sciences Ethics Committee</contact_name>
        <contact_address>room No. 604, sixth floor, the Central Organization of Tehran University of Medical Sciences, St. Qods, Keshavarz Blvd, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
