<?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>IRCT20130617013695N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-11-28</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Effect of education on prevention of traumatic dental injuries</public_title>
      <acronym></acronym>
      <scientific_title>The effect of two educational interventions on the knowledge and self-reported practice of 10-13-year-old elementary school students towards traumatic dental injuries</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-11-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>280</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66255</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: A list of girls' and boys' elementary schools covered by the Tehran University of Medical Sciences in Tehran will be prepared. From this list, two girls' primary schools and two boys' primary schools will be randomly selected as strata. Again, from the fourth to the sixth grades of each primary school, two classes will be defined as a cluster. Allocation of the intervention to these four primary schools will be done randomly and by a coin toss: in two primary schools (one for girls and one for boys) it will be in the form of educational flash cards and in the other two primary schools (one for girls and one for boys) it will be in the form of an educational application.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Traumatic dental injuries.</hc_freetext>
      <i_freetext>Intervention 1: The first intervention group: a package containing educational flash cards with color pictures regarding the prevention of dental injuries is prepared based on the latest evidence and scientific guidelines. This package has information for students in two parts: 1- Proper management of dental injuries after they occur, including soft tissue damage, crown fracture, tooth loss, dental avulsion, and alveolar bone fracture, and 2- Methods of preventing dental injuries in teenagers, including the use of mouth guard and its types. At baseline and after collecting filled-out questionnaires by participants, the educational flash cards will be distributed among participants in the flash card group. The flash cards will remain with the students. A month and a half after the flash cards distribution, a reminder will be sent again to the athletes as a reminder. Intervention 2: Intervention group 2: An educational application on prevention of Traumatic Dental Injuries (TDIs) in Android operating system, will be designed based on on the latest evidence and scientific guidelines with similar content to the pamphlet. As same as flash cards, the application provides information for students in two parts: 1- proper TDIs' management after occurrence including soft tissue damage, crown fracture, tooth luxation, tooth avulsion, and alveolar bone damage, and 2- preventive measurements on TDIs in sports including mouth guard usage and different types of this appliance. At baseline, after collecting filled out questionnaire by participants, the link to access the application in Miket, the Iranian application market, will be sent to the students or thier parents via SMS. Students will be asked to contact one of the study researchers if they have problems in installing or using the app. A month and a half after sending the link, a notification designed in the app will be sent to students as a reminder .</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:
After making people unrecognizable, the study protocol, information on the main outcomes (Knowledge and practice), informed consent form, and report of the study will be shareable.

When:
Initiation of access: from the publication of the manuscript

To whom:
Researchers in academic and scientific organizations; Education departments; Parents and students

Conditions:
Access to data and documents would be possible by sending a request email to the main researcher.

Where to obtain:
Sending email to Dr. Samaneh Razeghi (s-razeghi@tums.ac.ir)

How to obtain:
Sending email to Dr. Samaneh Razeghi (s-razeghi@tums.ac.ir)

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Samaneh Razeghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Dentistry, Tehran University of Medical Sciences, North Kargar Str.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1439955991</zip>
        <telephone>+98 21 8801 5960</telephone>
        <email>s-razeghi@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Samaneh Razeghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Dentistry, Tehran University of Medical Sciences, North Kargar Str.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1439955991</zip>
        <telephone>+98 21 8801 5960</telephone>
        <email>s-razeghi@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The age of the student was between 11 - 15 years old
The student or his/her parents have satisfied with participating in the study
The student or his/her parents have a cellphone with Android system</inclusion_criteria>
      <agemin>10 years</agemin>
      <agemax>13 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The student does not have the ability to understand the questionnaire questions
Parents or students do not want to participate in the study
The student does not have access to a smartphone</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S02.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Fracture of tooth</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The first intervention group: a package containing educational flash cards with color pictures regarding the prevention of dental injuries is prepared based on the latest evidence and scientific guidelines. This package has information for students in two parts: 1- Proper management of dental injuries after they occur, including soft tissue damage, crown fracture, tooth loss, dental avulsion, and alveolar bone fracture, and 2- Methods of preventing dental injuries in teenagers, including the use of mouth guard and its types. At baseline and after collecting filled-out questionnaires by participants, the educational flash cards will be distributed among participants in the flash card group. The flash cards will remain with the students. A month and a half after the flash cards distribution, a reminder will be sent again to the athletes as a reminder.</i_keyword>
      <i_keyword>Intervention group 2: An educational application on prevention of Traumatic Dental Injuries (TDIs) in Android operating system, will be designed based on on the latest evidence and scientific guidelines with similar content to the pamphlet. As same as flash cards, the application provides information for students in two parts: 1- proper TDIs' management after occurrence including soft tissue damage, crown fracture, tooth luxation, tooth avulsion, and alveolar bone damage, and 2- preventive measurements on TDIs in sports including mouth guard usage and different types of this appliance. At baseline, after collecting filled out questionnaire by participants, the link to access the application in Miket, the Iranian application market, will be sent to the students or thier parents via SMS. Students will be asked to contact one of the study researchers if they have problems in installing or using the app. A month and a half after sending the link, a notification designed in the app will be sent to students as a reminder .</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Changes in knowledge score gained by questionnaire. Timepoint: Measuring knowledge score at the baseline (before intervention) and three months after intervention. Method of measurement: Based on scores obtained from knowledge questions in the standardized questionnaire for assessing athletes' knowledge about traumatic dental injuries.</prim_outcome>
      <prim_outcome>Changes in self-reported practice score gained by questionnaire. Timepoint: Measuring self-reported practice score at the baseline (before intervention) and three months after intervention. Method of measurement: Based on scores obtained from self-reported practice questions in the standardized questionnaire for assessing athletes' self-reported practice about traumatic dental injuries.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-05-28</approval_date>
        <contact_name>Research Ethics Committees of School of Dentistry- Tehran University of Medical Sciences</contact_name>
        <contact_address>School of Dentistry, Tehran University of Medical Sciences,  North Kargar Street Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
