<?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>IRCT20130617013695N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-04-22</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>To determine the effect of two types of educational interventions including pamphlet and mobile application on traumatic dental injuries on the knowledge and self-reported performance of marital arts athletes aged 11-15 years</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-08-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>92</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49379</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: From the list of martial arts clubs provided by the Sports Medicine Federation, two clubs with athletes of both sexes will be randomly selected as clusters using a random number table. From the list of athletes in each club and based on the gender, two strata will be defined. Using a table of random numbers, 23 boys and 23 girls (46 people in total) will be selected. The allocation of intervention to these two clubs will be done randomly by flipping a coin; so that one club will receive an educational pamphlet and the other club will receive an educational application.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Traumatic dental injuries.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: An educational colorful pamphlet on prevention of Traumatic Dental Injuries (TDIs) will be designed based on on the latest evidence and scientific guidelines. This pamphlet provides information for athletes in two parts: 1- preventive measurements on TDIs in sports including mouth guard usage and different types of this appliance, and 2- proper TDIs' management after occurrence including soft tissue damage, crown fracture, tooth luxation, tooth avulsion, and alveolar bone damage. At baseline and after collecting filled out questionnaires by participants, the educational pamphlet will be distributed among participants in pamphlet group. The pamphlets will remain with the athletes. A month and a half after the first pamphlet, the same pamphlet 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 pamphlet, the application provides information for athletes in two parts: 1- preventive measurements on TDIs in sports including mouth guard usage and different types of this appliance, and 2- proper TDIs' management after occurrence including soft tissue damage, crown fracture, tooth luxation, tooth avulsion, and alveolar bone damage. 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 athletes via WhatsApp. Athletes 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 athletes 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, 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;
Athletes

Conditions:
access to data and documents would be possible through sending 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 participant should practice in one of the martial arts
The age of the athlete was between 11 - 15 years old
The athlete or his/her parents have satisfied with participating in the study
The athlete or his/her parents have a cellphone with Android system</inclusion_criteria>
      <agemin>11 years</agemin>
      <agemax>15 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S02.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Fracture of tooth (traumatic)</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 1: An educational colorful pamphlet on prevention of Traumatic Dental Injuries (TDIs) will be designed based on on the latest evidence and scientific guidelines. This pamphlet provides information for athletes in two parts: 1- preventive measurements on TDIs in sports including mouth guard usage and different types of this appliance, and 2- proper TDIs' management after occurrence including soft tissue damage, crown fracture, tooth luxation, tooth avulsion, and alveolar bone damage. At baseline and after collecting filled out questionnaires by participants, the educational pamphlet will be distributed among participants in pamphlet group. The pamphlets will remain with the athletes. A month and a half after the first pamphlet, the same pamphlet 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 pamphlet, the application provides information for athletes in two parts: 1- preventive measurements on TDIs in sports including mouth guard usage and different types of this appliance, and 2- proper TDIs' management after occurrence including soft tissue damage, crown fracture, tooth luxation, tooth avulsion, and alveolar bone damage. 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 athletes via WhatsApp. Athletes 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 athletes 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>2020-05-09</approval_date>
        <contact_name>ٍEthics Committee of School of Dentistry- Tehran University of Medical Sciences</contact_name>
        <contact_address>School of Dentistry, Tehran University of Medical Sciences, North Kargar Street تهران Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
