<?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>IRCT20200120046204N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-10-13</date_registration>
      <primary_sponsor>Tarbiat Modares University</primary_sponsor>
      <public_title>An educational intervention to promote behaviors related to oral and dental hygiene of adolescents</public_title>
      <acronym></acronym>
      <scientific_title>Title: The effect of educational intervention based on self-efficacy theory on promoting adolescent oral health behaviors through a mobile application</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-04-08</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65599</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: The random allocation of the samples will be done to maintain balance in the number of people assigned to the two control and test groups and to obtain the maximum power in the study by the method of repeated random blocks with blocks of 4. These repeating random blocks will be done for each floor separately. To implement this method, to maintain the randomness of the allocation of people, before starting the sampling, 6 combinations of four letters A (participant in the test group) and B (participant in the control group) are formed as follows:

	AABB
	ABAB
	ABBA
	BABA
	BBAA
	BAAB
Then, using six-sided dice with the numbers 1 to 6 on each side, according to the number that appears on the dice each time, the order of assigning the participants to the test and control groups in each class is as follows: It is determined independently.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Promotion of behaviors related to oral and dental hygiene.</hc_freetext>
      <i_freetext>Intervention 1: Intervention 1- The amount of oral hygiene in the intervention group(13-15-year-old female students) is first measured by a questionnaire. Then, this group receives mobile- based training during six sessions. Each session is 45 minutes of training. Each session is based on the theory of self-efficacy. The first session: Familiarization of students with mouth and teeth and diseases caused by non-observance of oral and dental hygiene. The second session: introducing students to the importance of oral and dental hygiene. The third session: introducing students to the importance of believing in their ability to observe oral and dental hygiene and preventing future dental problems. The fourth session: familiarizing the students with the importance of mastery experience, and observational experience in the prevention of oral and dental diseases. The fifth session: The role of verbal persuasion, physical and emotional state in the prevention of oral and dental diseases. The sixth session: Questions and answers. Intervention 2: Control group: The amount of oral hygiene information in this group is only measured by questionnaire and no training(intervention) in this group is presented.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seiedeh Zahra Marashi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Medical Sciences No.1., Nasr Bridge., Jalal Al Ahmad Highway.,Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14115-111</zip>
        <telephone>+98 61 3627 8656</telephone>
        <email>z.marashi@modares.ac.ir</email>
        <affiliation>The University of Tarbiat Modares</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Alireza Hidarnia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Medical Sciences No.1., Nasr Bridge., Jalal Al Ahmad Highway.,Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14115-111</zip>
        <telephone>+98 61 3627 8656</telephone>
        <email>hidarnia@modares.ac.ir</email>
        <affiliation>The University of Tarbiat Modares</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Female students aged 13-15 years
- A resident of Shushtar city
Do not have oral and dental disease
Don't have any underlying disease
They are studying
Having a smartphone and the ability to use it
Having informed consent to participate in the study
Participating in most educational intervention sessions</inclusion_criteria>
      <agemin>13 years</agemin>
      <agemax>15 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Female students should not be 13-15 years old
Do not live in Shushtar city.
Have oral and dental disease
Have a background knowledge
are not studying
Not having a smart phone and the skill to use it
Lack of informed consent to participate in the study
Failure to participate in most educational intervention sessions</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z00-Z13</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Persons encountering health services for examination and investigation</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention 1- The amount of oral hygiene in the intervention group(13-15-year-old female students) is first measured by a questionnaire. Then, this group receives mobile- based training during six sessions. Each session is 45 minutes of training. Each session is based on the theory of self-efficacy. The first session: Familiarization of students with mouth and teeth and diseases caused by non-observance of oral and dental hygiene. The second session: introducing students to the importance of oral and dental hygiene. The third session: introducing students to the importance of believing in their ability to observe oral and dental hygiene and preventing future dental problems. The fourth session: familiarizing the students with the importance of mastery experience, and observational experience in the prevention of oral and dental diseases. The fifth session: The role of verbal persuasion, physical and emotional state in the prevention of oral and dental diseases. The sixth session: Questions and answers.</i_keyword>
      <i_keyword>Control group: The amount of oral hygiene information in this group is only measured by questionnaire and no training(intervention) in this group is presented</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The average score of knowledge related to oral and dental hygiene. Timepoint: in three time periods before the intervention, one month, and three months after the intervention. Method of measurement: Standard questionnaire of awareness.</prim_outcome>
      <prim_outcome>The average score of attitude related to oral and dental hygiene. Timepoint: in three time periods before the intervention, one month, and three months after the intervention. Method of measurement: Standard questionnaire of attitude.</prim_outcome>
      <prim_outcome>The average score of self-efficacy related to oral and dental hygiene. Timepoint: in three time periods before the intervention, one month, and three months after the intervention. Method of measurement: Standard questionnaire of self-efficacy.</prim_outcome>
      <prim_outcome>The average score of performance related to oral and dental hygiene. Timepoint: in three time periods before the intervention, one month, and three months after the intervention. Method of measurement: Standard questionnaire of performance.</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>Tarbiat Modares University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-09-24</approval_date>
        <contact_name>Ethics Committee of Tarbiat Modares University of Medical Sciences</contact_name>
        <contact_address>Tarbiat modares univercity., Bridge Nasr., Jalal Al Ahmad.,Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
