<?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>IRCT20231025059848N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-12-14</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of braille pamphlet and Audio-tactile Performance Technique on the oral health of visually impaired adolescents</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of oral health promotion program among visually impaired adolescents of special schools of Mashhad using braille pamphlet and Audio-tactile Performance Technique</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-12-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/73509</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: Simple randomization with a table of random numbers at the cluster level.
A table of random numbers is prepared in the range [0, 1). According to the number of groups and participants in each group, a number is selected from the table of random numbers for each participant. The numbers are sorted from big to small; the first 30 numbers are in the first group, the second 30 numbers are in the second group, and the third 30 numbers are in the third group, Blinding description: Different individuals will do data collection and education of the participants. The person who collects data (either through a questionnaire or through oral examinations will be unaware of the groups. Also, the statistical consultant will not be aware of the groups when performing statistical evaluations.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Evaluating the level of knowledge, attitude, and information about how to deal with dental trauma in visually impaired adolescents..</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Oral health education will be received using a braille pamphlet at the beginning of the study and three months after the survey. Participants read Braille pamphlets in the presence of an attendant. Intervention 2: Intervention group 2:  Oral health education will be received by 3D models with a lecture (Audio-tactile Performance technique) at the beginning of the study and three months after the survey. Intervention 3: Control group: No oral health education will provide for this group.</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:
Part of the data related to the main outcome can be shared after de-identification.

When:
The access period starts from 1402

To whom:
These data will be accessible to researchers working in academic institutions.

Conditions:
If the data is used for cross-sectional studies.

Where to obtain:
Mahtab Mottaghi
mahmottaghi1999@gmail.com

How to obtain:
When composing an email, clearly outline the reasons why the data is necessary.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahtab Mottaghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 17, sixth Hejrat Ave., Sazemane ab Blvd., Mashhad Town</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9185875647</zip>
        <telephone>+98 51 3766 5718</telephone>
        <email>mahmottaghi1999@gmail.com</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahtab Mottaghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 17, sixth Hejrat Ave., Sazemane ab Blvd., Mashhad Town</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9185875647</zip>
        <telephone>+98 51 3766 5718</telephone>
        <email>mahmottaghi1999@gmail.com</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Congenital, totally visually impaired adolescent
bring the parental consent form
Age 10 to 19 years</inclusion_criteria>
      <agemin>10 years</agemin>
      <agemax>19 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Unwillingness to participate in the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Oral health education will be received using a braille pamphlet at the beginning of the study and three months after the survey. Participants read Braille pamphlets in the presence of an attendant.</i_keyword>
      <i_keyword>Intervention group 2:  Oral health education will be received by 3D models with a lecture (Audio-tactile Performance technique) at the beginning of the study and three months after the survey.</i_keyword>
      <i_keyword>Control group: No oral health education will provide for this group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The level of awareness of the participants in the form of knowledge score. Timepoint: before the intervention and six months after the intervention. Method of measurement: questionnaire.</prim_outcome>
      <prim_outcome>The level of awareness of the participants in the form of attitude score. Timepoint: before the intervention and six months after the intervention. Method of measurement: questionnaire.</prim_outcome>
      <prim_outcome>The level of awareness of the participants about how to deal with dental trauma. Timepoint: before the intervention and six months after the intervention. Method of measurement: questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Determination of DMFT (Decayed, Missing, Filled Teeth) index. Timepoint: before the intervention three, and six months after the intervention. Method of measurement: Clinical examination.</sec_outcome>
      <sec_outcome>Determination of OHI (Oral Hygiene Index). Timepoint: before the intervention three, and six months after the intervention. Method of measurement: Clinical examination.</sec_outcome>
      <sec_outcome>Determination of DI (Debris Index). Timepoint: before the intervention three, and six months after the intervention. Method of measurement: Clinical examination.</sec_outcome>
      <sec_outcome>Determination of BOP (Bleeding on Probing) index. Timepoint: before the intervention three, and six months after the intervention. Method of measurement: Clinical examination.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-01-18</approval_date>
        <contact_name>the Ethics Committee of the Faculty of Dentistry of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Mashhad, University Street, next to Hoizeh Cinema, Qorshi Building, Research and Technology Vice-Chancellor Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
