<?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>IRCT20180214038729N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-03-21</date_registration>
      <primary_sponsor>Damascus University/ Faculty of Dentistry</primary_sponsor>
      <public_title>E-Learning for improving oral health of children.</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of a health education program based on E-Learning versus leaflets in promoting oral hygiene practice of school children.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-01-24</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>220</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/29662</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Simple randomization using coin-tossing. 
The unit of randomization was the school. 
Allocation is not concealed.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Dental caries. Condition 2: Oral hygiene. Condition 3: Gingivitis. Condition 4: Level of oral health knowledge.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Leaflet group: A colorful and attractive leaflet in the form of a short story named “Adnan likes the dentist” was designed by a graphic designer. The leaflets were designed with particular emphasis on creating interest amongst the children. These educational papers included information related to proper brushing technique and frequency; introduced the regular use of dental floss; emphasized regular dental visits as well as provided basic demonstration of dental plaque and the implications of not removing it. The leaflets also contained nutritional guidelines in regards to minimizing caries risk, and finally the role of fluoride in caries control. Intervention 2: Intervention group 2: E-learning group: An E-learning program was designed by an expert in artificial intelligence. The program was full of colorful images, videos, interactive quizzes and age-related developmental tasks in the quest to deliver the information in an interactive, entertaining and simple manner. The E-learning program included the same information of the leaflet; only the way in which the content is conveyed to the children was different.</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:
Study Protocol, Statistical Analysis, Clinical Study Report, Leaflets used in the study, Oral Health Questionnaire

When:
Immediately following publication. Ending 5 years following publication

To whom:
Researchers who provide a methodologically sound proposal

Conditions:
Data could be used for academic research only, and could not be available for third party without agreement of the authors.
Also, available data will be written in Arabic language and its use should be either in Arabic or in an English translation after verifying the translation with the author, exception of the Leaflets and Oral Health Questionnaire because there is an English versions.

Where to obtain:
Directly from the author at susan.bardaweel@hotmail.co.uk

How to obtain:
The author will respond to the applicant within one week of receiving his/her request by e-mail, but final data providing will be within three months.

Comments:
We do not have postal code in Syria.
I do not have professional email address</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Susan Bardaweel</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Antara Alabsi street, East Tejara, Ninth floor, Apartment 2, Damascus, Syria</address>
        <city>Damascus</city>
        <country1>Syrian Arab Republic</country1>
        <zip>Not applicable</zip>
        <telephone>+963 11 446 5707</telephone>
        <email>susan.bardaweel@hotmail.co.uk</email>
        <affiliation>Damascus University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Susan Bardaweel</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Antara Alabsi street, East Tejara, Ninth floor, Apartment 2, Damascus, Syria</address>
        <city>Damascus</city>
        <country1>Syrian Arab Republic</country1>
        <zip>Not applicable</zip>
        <telephone>+963 11 446 5707</telephone>
        <email>susan.bardaweel@hotmail.co.uk</email>
        <affiliation>Damascus University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Syrian Arab Republic</country2>
      <country2>Syrian Arab Republic</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All healthy children who accepted to take part in this study
Children who did not receive any previous dental educational program
Children who had internet access connection and ability to browse and use the internet</inclusion_criteria>
      <agemin>10 years</agemin>
      <agemax>11 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>children outside the age range of the study
children currently under the regular care of an oral health care provider
children who have access to oral health education through a different and separate source than our intervention
children with acute dental issues (e.g.: dental abscess)
mentally or physically compromised children
children whose parents did not provide consent for participation in our study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K02</hc_code>
      <hc_code></hc_code>
      <hc_code>K05</hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Dental caries</hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword>Gingivitis and periodontal diseases</hc_keyword>
      <hc_keyword></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: Leaflet group: A colorful and attractive leaflet in the form of a short story named “Adnan likes the dentist” was designed by a graphic designer. The leaflets were designed with particular emphasis on creating interest amongst the children. These educational papers included information related to proper brushing technique and frequency; introduced the regular use of dental floss; emphasized regular dental visits as well as provided basic demonstration of dental plaque and the implications of not removing it. The leaflets also contained nutritional guidelines in regards to minimizing caries risk, and finally the role of fluoride in caries control.</i_keyword>
      <i_keyword>Intervention group 2: E-learning group: An E-learning program was designed by an expert in artificial intelligence. The program was full of colorful images, videos, interactive quizzes and age-related developmental tasks in the quest to deliver the information in an interactive, entertaining and simple manner. The E-learning program included the same information of the leaflet; only the way in which the content is conveyed to the children was different.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Change in oral health knowledge level. Timepoint: Oral health knowledge level was assessed at baseline, 6 and at 12 weeks of oral health education. Method of measurement: Oral health knowledge level was assessed using a questionnaire designed specifically for the study.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Change in plaque accumulation. Timepoint: Dental Plaque was assessed at baseline, 6 and at 12 weeks of oral health education. Method of measurement: Plaque accumulation was assessed using Plaque Index (PI) for Silness and Löe.</sec_outcome>
      <sec_outcome>Change in gingival health. Timepoint: Gingival health was assessed at baseline, 6 and at 12 weeks of oral health education. Method of measurement: Gingival health was assessed using Gingival Index (GI) for Löe and Silness.</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>Damascus University/ Faculty of Dentistry</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-01-11</approval_date>
        <contact_name>Ethics committee of Ministry of Education</contact_name>
        <contact_address>Al-Mazraa, Al-Shahbandar Square, Ministry of Education, Damascus, Syria Damascus Damascus Syrian Arab Republic</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
