<?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>IRCT20201031049204N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-11-02</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Evaluating oral and dental hygiene education based on motivational interviewing in Orthodontic.</public_title>
      <acronym></acronym>
      <scientific_title>Evaluating an oral and dental hygiene education based on motivational interviewing in patients with fixed orthodontic appliances</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-07-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/51985</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Education/Guidance.</study_design>
      <phase>2</phase>
      <hc_freetext>patients undergoing fixed orthodontics.</hc_freetext>
      <i_freetext>Educational intervention is done in the form of counseling and motivational interview with the patient in the presence of his parents. First, the researcher states the purpose of the consultation and provides information about the causes of gingivitis, how dental plaque forms, and the effect of sugary and acidic foods on caries. Then we talk about the reasons that may affect dental hygiene behaviors. For example, the patient is asked not to delay the time of brushing so that fatigue does not prevent the control of plaque, or be sure to brush each time after the main meals. Apply fluoridated toothpaste, lasting at least two minutes at a time, and after brushing try to simply spit out the water and preferably not rinse the mouth with water. It is recommended that parents monitor their children's brushing. It also explains how oral health control affects the freshness of breathing and improves social relationships and acceptance of others. It is also noted that in the new conditions created by orthodontics in the mouth, the need for increased plaque control should be thoroughly cleaned. The patient is asked to comment and ask questions, positive behaviors are encouraged, identification problems and possible solutions are provided. Then the child is taught to brush and floss first on the model and then inside the mouth. During this stage, the patient follows the steps with the mirror he has, and in the next stage, the patient must repeat what he has learned in front of the mirror . A brochure containing information on how to brush and floss properly is also provided at the end. To motivate and be more effective, the patient is called once a week during the intervention, which is about a month..</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Still under investigation.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shima Ziari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 20, Ostad Nejatollahi St., Tehran Town</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1598984618</zip>
        <telephone>+98 21 8889 1058</telephone>
        <email>shimaziari@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahdia Gholami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>dental school of Tehran University of Medical Sciences, next to Atomic energy, North Krgar st</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1439955991</zip>
        <telephone>+98 21 8889 1058</telephone>
        <email>shimaziari@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients referred to the orthodontic department of the School of Dentistry of Tehran University of Medical Sciences who were in the age range of 12 to 16 years.
Patients participate in the study voluntarily.
signing Consent by parents</inclusion_criteria>
      <agemin>12 years</agemin>
      <agemax>16 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>They had a physical disability.
having systemic or underlying disease witch causing gingival or dental problems
taking certain medications</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>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Educational intervention is done in the form of counseling and motivational interview with the patient in the presence of his parents. First, the researcher states the purpose of the consultation and provides information about the causes of gingivitis, how dental plaque forms, and the effect of sugary and acidic foods on caries. Then we talk about the reasons that may affect dental hygiene behaviors. For example, the patient is asked not to delay the time of brushing so that fatigue does not prevent the control of plaque, or be sure to brush each time after the main meals. Apply fluoridated toothpaste, lasting at least two minutes at a time, and after brushing try to simply spit out the water and preferably not rinse the mouth with water. It is recommended that parents monitor their children's brushing. It also explains how oral health control affects the freshness of breathing and improves social relationships and acceptance of others. It is also noted that in the new conditions created by orthodontics in the mouth, the need for increased plaque control should be thoroughly cleaned. The patient is asked to comment and ask questions, positive behaviors are encouraged, identification problems and possible solutions are provided. Then the child is taught to brush and floss first on the model and then inside the mouth. During this stage, the patient follows the steps with the mirror he has, and in the next stage, the patient must repeat what he has learned in front of the mirror . A brochure containing information on how to brush and floss properly is also provided at the end. To motivate and be more effective, the patient is called once a week during the intervention, which is about a month.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Changing gingival index with a predetermined criterion of 0.5 unit. Timepoint: Registration of gingival index before and 1 month after the intervention. Method of measurement: Examination and registration of clinical index.</prim_outcome>
      <prim_outcome>Changing of plaque index with a predetermined criterion of 0.4 unit. Timepoint: Registration of plaque index before and 1 month after the intervention. Method of measurement: Examination and registration of clinical index.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Brushing time with a predetermined standard at least twice a day. Timepoint: record the number of brushing times before and 1 month after intervention. Method of measurement: oral health information checklist.</sec_outcome>
      <sec_outcome>Flossing with a predetermined standard at least twice a day. Timepoint: record the number of flossing before and 1 month after intervention. Method of measurement: oral health information checklist.</sec_outcome>
      <sec_outcome>Frequent consumption of sweet snacks with a predetermined standard up to twice a day. Timepoint: record the number of using sweet snacks before and 1 month after intervention. Method of measurement: oral health information checklist.</sec_outcome>
      <sec_outcome>Gingival inflammation status with a predetermined standard well/good. Timepoint: registration of gingival inflammation status before and 1 month after intervention. Method of measurement: examination and registration of condition.</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>2020-07-05</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Tehran University Dental School, after Atomic Energy,North Kargar St. Tehran Town Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
