<?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>IRCT20240119060731N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-02-12</date_registration>
      <primary_sponsor>Gorgan University of Medical Sciences</primary_sponsor>
      <public_title>The effectiveness of school orthodontic screening, specific referral letter and orthodontic advice on treatment rate in patients who need timely treatment</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of school orthodontic screening, specific referral letter and orthodontic advice on treatment rate in patients who need timely treatment: a cluster-randomized controlled trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-02-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>396</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/75180</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: Stratified randomization is done by gender, type of school and city
The unit of randomization is the school (cluster)
Allocation concealment will be achieved with sequentially numbered, opaque, sealed envelopes, Blinding description: Three last year dentistry students who perform orthodontic school screening are kept blind. intervention will be done after screening by independent person. 
Data analyst is kept blind to the allocation.</study_design>
      <phase>N/A</phase>
      <hc_freetext>timely treatment of patients in need of orthodontic treatment.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: screening in schools along with specific referral letter and orthodontic consultation. In this group of patients, orthodontic problems are diagnosed, and the referral letter (includes an explanation of the type of problem, the right time for treatment, and by whom they should be treated will be given to them ). Moreover, they are invited to visit the Faculty of Dentistry for orthodontic consultation. Intervention 2: Control group: Without screening, specific referral letter and orthodontic consultation. In this group of patients, orthodontic problems are diagnosed and no other intervention will be done for 6 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>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 more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Damavandi Kamali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 17, 2nd floor, Yademan building, Edalat Alley 21, Valiasr street</address>
        <city>Gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4917748855</zip>
        <telephone>+98 17 3232 7923</telephone>
        <email>dr.damavandi@goums.ac.ir</email>
        <affiliation>Gorgan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Damavandi Kamali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 17, 2nd floor, Yademan building, Edalat Alley 21, Valiasr street</address>
        <city>Gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4917748855</zip>
        <telephone>009832327923</telephone>
        <email>dr.damavandi@goums.ac.ir</email>
        <affiliation>Gorgan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All elementary schools in Gorgan, Aqqala, Kordkuy and Bandar-e-Gaz
Second grade students with reversed overjet, one or two anterior teeth crossbite, and/or posterior crossbite
Fifth grade students with increased overjet (more than 6mm), one or two anterior teeth crossbite, and/or posterior crossbite</inclusion_criteria>
      <agemin>7 years</agemin>
      <agemax>13 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Schools does not agree to participate in the study
Children who refuse to be examined
Parents refusal to give informed consent</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K07.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Anomalies of dental arch relationship</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Early detection</i_code>
      <i_code>Early detection</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: screening in schools along with specific referral letter and orthodontic consultation. In this group of patients, orthodontic problems are diagnosed, and the referral letter (includes an explanation of the type of problem, the right time for treatment, and by whom they should be treated will be given to them ). Moreover, they are invited to visit the Faculty of Dentistry for orthodontic consultation.</i_keyword>
      <i_keyword>Control group: Without screening, specific referral letter and orthodontic consultation. In this group of patients, orthodontic problems are diagnosed and no other intervention will be done for 6 month</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Attendance at orthodontist. Timepoint: 6 month after intervention. Method of measurement: parents complete a survey which inquired whether they took the child to the orthodontist.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Commencing orthodontic treatment. Timepoint: 6 months after intervention. Method of measurement: parents complete a survey which inquired whether orthodontic treatment has been commenced.</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>Gorgan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-09-26</approval_date>
        <contact_name>Ethics committee of Golestan University of Medical Sciences</contact_name>
        <contact_address>shahriar town Gorgan Golestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
