<?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>IRCT20170723035238N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-01-22</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of the clear expansion plate on the posterior teeth of the upper arch</public_title>
      <acronym></acronym>
      <scientific_title>The comparison of the effect of expansion with traditional and clear expansion plate on inclination of upper molars; a randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-01-25</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61047</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Numbered, sealed, opaque envelope (SNOSE); in this allocation system the researchers use mate envelopes. The number of the envelopes is equal with the number of the patients in each group. Then the envelops are gathered in the box. For each patients one envelope will be selected randomly and the group ( case or control ) will be selected in this way.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Upper arch constriction.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: clear expansion plate. In This group we will use clear expansion plate for the patients who need arch expansion . Clear expansion plate is made from thermoplastic sheets which is routinely used for the fabrication of clear retainers. An expansion screw is embedded in the midpalatal region of the thermoplastic sheet. The patients will activate the screw twice a week . Each activation make separation between two halves of the appliance and expansion of the arch laterally. this expansion may change the buccolingual inclination of the posterior teeth. the buccolingual inclination of the upper first molar will be measured and compared before and after treatment. The inter-group comparison will be dene as well. Intervention 2: Intervention group: traditional expansion plate.In This group we will use traditional acrylic expansion plate for the patients who need arch expansion . acrylic expansion plate is made from the wire elements and acrylic framework. An expansion screw is embedded in the midpalatal region of the acrylic framework . The patients will activate the screw twice a week . Each activation make separation between two halves of the appliance and expansion of the arch laterally. this expansion may change the buccolingual inclination of the posterior teeth. the buccolingual inclination of the upper first molar will be  The inter-group comparison will be dene as well.measured and compared before and after treatment.</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 no decision has been made regarding to data release</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ahmad Behroozian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tabriz University of Medical Sciences / Golgasht st. / Azadi st.</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614711</zip>
        <telephone>+98 41 3334 7635</telephone>
        <email>ahmadbehroozian@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ahmad Behroozian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tabriz University of Medical Sciences / Golgasht st. / Azadi st.</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614711</zip>
        <telephone>+98 41 3334 7635</telephone>
        <email>ahmadbehrouzian@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Mixed dentition patients
The patients' tendency to attend in the study
Signing the informed consent form to participate in the study
Upper arch constriction</inclusion_criteria>
      <agemin>5 years</agemin>
      <agemax>14 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Poor patient cooperation in follow-up sessions
Poor oral hygiene
Extraction of upper first molars during  the treatment
Fracture, crown or any kind of restoration which involve the occlusal surface of the first  molars</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M26.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malocclusion, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: clear expansion plate. In This group we will use clear expansion plate for the patients who need arch expansion . Clear expansion plate is made from thermoplastic sheets which is routinely used for the fabrication of clear retainers. An expansion screw is embedded in the midpalatal region of the thermoplastic sheet. The patients will activate the screw twice a week . Each activation make separation between two halves of the appliance and expansion of the arch laterally. this expansion may change the buccolingual inclination of the posterior teeth. the buccolingual inclination of the upper first molar will be measured and compared before and after treatment. The inter-group comparison will be dene as well.</i_keyword>
      <i_keyword>Intervention group: traditional expansion plate.In This group we will use traditional acrylic expansion plate for the patients who need arch expansion . acrylic expansion plate is made from the wire elements and acrylic framework. An expansion screw is embedded in the midpalatal region of the acrylic framework . The patients will activate the screw twice a week . Each activation make separation between two halves of the appliance and expansion of the arch laterally. this expansion may change the buccolingual inclination of the posterior teeth. the buccolingual inclination of the upper first molar will be  The inter-group comparison will be dene as well.measured and compared before and after treatment.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The change in the toque of upper posterior teeth. Timepoint: Before treatment and 6 months later. Method of measurement: Stone casts.</prim_outcome>
      <prim_outcome>Arch expansion. Timepoint: Before treatment and 6 months later. Method of measurement: Stone casts.</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-01-03</approval_date>
        <contact_name>Ethics committee of  Tabriz University of Medical Sciences</contact_name>
        <contact_address>Central building of Tabriz medical university / Golgasht st. / Azadi st. Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
