<?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>IRCT2017101036705N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-11-09</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences</primary_sponsor>
      <public_title>Treatment effects of Twin Block appliance in different cervical vertebral maturation stages amongst patients with mandibular retrognathism</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the treatmaent effects of  the  Twin Block appliance in different cervical vertebral maturation stages amognst patients with mandibular retrognathism  referring to an orthodontics office in Kerman, 2017</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>46</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/27365</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Mandibular retrognathism.</hc_freetext>
      <i_freetext>Intervention name: Twin Block functional appliance&#13;
         Intervention Description:&#13;
 This appliance is employed in order to treat mandibular retrognathism. The patient should have full cooperation in using the device and wear the device at least 16 hours a day. The device will be used as long as the patient's overjet is zero, and the treatment effects of intervention is investigated by lateral cephalographs of the patients before and after the treatment. This study does not have a control 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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Parisa Kalantari Khandani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Next to Shafa hospital, End of Shafa St, Jomhouri Blvd, Kerman, Iran</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 342454554</telephone>
        <email>kalantary_parisa@yahoo.comkalantari.parisa1988@gmail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Parisa Kalantari Khandani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Next to Shafa hospital, End of Shafa St, Jomhouri Blvd, Kerman, Iran</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 342454554</telephone>
        <email>kalantary_parisa@yahoo.com kalantari.parisa1988@gmail.com kalantary.mahsa@yahoo.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Subjects with bilateral molar and canine class II relationship; Skeletal class II relationship measured on cephalometric radiograph (ANB &gt; 3.5); Mandibular retrognathism measured on cephalometric radiograph (SNB&lt;78); Patients with normal or decreased U1-SN angle; Patients of growing age (9-16 years) who were in CS-2, CS-3 and CS-4 of cervical vertebral maturation stage, according to Baccetti et al  Excusion criteria: Patients with any craniofacial anomaly or syndrome;  Noncompliant patients who failed to wear the appliance for more than 16hours/day ; Subjects with history of orthodontic treatment.</inclusion_criteria>
      <agemin>9 years</agemin>
      <agemax>16 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K07.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Anomalies of jaw-cranial base relationship</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention name: Twin Block functional appliance&#13;
         Intervention Description:&#13;
 This appliance is employed in order to treat mandibular retrognathism. The patient should have full cooperation in using the device and wear the device at least 16 hours a day. The device will be used as long as the patient's overjet is zero, and the treatment effects of intervention is investigated by lateral cephalographs of the patients before and after the treatment. This study does not have a control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mandibular Ramus Lenght. Timepoint: Pre intervention and Post intervention. Method of measurement: Evaluation of lateral cephalometry.</prim_outcome>
      <prim_outcome>SNA angle. Timepoint: Pre intervention and Post intervention. Method of measurement: Evaluation of lateral cephalometry.</prim_outcome>
      <prim_outcome>SNB angle. Timepoint: Pre intervention and Post intervention. Method of measurement: Evaluation of lateral cephalometry.</prim_outcome>
      <prim_outcome>ANB angle. Timepoint: Pre intervention and Post intervention. Method of measurement: Evaluation of lateral cephalometry.</prim_outcome>
      <prim_outcome>GoGn-SN angle. Timepoint: Pre intervention and Post intervention. Method of measurement: Evaluation of lateral cephalometry.</prim_outcome>
      <prim_outcome>Co-A distance. Timepoint: Pre intervention and Post intervention. Method of measurement: Evaluation of lateral cephalometry.</prim_outcome>
      <prim_outcome>Co-Gn distance. Timepoint: Pre intervention and Post intervention. Method of measurement: Evaluation of lateral cephalometry.</prim_outcome>
      <prim_outcome>Go-Gn distance. Timepoint: Pre intervention and Post intervention. Method of measurement: Evaluation of lateral cephalometry.</prim_outcome>
      <prim_outcome>U1-SN angle. Timepoint: Pre intervention and Post intervention. Method of measurement: Evaluation of lateral cephalometry.</prim_outcome>
      <prim_outcome>IMPA angle. Timepoint: Pre intervention and Post intervention. Method of measurement: Evaluation of lateral cephalometry.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>SNA angle. Timepoint: Pre and Post treatment. Method of measurement: Evaluation of lateral cephalometry.</sec_outcome>
      <sec_outcome>SNB angle. Timepoint: Pre and Post treatment. Method of measurement: Evaluation of lateral cephalometry.</sec_outcome>
      <sec_outcome>ANB angle. Timepoint: Pre and Post treatment. Method of measurement: Evaluation of lateral cephalometry.</sec_outcome>
      <sec_outcome>Go-Gn angle. Timepoint: Pre and Post treatment. Method of measurement: Evaluation of lateral cephalometry.</sec_outcome>
      <sec_outcome>Co-A distance. Timepoint: Pre and Post treatment. Method of measurement: Evaluation of lateral cephalometry.</sec_outcome>
      <sec_outcome>Co-Gn distance. Timepoint: Pre and Post treatment. Method of measurement: Evaluation of lateral cephalometry.</sec_outcome>
      <sec_outcome>Ramus lenght. Timepoint: Pre and Post treatment. Method of measurement: Evaluation of lateral cephalometry.</sec_outcome>
      <sec_outcome>Go-Gn distance. Timepoint: Pre and Post treatment. Method of measurement: Evaluation of lateral cephalometry.</sec_outcome>
      <sec_outcome>U1-SN angle. Timepoint: Pre and Post treatment. Method of measurement: Evaluation of lateral cephalometry.</sec_outcome>
      <sec_outcome>IMPA angle. Timepoint: Pre and Post treatment. Method of measurement: Evaluation of lateral cephalometry.</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>Kerman University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-10-31</approval_date>
        <contact_name>Kerman University of Medical Sciences</contact_name>
        <contact_address>Next to Shafa hospital, End of Shafa St, Jomhouri Blvd, Kerman, Iran Kerman  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
