<?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>IRCT201607049569N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-08-02</date_registration>
      <primary_sponsor>Vice Chancellor for Research of Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Effect of miniscrew design on survival rate and pain in orthodontic patients</public_title>
      <acronym></acronym>
      <scientific_title>A comparison of the effect of taper and cylindrical miniscrew designs on clinical success rate and pain in orthodontic patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-04-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>212</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/10148</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>3</phase>
      <hc_freetext>Orthodontic Anchorage Procedures.</hc_freetext>
      <i_freetext>Intervention 1: Control group: 106 cylindrical miniscrews manufactured by General Implant Company, with a diameter of 1.6mm and a length of 11mm will be inserted on both sides of maxilla between second premolar and first molar in 53 patients. During insertion of miniscrew, insertion torque will be measured by torque measurement device. miniscrews will be loaded immediately. Intervention 2: Intervention group: 106 taper miniscrews manufactured by General Implant Company, with a diameter of 1.6mm and a length of 11mm will be inserted on both sides of maxilla between second premolar and first molar in 53 patients. During insertion of miniscrew, insertion torque will be measured by torque measurement device. miniscrews will be loaded immediately.</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>Amir Mohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Orthodontics, Tabriz Dental Faculty, Tabriz University of Medical Sciences, Golgasht Street</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 41 3329 4312</telephone>
        <email>amirortho@gmail.com</email>
        <affiliation>Department of Orthodontics of Dental Faculty of Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Amir Mohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Orthodontics, Tabriz Dental Faculty, Tabriz University of Medical Sciences, Golgasht Street</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614713</zip>
        <telephone>+98 41 3329 4312</telephone>
        <email>amirortho@gmail.com</email>
        <affiliation>Department of Orthodontics of Dental Faculty of Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: A treatment plan to insert miniscrews on both sides of maxilla between the second premolar and the first molar for retraction of anterior teeth. Exclusion criteria: Any disease compromising bone quality like osteoporosis, osteomalasia, and osteopetrosis.</inclusion_criteria>
      <agemin>10 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z45.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Adjustment and management of other implanted devices</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: 106 cylindrical miniscrews manufactured by General Implant Company, with a diameter of 1.6mm and a length of 11mm will be inserted on both sides of maxilla between second premolar and first molar in 53 patients. During insertion of miniscrew, insertion torque will be measured by torque measurement device. miniscrews will be loaded immediately.</i_keyword>
      <i_keyword>Intervention group: 106 taper miniscrews manufactured by General Implant Company, with a diameter of 1.6mm and a length of 11mm will be inserted on both sides of maxilla between second premolar and first molar in 53 patients. During insertion of miniscrew, insertion torque will be measured by torque measurement device. miniscrews will be loaded immediately.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mobility in miniscrews. Timepoint: every 4 weeks after miniscrew placement. Method of measurement: By placing a calibrated probe on the miniscrew and lateral movement, if mobility is greater than 0.5 millimeter, the miniscrew is designated mobile.</prim_outcome>
      <prim_outcome>Pain. Timepoint: immediately after miniscrew placement and 6hours, 24hours, 48hours, and a week after. Method of measurement: registeration of the amount of pain from 0 (minimum pain) to 10 (maximum pain) according to Visual Analogue Scale in special times.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Amount of insertion torque of the miniscrews. Timepoint: during insertion of miniscrews. Method of measurement: Torque measurement device (Orthonia, JEIL Company).</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>Vice Chancellor for Research of Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-07-26</approval_date>
        <contact_name>Ethics Committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Ethics Committee of Tabriz University of Medical Sciences, Vice Chancellor for Research of Tabriz University of Medical Sciences,Tabriz University of Medical Sciences, Golgasht Street Tabriz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
