<?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>IRCT201204289569N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-06-27</date_registration>
      <primary_sponsor>Vice Chancellor for Research of Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>The Influence of Surface Roughening of Orthodontic Miniscrews on Their Clinical Success Rate</public_title>
      <acronym></acronym>
      <scientific_title>The Comparison of Clinical Success Rates of Surface Roughened Orthodontic Miniscrews with Conventional One</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-05-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/10146</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: The operator inserting the miniscrews has two miniscrew boxes. Box “A” and box “B”. Only miniscrews in box “A” have been roughened. He knows that the miniscrews of one of the boxes have been roughened, but he does not know which one of the boxes has the roughened miniscrews. He just inserts the miniscrews of box “A” on the right side and the miniscrews of box “B” on the left side in the odd number patients (according to referral). Conversely, in the even number patients, he places the miniscrews of box “B” on the right side and the miniscrews of box “A” on the left side.&#13;
All the patients know that the miniscrew on one of the sides is roughened, but they do not know which one of them is roughened.&#13;
Therefore, the patients and the operator who inserts the miniscrews do not know which one of the inserted miniscrews is roughened; This study as aresult is a double-blind clinical trial.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Orthodontic Anchorage Procedures.</hc_freetext>
      <i_freetext>Sixty miniscrews manufactured by Jeil Company, with a diameter of 1.6mm and a length of 10mm will be randomly divided into case and control groups. The case group samples will be roughened by sandblasting and acid etching. Surface roughening will be carried out as follows: First of all, the miniscrews will be polished and sandblasted with aluminum oxide particles under the pressure of 4MPa. Then irrigation will be carried out with acetone, 75% alcohol ethylic, and distilled water in an ultrasonic cleanser for 15 minutes, in turn. Subsequently the samples will be put in a solution of hydrofluoric acid with a concentration 0.11 mol per liter and nitric acid with a concentration of 0.09mol per liter at room temperature for 10 minutes. Then the samples will be maintained in an oven at 50°C for 24 hours. Subsequently the samples will be put into a solution of hydrochloric acid with a concentration of 5.8mol per liter and sulfuric acid with a concentration of 8.96mol per liter at 80°C for 30 minutes. Finally, an oven at 50°C will be used for drying the miniscrews for 24 hours..</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 St</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614713</zip>
        <telephone>+98 411335596</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 St</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166614713</zip>
        <telephone>+98 41 1329 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.&#13;
Exclusion criteria: Any disease compromising bone quality like osteoporosis, osteopetrosis, osteomalasia.</inclusion_criteria>
      <agemin>10 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T84.9, Z45</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Unspecified complication of internal orthopaedic prosthetic device, implant and graft; Adjustment and management of other implant devices</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Sixty miniscrews manufactured by Jeil Company, with a diameter of 1.6mm and a length of 10mm will be randomly divided into case and control groups. The case group samples will be roughened by sandblasting and acid etching. Surface roughening will be carried out as follows: First of all, the miniscrews will be polished and sandblasted with aluminum oxide particles under the pressure of 4MPa. Then irrigation will be carried out with acetone, 75% alcohol ethylic, and distilled water in an ultrasonic cleanser for 15 minutes, in turn. Subsequently the samples will be put in a solution of hydrofluoric acid with a concentration 0.11 mol per liter and nitric acid with a concentration of 0.09mol per liter at room temperature for 10 minutes. Then the samples will be maintained in an oven at 50°C for 24 hours. Subsequently the samples will be put into a solution of hydrochloric acid with a concentration of 5.8mol per liter and sulfuric acid with a concentration of 8.96mol per liter at 80°C for 30 minutes. Finally, an oven at 50°C will be used for drying the miniscrews for 24 hours.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Detection of mobility in the miniscrews. Timepoint: Six weeks and six months after insertion of the miniscrew. Method of measurement: Check list to record the mobility.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Amount of removal torque of the miniscrews. Timepoint: Six months after insertion of miniscrews. Method of measurement: Torque measurment 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>2012-04-05</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 Tabriz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
