<?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>IRCT2017021431250N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-03-07</date_registration>
      <primary_sponsor>Vice chancellor for research, Islamic Azad University of Medical Science Dental School</primary_sponsor>
      <public_title>The Effect of the Titanium nitride coating on bacterial adhesion on orthodontic stainless steel wires</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of the Titanium nitride coating on bacterial adhesion on orthodontic stainless steel wires: invivo study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-01-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/24624</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Bacterial adhesion on TiN coated  orthodontic stainless steel wire.</hc_freetext>
      <i_freetext>Intervention 1: 19*25 Stainless steel  archwires will be evaluated, each patients will be their own control, the coated archwire will be assigned to one jaw randomly. After 4 weeks, the archwires will be removed and cut at similar lengths of 20 mm. they will be placed in sterile dishes containing saline phosphate buffer and sent to the lab for bacterial colony counting that includes dilution and culture on blood agar plates and eventually counting the colonies. each sample will be counted 3 times and the average number will be recorded. Intervention 2: The opposing jaw as a control group  will be recieve a non-coated 19*25 Stainless steel archwire.  After 4 weeks, the archwires will be removed and cut at similar lengths of 20 mm. they will be placed in sterile dishes containing saline phosphate buffer and sent to the lab for bacterial colony counting that includes dilution and culture on blood agar plates and eventually counting the colonies. each sample will be counted 3 times and the average number will be recorded.</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>Dr Fariborz Amini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 4 , 10th Neyestan, Pasdaran St, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 2256 4571</telephone>
        <email>F_amini@dentaliau.ac.ir</email>
        <affiliation>Islamic Azad University of Medical Science Dental School</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Fariborz Amini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 4 , 10th Neyestan, Pasdaran St, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 2256 4571</telephone>
        <email>F_amini@dentaliau.ac.ir</email>
        <affiliation>Islamic Azad University of Medical Science Dental School</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>inclusion criteria: patients which indication for placement of 19*25 Stainless steel archwires in both jaws&#13;
exclusion criteria: consumption of antibiotics and antibacterial mouthwashes</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>25 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>_</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>_</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>19*25 Stainless steel  archwires will be evaluated, each patients will be their own control, the coated archwire will be assigned to one jaw randomly. After 4 weeks, the archwires will be removed and cut at similar lengths of 20 mm. they will be placed in sterile dishes containing saline phosphate buffer and sent to the lab for bacterial colony counting that includes dilution and culture on blood agar plates and eventually counting the colonies. each sample will be counted 3 times and the average number will be recorded.</i_keyword>
      <i_keyword>The opposing jaw as a control group  will be recieve a non-coated 19*25 Stainless steel archwire.  After 4 weeks, the archwires will be removed and cut at similar lengths of 20 mm. they will be placed in sterile dishes containing saline phosphate buffer and sent to the lab for bacterial colony counting that includes dilution and culture on blood agar plates and eventually counting the colonies. each sample will be counted 3 times and the average number will be recorded.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Amount of Bacterial colonies. Timepoint: 4 weeks after placement wires. Method of measurement: Colony count.</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>Vice chancellor for research, Islamic Azad University of Medical Science Dental School</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-08-20</approval_date>
        <contact_name>Ethics commitee of Islamic Azad University of Medical Science Dental School</contact_name>
        <contact_address>No 4 , 10th Neyestan, Pasdaran St, Tehran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
