<?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>IRCT20140215016582N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-07-03</date_registration>
      <primary_sponsor>Vice Chancellor for Research and Technology, Hamedan University of Medical Science</primary_sponsor>
      <public_title>Effect of titanuim oxide coating on streptococcus mutans adhesion</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of streptococcus mutans adhesion on stainless steel orthodontic wire caoted with titanuim oxide in orthodontic patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-08-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>68</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/37098</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study, a block randomization method is used. Group name (A, B, C, D)  is written on the 4 cards and the first patient chooses one of them. The next patient chooses one of the three remaining cards, the next patient will be assigned one of the two cards and the last card allocated to the fourth patient, Blinding description: Participants are unaware of wires(coated or non-coated) located in the upper or lower jaw, and also, the person who evaluates the outcome is  blinded.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Streptococcus mutans adhesion to orthodontic wire.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group : In Group A, the orthodontic wires 0.018 stainless steel coated with 100 nm titanium oxide layer are randomly located in the upper or lower jaw and after one week exit from mouth. Intervention 2: Intervention group:  In Group B, the orthodontic wires 0.018 stainless steel coated with 100 nm titanium oxide layer are randomly located in the upper or lower jaw and after two weeks exit from mouth. Intervention 3: Intervention group: In group C,  the orthodontic wires 0.018 stainless steel coated with 100 nm titanium oxide layer are randomly placed in the upper or lower jaw and exit after three weeks from mouth. Intervention 4: Intervention group:  In Group D, the orthodontic wires 0.018 stainless steel coated with 100 nm titanium oxide layer are randomly placed in the upper or lower jaw and exit after four weeks from mouth. Intervention 5: Control group: The control group is uncoated orthodontic wires 0.018 stainless steel that is placed in the opposite jaw in front of the intervention 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Individual data including demographic characteristics and original outcome information are shared.

When:
Start the access period 6 months after printing the results

To whom:
Researchers working in academic and scientific institutes and dental material industry

Conditions:
Unidentifiable information will not be provided due to the type of consent given to patients and the obligation of the investigator to comply with ethical requirements.

Where to obtain:
Ziba Banisafar, Corresponding author, zbanisafar@yahoo.com
Vahid Mollabashi, First authorو mollabashi@umsha.ac.ir

How to obtain:
After 6 month of result publication through electronic E-Mail of corresponding author and complete introduction and mention the goal from having the documentation, related file is available to the applicant.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ziba Banisafar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Fahmideh Ave.,Hamadan University of Medical Science</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>65178-38677</zip>
        <telephone>+98 81 3838 1059</telephone>
        <email>zbanisafar@yahoo.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ziba Banisafar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Fahmideh Ave., Hamadan University of Medical Science</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>65178-38677</zip>
        <telephone>+98 81 3838 1059</telephone>
        <email>zbanisafar@yahoo.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients referring to Hamadan Dental School
Age ranged 12-25 years old
Non-use of  antibacterial mouthwashes and antibiotics during treatment
Non-use of interarch elastics,chain,O-ring and open coil during treatment</inclusion_criteria>
      <agemin>12 years</agemin>
      <agemax>25 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The presence of systemic diseases such as : diabetes, AIDS and consumers of immunosuppressive drugs
Pregnancy
Smoking
The presence of dental missing, syndroms and craniofacial anomalies</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>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group : In Group A, the orthodontic wires 0.018 stainless steel coated with 100 nm titanium oxide layer are randomly located in the upper or lower jaw and after one week exit from mouth.</i_keyword>
      <i_keyword>Intervention group:  In Group B, the orthodontic wires 0.018 stainless steel coated with 100 nm titanium oxide layer are randomly located in the upper or lower jaw and after two weeks exit from mouth.</i_keyword>
      <i_keyword>Intervention group: In group C,  the orthodontic wires 0.018 stainless steel coated with 100 nm titanium oxide layer are randomly placed in the upper or lower jaw and exit after three weeks from mouth.</i_keyword>
      <i_keyword>Intervention group:  In Group D, the orthodontic wires 0.018 stainless steel coated with 100 nm titanium oxide layer are randomly placed in the upper or lower jaw and exit after four weeks from mouth.</i_keyword>
      <i_keyword>Control group: The control group is uncoated orthodontic wires 0.018 stainless steel that is placed in the opposite jaw in front of the intervention group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Streptococcus mutans adhesion to orthodontic wires. Timepoint: Bacterial counting in 4 groups with 1 to 4 weeks interval. Method of measurement: Colony count.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Evaluation of anti-adherent property of coated wire during the time. Timepoint: Aftar 1 week , 2 weeks, 3 weeks, 4 weeks. Method of measurement: Colony count.</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 and Technology, Hamedan University of Medical Science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-01-26</approval_date>
        <contact_name>Ethics committee of Hamadan University of Medical Sciences</contact_name>
        <contact_address>Shahid Fahmide Ave., Hamadan university of Medical science Hamadan Hamadan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
