<?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>IRCT2014032117067N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-09-03</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation the effect of two mouthwashes on surface characterization of orthodontic wire and bracket and friction between bracket and wire</public_title>
      <acronym>-</acronym>
      <scientific_title>A clinical trial for comparison the effect of two mouthwashes, Persica and Chlorhexidine, on surface characterization and static friction between wire and bracket in orthodontic patients.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-12-31</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/15806</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: In order to randomized assignment of samples, three folded paper cards were used.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Surface characterizations of orthodontic wire and bracket and static friction between wire and bracket in dry state.</hc_freetext>
      <i_freetext>Intervention 1: Intervention name: Chlorhexidine gluconate 0.2%&#13;
 &#13;
Administration: The mouth is rinsed with 30 ml (2 Tablespoons) of undiluted chlorhexidine twice daily (morning and night) for 30 seconds after brushing for two weeks.&#13;
&#13;
Individuals must expectorate the chlorhexidine after rinsing and must not rinse their mouths with water or mouthwashes, brush their teeth, or eat immediately after using chlorhexidine.&#13;
&#13;
Patients should clean their teeth with Oral-B tooth brush and  Crest, Gum Protection tooth paste. Intervention 2: Intervention name: Persica&#13;
Administration: The mouth is rinsed with 30 ml (2 Tablespoons) of diluted Persica (15 mlit Persica and 15 mlit water),  twice daily (morning and night) for 30 seconds after brushing for two weeks. Patients should clean their teeth with Oral-B tooth brush and Crest, Gum Protection tooth paste. Intervention 3: Control: Active control&#13;
 Patients should clean their teeth with Oral-B tooth brush and Crest, Gum Protection tooth paste.</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>Elham sadat Emadian Razavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>North Kargar st., Department of Orthodontics, Faculty of Dentistry, Tehran University of Medical Sciences</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8897 7921</telephone>
        <email>e-emadian@razi.tums.ac.ir</email>
        <affiliation>Department of Orthodontics, Faculty of Dentistry, Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Tahereh Hosseinzadeh Nik</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>North Kargar st., Department of Orthodontics, Faculty of Dentistry, Tehran University of Medical Sciences</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>-</zip>
        <telephone>+98 21 8897 7921</telephone>
        <email>hoseinit@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:&#13;
Ability to control oral hygiene.&#13;
Exclusion criteria:&#13;
Metabolic and systemic diseases;&#13;
Salivary gland diseases;&#13;
Consuming medications that affect amount or consistency of saliva;&#13;
Consuming any other mouthrinse;&#13;
Cigarette smoking;&#13;
Drug  abusing;&#13;
Pregnancy or breast feeding</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T78.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other adverse effects, not elsewhere classified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention name: Chlorhexidine gluconate 0.2%&#13;
 &#13;
Administration: The mouth is rinsed with 30 ml (2 Tablespoons) of undiluted chlorhexidine twice daily (morning and night) for 30 seconds after brushing for two weeks.&#13;
&#13;
Individuals must expectorate the chlorhexidine after rinsing and must not rinse their mouths with water or mouthwashes, brush their teeth, or eat immediately after using chlorhexidine.&#13;
&#13;
Patients should clean their teeth with Oral-B tooth brush and  Crest, Gum Protection tooth paste.</i_keyword>
      <i_keyword>Intervention name: Persica&#13;
Administration: The mouth is rinsed with 30 ml (2 Tablespoons) of diluted Persica (15 mlit Persica and 15 mlit water),  twice daily (morning and night) for 30 seconds after brushing for two weeks. Patients should clean their teeth with Oral-B tooth brush and Crest, Gum Protection tooth paste.</i_keyword>
      <i_keyword>Control: Active control&#13;
 Patients should clean their teeth with Oral-B tooth brush and Crest, Gum Protection tooth paste.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Surface characterization of orthodontic wire. Timepoint: Two weeks. Method of measurement: Atomic Force Microsccope.</prim_outcome>
      <prim_outcome>Surface charachterization of brackets. Timepoint: Two weeks. Method of measurement: Scanning Electron Microscope.</prim_outcome>
      <prim_outcome>Static friction between orthodontic wire and bracket. Timepoint: Two weeks. Method of measurement: Universal Testing Machine.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-05-05</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Enqelab Square, Tehran University of Medical Sciences Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
