<?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>IRCT20180102038190N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-03-12</date_registration>
      <primary_sponsor>Babol University of Medical Sciences</primary_sponsor>
      <public_title>Effect of fluoride on orthodontic wire</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation the effect of different methods of fluoride agents prescription on the Surface roughness of Rhodium coated NiTi orthodontic wires</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-03-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>15</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/37741</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Diagnostic, Blinding description: the data analyst does not know the type of substance received by the groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Effect of fluoride on orthodontic wires.</hc_freetext>
      <i_freetext>Intervention 1: Control group: Use of fluoride toothpaste (Oral-B 315 ppm) twice daily. Intervention 2: Intervention group: Use Oral-B fluoride toothpaste twice a day with 0.05% fluoride and use daily mouthwash (Oral-B 226 ppm)once a day (15 ml) after brushing for 30 seconds. eating and drinking for 30 minutes after use is prohibited. Intervention 3: Intervention group: Use Oral-B fluoride toothpaste twice a day with 0.05% fluoride and use fluoride gel (Sultan1.23% Fluoride ion, pH = 3.5): The gel is placed in the mouth of the patient once for 60 seconds, according to the manufacturer's recommendation. eating and drinking for 30 minutes after use is prohibited.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Meisam Mirzaie</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Entefazeh Squre., Babol School of Dentistry</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>47176-43633</zip>
        <telephone>+98 11 3219 9592</telephone>
        <email>s.sheikhzadeh@mubabol.ac.ir</email>
        <affiliation>Babol University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Meisam Mirzaie</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Entefazeh Squre., Babol School of Dentistry</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>47176-43633</zip>
        <telephone>+98 11 3219 9592</telephone>
        <email>s.sheikhzadeh@mubabol.ac.ir</email>
        <affiliation>Babol University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients who are able to afford adequate health care
Patients who have all of the maxillary teeth
Patients between 15-25 years old</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>25 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients who are not able to afford adequate health care
Patients using certain mouthwashes
Patients who have a specific disease affecting the flow of saliva (such as ُSjogren's syndrome, etc.)
Patients who use a drug that has an effect on the flow of saliva
smokers and alcohol drinkers
patients who have dental openbite
patients who are longface.
patients who have high acid intake in their diet.
patients who have excessive crowding on the straight part of wire</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>Diagnosis</i_code>
      <i_code>Diagnosis</i_code>
      <i_code>Diagnosis</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: Use of fluoride toothpaste (Oral-B 315 ppm) twice daily</i_keyword>
      <i_keyword>Intervention group: Use Oral-B fluoride toothpaste twice a day with 0.05% fluoride and use daily mouthwash (Oral-B 226 ppm)once a day (15 ml) after brushing for 30 seconds. eating and drinking for 30 minutes after use is prohibited.</i_keyword>
      <i_keyword>Intervention group: Use Oral-B fluoride toothpaste twice a day with 0.05% fluoride and use fluoride gel (Sultan1.23% Fluoride ion, pH = 3.5): The gel is placed in the mouth of the patient once for 60 seconds, according to the manufacturer's recommendation. eating and drinking for 30 minutes after use is prohibited.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Measured values on "Atomic force microscopy". Timepoint: Evaluating wires by Atomic force microscopy at the beginning of the study (before intervention) and 6 weeks after placement in the mouth. Method of measurement: Evaluating surface by Atomic force microscopy.</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>Babol University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-02-05</approval_date>
        <contact_name>Ethics committee of Babol University of Medical Sciences</contact_name>
        <contact_address>Ganjafrooz Ave., Babol University of Medical Sciences Babol Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
