<?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>IRCT20180923041092N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-11-23</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>effect of Thymus Vulgaris essential oil on Candida albicans</public_title>
      <acronym></acronym>
      <scientific_title>Clinical comparison of the effect of Thymus Vulgaris essential oil and Chlorhexidine on Candida albicans accumulated on orthodontic removable plaques</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-04-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/34180</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Blinding description: Participants and all researchers except that person who determines code to the solutions are blind in this study.
Only one researcher who determines color code to the solutions,  does not play a role in collecting data is not blind in this study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>In the present study, to find the desired sample size, a number of patients with removable orthodontic plaque in a private clinic were randomly selected. Before starting the study, an interview was conducted with them to evaluate their dental and medical history, oral health status, occlusion and proper dental care and their health status. Of the 43 patients who were sampled, those who had one of the following were excluded from the study, and 36 who were eligible for inclusion in the study were selected for further studies: - No Candida albicans on Orthodontic removable plaque-Large diastema-Periodontal problem-Use Antimicrobial mouthwash-Antibiotic use in the last 3 months-Very poor oral hygiene.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Participants in intervention group obtained a solution containing thymus vulgaris 2%. They were asked to spray solutions on to an orthodontic removable appliance.Swab from three specific of removable orthodontic appliance were taken three times: 1.At the beginning of study. 2. After two days. 3. After 5 five days. Intervention 2: Control group: Participants in control group obtained a solution containing Chlorhexidine 0/2%. They were asked to spray solutions on to an orthodontic removable appliance. Swab from three specific of removable orthodontic appliance were taken three times:1. At the beginning of study2. After two days3. After 5 five days.</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:
Classification of individuals based on the number of Candida albicans grown colonies in three sampling times (Before spraying 2% Thymus Vulgaris essential oil and Chlorhexidine 0.2%, two days and then five days after spraying)

When:
Start of access period 6 months after printing results

To whom:
Every one

Conditions:
No one is allowed to work on our data

Where to obtain:
send Email to T-baheri@yahoo.com and announce the request.

How to obtain:
send Email to T-baheri@yahoo.com and announce the request.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Tahereh Baheri Moghadam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>3th Floor, medical Bldg, 11 Alley, Sattar Khan Ave.</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71847-35716</zip>
        <telephone>+98 71 3649 1415</telephone>
        <email>T_baheri@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Navid Naseri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>3th floor, medical Bldg, 11 Alley, Sattar Khan Ave.</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71847-35716</zip>
        <telephone>+98 71 3649 1415</telephone>
        <email>T_baheri@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>patients with expansion orthodontic appliance</inclusion_criteria>
      <agemin>7 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Moderate to Severe Crowding and Irregularity
Periodontal Problem
Usage of Antimicrobial Mouth Watch
Antibiotic therapy within 90 days
poor oral hygiene
History of rheumatic fever, History of diabetes, hepatic,  renal and immune system disease</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>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Participants in intervention group obtained a solution containing thymus vulgaris 2%. They were asked to spray solutions on to an orthodontic removable appliance.Swab from three specific of removable orthodontic appliance were taken three times: 1.At the beginning of study. 2. After two days. 3. After 5 five days.</i_keyword>
      <i_keyword>Control group: Participants in control group obtained a solution containing Chlorhexidine 0/2%. They were asked to spray solutions on to an orthodontic removable appliance. Swab from three specific of removable orthodontic appliance were taken three times:1. At the beginning of study2. After two days3. After 5 five days</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Percentage of people with Candida albicans on orthodontic removable plaque and Clinical comparison of the effect of Zataria Multiflora essential oil and Chlorhexidine on Candida albicans accumulated on orthodontic removable plaques. Timepoint: Sampling and Count of Candida albicans colonies at the beginning of the study (before intervention), 2 and 5 days after spraying with 2%Zataria Multiflora essential oil and chlorhexidine. Method of measurement: Incubator, Autoclave, Optical Microscope - Ultrasonic Bathroom.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-02-27</approval_date>
        <contact_name>Ethics committee of Azad University of Shiraz</contact_name>
        <contact_address>School of Dentistry, Shiraz Azad University, North ghaani Ave. Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
