<?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>IRCT20190915044771N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-08-26</date_registration>
      <primary_sponsor>Rasht University of Medical Sciences</primary_sponsor>
      <public_title>evaluating the effectiveness of water and liquid soap solution in cleansing of orthodontic removable appliances</public_title>
      <acronym></acronym>
      <scientific_title>Evaluating the effectiveness of water and liquid soap solution compared to chlorhexidine on microbial load reduction and microbial plaque formation on orthodontic removable appliances</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-09-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50463</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Crossover, Purpose: Health service research, Randomization description: The random allocation rule is used to assign individuals to two groups. For this reason, considering group A the removable appliances are located in water and liquid soap solution and in group B the removable appliances are located in chlorhexidine solution. Randomization was performed with R software version 3.4.3, Blinding description: performing the washing steps in each visit are done by a trained person and according to the designated protocol and the patient is not aware of the solution for washing, so it is an one-way blind study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Evaluating the effectiveness of water and liquid soap solution compared to chlorhexidine on microbial load reduction and microbial plaque formation on orthodontic removable appliances.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group A : In first referral session the orthodontic removable appliances will be washed with water and liquid soap solution, and in the second session the appliances will be washed with chlorhexidine 0.2%. Intervention 2: Intervention group B : Group A interventions for this group will be done in reverse.</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:
All data in this study can be shared.

When:
The beginning of the access period is after 1401

To whom:
The data of this study will be available for use by other researchers.

Conditions:
In the case of using the results and methods of this study, the source should be mentioned.

Where to obtain:
Dr. Yasamin Babaee Hemmati, Guilan dental school

How to obtain:
Review and satisfaction of the person responsible for the implementation of this study.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Yasamin Babaee Hemmati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Guilan dental school, Rasht</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4144693358</zip>
        <telephone>+98 13 3348 6406</telephone>
        <email>yasi.10482@gmail.com</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Yasamin Babaee hemmati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.12,Banafshe Ave,Manzarieh Blvd,Rasht</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4144693358</zip>
        <telephone>+98 13 3332 0298</telephone>
        <email>yasi.10482@gmail.com</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>patients with good general health and good oral hygiene candidate receiving treatment with orthodontic removable appliances</inclusion_criteria>
      <agemin>9 years</agemin>
      <agemax>16 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>patients with sever crowding
wide diastema
periodontal problems
severe dental caries or cavities
patients using antimicrobial mouthwashes
patients who have received antibiotics in last three months
patients with poor oral hygiene</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>Intervention group A : In first referral session the orthodontic removable appliances will be washed with water and liquid soap solution, and in the second session the appliances will be washed with chlorhexidine 0.2%.</i_keyword>
      <i_keyword>Intervention group B : Group A interventions for this group will be done in reverse.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Microbial load on orthodontic removable appliance. Timepoint: 7 days from beginning, 14 days from beginning. Method of measurement: Stained areas with disclosing agents.</prim_outcome>
      <prim_outcome>Microbial load on orthodontic removable appliance. Timepoint: 7 days from beginning, 14 days from beginning. Method of measurement: Counting the number of live bacteria.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Patient's plaque index. Timepoint: At the beginning of study (orthodontic removable appliance delivery session), 7 days from beginning, 14 days from beginning. Method of measurement: Counting the number of live bacteria.</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>Rasht University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-07-28</approval_date>
        <contact_name>Ethics commiittee of Guilan University of Medical Sciences</contact_name>
        <contact_address>No. 20, Faraz building, Fajr Alley, Namjoo Ave Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
