<?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>IRCT20210802052055N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-09-22</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Antimicrobial efficacy of combination of chlorhexidine and Triphala mouthwashes on orthodontic patients</public_title>
      <acronym></acronym>
      <scientific_title>The antimicrobial efficacy of combination of chlorhexidine and triphala  mouthwashes on Streptococcus mutans in orthodontic patients (Randomized clinical trial)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-08-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>54</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57952</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In order to assign patients to the study groups, permuted block randomization method will be used with three patients in each block. The sample of the created list is as follows: BCA  BAC  CAB  BCA  CAB  .........
From the patients who refer to the orthodontic department, we select 54 people who meet the admission criteria and provide them with the consent form to complete.
Random allocation software was used for randomization and allocation.Each eligible patient is assigned to one of the three study groups, based on the list provided to the head of the faculty. Patients receive their mouthwash according to the letters of each block: A): Chlorhexidine: B triphala C Composite triphala and Chlorhexidine Mouthwash)
Patients will be randomly assigned to three groups.

Group 1 (n = 18): Chlorhexidine mouthwash 0.2%
Group 2 (18 people): Trifala mouthwash
Group 3 (n = 18): Mouthwash containing a mixture of 0.1% chlorhexidine and Trifala
For this purpose, mouthwash will be poured into similar plastic containers of the same size. The patient and the researcher will not be aware of the type of mouthwash, Blinding description: Mouthwash will be poured into similar plastic containers of the same size and the letters A, B, C will be written on them by the secretary of the department and will be delivered to the patients according to the randomized list. The patients and the researcher will not be aware of the type of mouthwash.</study_design>
      <phase>2</phase>
      <hc_freetext>dental caries in orthodontic patients.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The first group (n = 18): Chlorhexidine mouthwash 0.2%                                                                                                                   All patients will be asked to brush their teeth with regular toothpaste twice a day for 2-4 minutes and to rinse their mouth with 10 ml of mouthwash twice a day for 30 seconds and not to eat or drink anything for half an hour after that.The best time to use mouthwashes is before bed and after brushing. Intervention 2: Intervention group: The second group (n = 18): triphala0.06%                         All patients will be asked to brush their teeth with regular toothpaste twice a day for 2-4 minutes and to rinse their mouth with 10 ml of mouthwash twice a day for 30 seconds and not to eat or drink anything for half an hour after that.The best time to use mouthwashes is before bed and after brushing. Intervention 3: Intervention group: The third group (n = 18): Mouthwash containing 0.1% chlorhexidine mixture and triphala 0.06%                                                            All patients will be asked to brush their teeth with regular toothpaste twice a day for 2-4 minutes and to rinse their mouth with 10 ml of mouthwash twice a day for 30 seconds and not to eat or drink anything for half an hour after that.The best time to use mouthwashes is before bed and after brushing.</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:
----

When:
6 months after the results are published

To whom:
researchers of academic and scientific institutions

Conditions:
-----

Where to obtain:
-----

How to obtain:
-----

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Tabriz University of Medical Sciences</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>15th floor, Azerbaijan Tower, 17 Shahrivar Jadid Ave Tabriz</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>0</zip>
        <telephone>+98 41 3557 2636</telephone>
        <email>Hooman_sadr7@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Tabriz University of Medical Sciences</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>15th floor, Azerbaijan Tower, 17 Shahrivar Jadid Ave Tabriz</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>0</zip>
        <telephone>+98 41 3557 2636</telephone>
        <email>Hooman_sadr7@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients in the 20-60 age range
patients agreed with the informed written consent previous to the study
patients with fixed orthodontics
Do not have systemic diseases</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with dental prostheses (crown and bridge)
Patients with soft tissue pathology
Patients with poor oral health (DMFT&gt; 8)
Smokers
periodentitis
Pregnancy and Breastfeeding</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The first group (n = 18): Chlorhexidine mouthwash 0.2%                                                                                                                   All patients will be asked to brush their teeth with regular toothpaste twice a day for 2-4 minutes and to rinse their mouth with 10 ml of mouthwash twice a day for 30 seconds and not to eat or drink anything for half an hour after that.The best time to use mouthwashes is before bed and after brushing.</i_keyword>
      <i_keyword>Intervention group: The second group (n = 18): triphala0.06%                         All patients will be asked to brush their teeth with regular toothpaste twice a day for 2-4 minutes and to rinse their mouth with 10 ml of mouthwash twice a day for 30 seconds and not to eat or drink anything for half an hour after that.The best time to use mouthwashes is before bed and after brushing.</i_keyword>
      <i_keyword>Intervention group: The third group (n = 18): Mouthwash containing 0.1% chlorhexidine mixture and triphala 0.06%                                                            All patients will be asked to brush their teeth with regular toothpaste twice a day for 2-4 minutes and to rinse their mouth with 10 ml of mouthwash twice a day for 30 seconds and not to eat or drink anything for half an hour after that.The best time to use mouthwashes is before bed and after brushing.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Bacterial content. Timepoint: Before intervention - 14 days after the intervention (Using Mouthwash). Method of measurement: Colony counting unit (The number of colonies formed is counted by CFU method).</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-08-02</approval_date>
        <contact_name>Ethics committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>No10، Narges alley، Baghe Esmail Agha ave، Tohid blvd Mahabad West Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
