<?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>IRCT20220525054989N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-07-31</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Comparison of the effect of cardamom herbal mouthwash with 0.2% chlorhexidine on plaque index and gingival index</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of cardamom herbal mouthwash with 0.2% chlorhexidine on plaque index and gingival index</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-06-29</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>23</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64478</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Blinding description: The person is asked to pour both mouthwash and placebo into the bottles in a uniform and opaque shape and then bring it to the researcher so that both the person being studied and the researcher do not know what type of substance is inside the bottle. Participate in the study).</study_design>
      <phase>2-3</phase>
      <hc_freetext>Gingivitis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 0.5% cardamom mouthwash group. The treatment method is that cardamom mouthwash is swirled in the mouth twice a day for two weeks and every day for 30 seconds. Plaque and gingivitis index are measured by disclosing tablet and probe before and after using the mouthwash. Mouthwash concentration is 0.5 %. The mouthwash is made by Dr. Darusaz. Intervention 2: Intervention group: 0.2% chlorhexidine mouthwash group. The treatment method is that chlorhexidine mouthwash is swirled in the mouth twice a day for two weeks and every day for 30 seconds. Plaque and gingivitis index by disclosing tablet and probe before and after using the mouthwash. The concentration of the mouthwash is 0.2% and it is prepared from a pharmacy and is of the Behsa brand. Intervention 3: Control group: Placebo (water) group. The treatment method is that the water is swirled in the mouth twice a day for two weeks and every day for 30 seconds. The index of plaque and gingivitis is measured by disclosing tablets and probes before and after consuming water. In addition, water bottles are similar to mouthwash bottles.</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 اطلاعات بیشتری وجود ندارد</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ehsan Rafiei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isfahan - Middle Tohid - Upper floor of Pasargad Bank - Negar Building 1 - 2nd floor - Unit 8</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1234567859</zip>
        <telephone>+98 913 318 2508</telephone>
        <email>dr-ehsanrafiei@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ehsan Rafiei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isfahan - Middle Tohid - Upper floor of Pasargad Bank - Negar Building 1 - 2nd floor - Unit 8</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1236459756</zip>
        <telephone>+98 913 318 2508</telephone>
        <email>dr-ehsanrafiei@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with gingivitis
Patients with symptoms of gingivitis, including gingival discoloration, bleeding when probing without loss of adhesion, and alveolar bone resorption in the probe are selected.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The patients studied should be free of any systemic disease
Do not take any medication that causes hyperplasia and bleeding gums in the last 6 months
Patients with periodontitis and recipients of periodontal treatments, smokers and pregnant women, and any other factor that affects the development and course of gum disease are excluded from the study.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K05.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic gingivitis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: 0.5% cardamom mouthwash group. The treatment method is that cardamom mouthwash is swirled in the mouth twice a day for two weeks and every day for 30 seconds. Plaque and gingivitis index are measured by disclosing tablet and probe before and after using the mouthwash. Mouthwash concentration is 0.5 %. The mouthwash is made by Dr. Darusaz.</i_keyword>
      <i_keyword>Intervention group: 0.2% chlorhexidine mouthwash group. The treatment method is that chlorhexidine mouthwash is swirled in the mouth twice a day for two weeks and every day for 30 seconds. Plaque and gingivitis index by disclosing tablet and probe before and after using the mouthwash. The concentration of the mouthwash is 0.2% and it is prepared from a pharmacy and is of the Behsa brand.</i_keyword>
      <i_keyword>Control group: Placebo (water) group. The treatment method is that the water is swirled in the mouth twice a day for two weeks and every day for 30 seconds. The index of plaque and gingivitis is measured by disclosing tablets and probes before and after consuming water. In addition, water bottles are similar to mouthwash bottles.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>"The percentage of plaque before and after using mouthwash". Timepoint: At the beginning of the study and 14 days later. Method of measurement: Disclosure tablets.</prim_outcome>
      <prim_outcome>Gingivitis before and after using mouthwash. Timepoint: At the beginning of the study and 14 days later. Method of measurement: prob.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Islamic Azad University</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_name>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-05-30</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University-Isfahan Branch (Khorasgan)</contact_name>
        <contact_address>Kerman, 33 South Jomhuri Blvd., 3 Star Complex, Unit 8 kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
