<?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>IRCT20180714040460N8</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-04-10</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effect of curcumin mouthwash on the indicators of gingivitis and dental plaque</public_title>
      <acronym></acronym>
      <scientific_title>The effect of curcumin mouthwash on the indicators of gingivitis and dental plaque in patients referred to the School of Dentistry</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-04-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>51</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/54722</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, patients with generalized gingivitis are selected and included in the study. Patients are randomized in a block, so that packages consisting of 9 papers consisting of 3 papers from each group (3 to chlorhexidine, 3 to curcumin and 3 to control) are placed in front of the patient and the patient selects one of them randomly and enters that group, and after the completion of these 9 patients, the next patients (next 9 people) enter the study so that the process of getting sick can proceed simultaneously in all 3 groups. Next, the process of scaling and reviewing the indicators is done by a trained person who does not know what group the patient is in, so as not to be biased, Blinding description: Clinical caregivers and outcome assessors have no idea which groups the participants will be studied in.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Gingival inflammation and dental plaque.</hc_freetext>
      <i_freetext>Intervention 1: Control group: Patients who do not use any mouthwash and the desired indicators (plaque and gingivitis) are measured on the first day and then scaling and after 14 days the indicators are checked again. Intervention 2: First intervention group: Patients who are initially scaled and after measuring the indicators for 14 days use Najo chlorhexidine mouthwash for 0.2% and the indicators are evaluated 14 more times a day. People who are going to use mouthwash are told to use 10 ml of mouthwash twice a day for 30 minutes after brushing for 30 seconds and do not eat anything for 30 minutes after using the mouthwash. Intervention 3: Second Intervention group : Patients who are initially scaled and after measuring the indicators for 14 days use curcumin mouthwash 0.2% of Sina Curcumin company and the indicators are evaluated 14 times a day. People who are going to use mouthwash are told to use 10 ml of mouthwash twice a day for 30 minutes after brushing for 30 seconds and do not eat anything for 30 minutes after using the mouthwash.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyed Navid Mirazimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 1, Fifth Narenjestan Ave, Pasdaran Ave</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1957917711</zip>
        <telephone>+98 21 2282 6301</telephone>
        <email>navidmirazimi@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Nima Naddafpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Neyestan 9 Ave, Pasdaran Ave</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1946853314</zip>
        <telephone>+98 21 2256 4570</telephone>
        <email>nima.na04@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>20&gt;Age&gt;40
Dental plaque
Bleeding on probing&gt;10%
Gingivitis</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnant  women
People who have had periodontal treatment in the last 6 months
History of curcumin sensitivity
Tobacco consumers
Patients treated with systemic antibiotics</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K05</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Gingivitis and periodontal diseases</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: Patients who do not use any mouthwash and the desired indicators (plaque and gingivitis) are measured on the first day and then scaling and after 14 days the indicators are checked again.</i_keyword>
      <i_keyword>First intervention group: Patients who are initially scaled and after measuring the indicators for 14 days use Najo chlorhexidine mouthwash for 0.2% and the indicators are evaluated 14 more times a day. People who are going to use mouthwash are told to use 10 ml of mouthwash twice a day for 30 minutes after brushing for 30 seconds and do not eat anything for 30 minutes after using the mouthwash.</i_keyword>
      <i_keyword>Second Intervention group : Patients who are initially scaled and after measuring the indicators for 14 days use curcumin mouthwash 0.2% of Sina Curcumin company and the indicators are evaluated 14 times a day. People who are going to use mouthwash are told to use 10 ml of mouthwash twice a day for 30 minutes after brushing for 30 seconds and do not eat anything for 30 minutes after using the mouthwash.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Dental plaque: Determining the amount of dental plaque is evaluated based on the TURESKY index and is measured after using the disclosure pill and is expressed between 0-5 according to the presence or absence of plaque. Gingivitis: Based on the bleeding areas and based on the Modified Sulcular bleeding index is measured with a periodontal probe and is expressed between 0-3 depending on the presence or absence of bleeding. Timepoint: Day 0 and day 14. Method of measurement: Dental plaque: Determining the amount of dental plaque is evaluated based on the TURESKY index and is measured after using the disclosure pill and is expressed between 0-5 according to the presence or absence of plaque. Gingivitis: Based on the bleeding areas and based on the Modified Sulcular bleeding index is measured with a periodontal probe and is expressed between 0-3 depending on the presence or absence of bleeding.</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>2021-01-08</approval_date>
        <contact_name>Ethics Committee of Tehran Azad University of Medical Sciences</contact_name>
        <contact_address>Neyestan 9 Ave, Pasdaran Ave Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
