<?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>IRCT20130911014630N8</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-12-22</date_registration>
      <primary_sponsor>Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>A survey efficacy of Terminalia chebula  and Commiphora opobalsamum oral mouth wash on denture stomatitis</public_title>
      <acronym></acronym>
      <scientific_title>A survey efficacy of Terminalia chebula  and Commiphora opobalsamum oral mouth wash on denture stomatitis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-11-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/43025</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The mouthwash is given in containers similar to the size, taste and smell of the patients, Blinding description: The researcher, patient, and specialist physician are unaware of the type of product.</study_design>
      <phase>3</phase>
      <hc_freetext>denture stomatitis.</hc_freetext>
      <i_freetext>Intervention 1: Control group: Patients are asked to gargle 20 drops of Protact 2 times a day (morning and  afternoon) and refrain from eating and drinking for half an hour. Do not use denture during sleep and place it in a 10: 1 ratio of water and vinegar. Intervention 2: Intervention group: Patients are asked to gargle 20 drops of mouthwash twice a day (morning and afternoon) and refrain from eating and drinking for half an hour. Do not use it during sleep and place it in a container of water and vinegar at a ratio of 10 to 1 and replace your denture. The erythematous area is examined at the end of the first and second weeks and recovery is recorded in the form of denture stomatitis (type 2 to 1 conversion or complete remission).</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 Respecting patients privacy</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Mohamad Azadbakht</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Darya street</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4664117886</zip>
        <telephone>+98 11 3230 3298</telephone>
        <email>mazadbakht@mazums.ac.ir</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Mohamad Azadbakht</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Darya street</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4664117886</zip>
        <telephone>+98 11 3230 3298</telephone>
        <email>mazadbakht@mazums.ac.ir</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>patient with denture  stomatitis</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients who have a history of using antifungal, antibiotic and corticosteroid drugs, and immunosupress drugs in a recent month
patient are infected with immunosuppression disease
who are allergic to Halileh or protact mouthwash
patient who have Alzheimer's, disorders Rodent muscles and cannot rotate the mouthwash in the mouth are eliminated from the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K12</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Stomatitis and related lesions</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: Patients are asked to gargle 20 drops of Protact 2 times a day (morning and  afternoon) and refrain from eating and drinking for half an hour. Do not use denture during sleep and place it in a 10: 1 ratio of water and vinegar.</i_keyword>
      <i_keyword>Intervention group: Patients are asked to gargle 20 drops of mouthwash twice a day (morning and afternoon) and refrain from eating and drinking for half an hour. Do not use it during sleep and place it in a container of water and vinegar at a ratio of 10 to 1 and replace your denture. The erythematous area is examined at the end of the first and second weeks and recovery is recorded in the form of denture stomatitis (type 2 to 1 conversion or complete remission).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Diameter of erythema. Timepoint: end of the first and second week. Method of measurement: diameter of erythema by caliper.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Recovery duration. Timepoint: first and second week. Method of measurement: The duration of the improvements in erythema diameter by caliper.</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>Mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-05-09</approval_date>
        <contact_name>Mazandaran University of Medical Sciense research ethics committee</contact_name>
        <contact_address>Darya Street Sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
