<?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>IRCT20170828035942N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-03-05</date_registration>
      <primary_sponsor>Research center of Semnan Dental School</primary_sponsor>
      <public_title>Propolis Effect on Denture Stomatitis Treatment.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of Propolis Mouthwash and Placebo Effect  on Denture Stomatitis Treatment in Denture Wearers -A Clinical Trial Study.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-03-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/27015</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Sixty patients are randomly divided into two groups in the present research, consist of thirty case and control people. The randomizing process is done by using the random numbered bottles, according to a random numbers table. Therefore, the patient and the person who performs the clinical examination doesn't know the type of mouthwash, Blinding description: In this study, the patient, the person who gives the drug to the patient, the investigators and administrators, the person who examines the patient about the effect of the drug, the person who performs the statistical analysis, and observer are not aware of type of drugs (Propolis or placebo).</study_design>
      <phase>N/A</phase>
      <hc_freetext>denture stomatitis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Propolis mouthwash with 30% extraction, which is produced by Mashhad Tak Toos Soren Co. is employed in this investigation. An instructor firstly explained for the patients how to use the drug; that is, a dose of it must be gargled 3-5 minutes in each turn, three times a day and continue until 10 days. Then, on the first, fifth and tenth days after beginning the study, the samples are examined for the severity of the lesions in the mouth and information is recorded. Intervention 2: To fulfill the objectives of this research, a Placebo mouthwash is utilized which is prepared from the company mentioned above (distilled water and admixtures), with similar characteristics in color, odor, condition and bottles. An instructor firstly explained for the patients how to use the drug; that is, a dose of it must be gargled 3-5 minutes in each turn, three times a day and continue until 10 days. Then, on the first, fifth and tenth days after beginning the study, the samples are examined for the severity of the lesions in the mouth and information is recorded.</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. maryam jalili sadrabad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Semnan Dental School.Oral Medicine Department</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>35198-99951</zip>
        <telephone>+98 23 3333 4657</telephone>
        <email>dr.njalili@gmail.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Maryam Jalili Sadrabad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Oral Medicine Department, Semnan Dental School, Hefdah Shahrivar blvd</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>35198-99951</zip>
        <telephone>+98 23 3333 4657</telephone>
        <email>dr.njalili@gmail.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>40-80 years old
Patients with Denture Stomatitis lesions</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>B37.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>candidal stomatitis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Propolis mouthwash with 30% extraction, which is produced by Mashhad Tak Toos Soren Co. is employed in this investigation. An instructor firstly explained for the patients how to use the drug; that is, a dose of it must be gargled 3-5 minutes in each turn, three times a day and continue until 10 days. Then, on the first, fifth and tenth days after beginning the study, the samples are examined for the severity of the lesions in the mouth and information is recorded.</i_keyword>
      <i_keyword>To fulfill the objectives of this research, a Placebo mouthwash is utilized which is prepared from the company mentioned above (distilled water and admixtures), with similar characteristics in color, odor, condition and bottles. An instructor firstly explained for the patients how to use the drug; that is, a dose of it must be gargled 3-5 minutes in each turn, three times a day and continue until 10 days. Then, on the first, fifth and tenth days after beginning the study, the samples are examined for the severity of the lesions in the mouth and information is recorded.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Clinical improvement of infection. Timepoint: day 1, 5 and 10 after intervention. Method of measurement: clinical scoring.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>No need. Timepoint: no need. Method of measurement: no need.</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>Research center of Semnan Dental School</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-07-12</approval_date>
        <contact_name>Semnan University of Medical Sciences</contact_name>
        <contact_address>Vice chancellor for research, Setad Building, Basij blvd Semnan Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-08-20</approval_date>
        <contact_name>Semnan University of Medical Sciences</contact_name>
        <contact_address>Vice chancellor for research, Setad Building, Basij blvd Semnan Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
