<?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>IRCT20180714040460N7</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-03-03</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Evaluation of carcinogenicity of chlorhexidine mouthwash on oral mucosa</public_title>
      <acronym></acronym>
      <scientific_title>Investigation of the relationship between chlorhexidine mouthwash and nuclear changes in buccal mucosa in people with gingivitis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-04-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/54677</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Prevention.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Carcinogenic effect of chlorhexidine mouthwash.</hc_freetext>
      <i_freetext>Intervention group: To evaluate the toxicity of chlorhexidine mouthwash and to diagnose its carcinogenicity, chlorhexidine mouthwash 0/2٪ 250 ml has been prepared by Najo Company and is supposed to refer to 50 patients of who refer to the periodontology department of Azad University of Tehran . Phase one should be treated by rinsing your mouth thoroughly with water before scaling, and a layer of cells is removed from the surface of the buccal mucosa of the mouth with a wet swab and applied to a clean, sterile slide. The slide is placed, then we fix it with spray fix, and then the mouthwash is rotated twice a day and night after brushing, each time 10 ml of solution,by time 30 seconds  ,turned in mouth and Then emptied. The second session of treatment, which is one week later, will take the second sample . both samples after the steps of Pap smear and fixation and nucleus staining and dehydration, we will count  nuclear changes of micronucleus, karyorexis, karyolysis and broken eggs with light microscopy.then we can judge the result..</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:
Investigation of the relationship between chlorhexidine mouthwash and nuclear changes Buccal mucosa in people with gingivitis

When:
6 mounths after printing the results

To whom:
All people who needs data

Conditions:
The analysis that do not damage the outcome of our data analysis are allowed

Where to obtain:
Faculty of Dentistry, Islamic Azad University of Iran

How to obtain:
Refer to Tehran Azad Dental School and apply there and have access to the data for a maximum of 2 weeks

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nima Nadaf Pour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No9,9th Neyestan Alley,Pasdaran Street,Tehran,Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1946853314</zip>
        <telephone>+98 21 2256 4571</telephone>
        <email>N_nadaf@dentaliau.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nima Nadaf Pour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No9,9th Neyestan Alley,Pasdaran street,Tehran,Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1946853314</zip>
        <telephone>+98 21 2256 4571</telephone>
        <email>N_nadaf@dentaliau.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Be in the treatment of phase one gingivitis
be between 20-30 years old
Have gingivitis</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The smoking group includes samples with a history of consumption of more than 5 years and above 20 cigarettes per day that are considered Heavy Smoker
criteria for taking certain drugs (such as antiretrovirals, doses containing statins, ..)
Drug addiction
engaging in high-risk occupations such as the paint industry, etc
recent viral illness
Undergoing radiotherapy or Less than one year history for radiotherapy</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: To evaluate the toxicity of chlorhexidine mouthwash and to diagnose its carcinogenicity, chlorhexidine mouthwash 0/2٪ 250 ml has been prepared by Najo Company and is supposed to refer to 50 patients of who refer to the periodontology department of Azad University of Tehran . Phase one should be treated by rinsing your mouth thoroughly with water before scaling, and a layer of cells is removed from the surface of the buccal mucosa of the mouth with a wet swab and applied to a clean, sterile slide. The slide is placed, then we fix it with spray fix, and then the mouthwash is rotated twice a day and night after brushing, each time 10 ml of solution,by time 30 seconds  ,turned in mouth and Then emptied. The second session of treatment, which is one week later, will take the second sample . both samples after the steps of Pap smear and fixation and nucleus staining and dehydration, we will count  nuclear changes of micronucleus, karyorexis, karyolysis and broken eggs with light microscopy.then we can judge the result.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Micronucleus. Timepoint: Before scaling and one week after using chlorhexidine mouthwash. Method of measurement: Cell count with light microscope with 400 magnification.</prim_outcome>
      <prim_outcome>Karyorrehxis. Timepoint: Before scaling and one week after using chlorhexidine mouthwash. Method of measurement: count with light microscope with 400 magnification.</prim_outcome>
      <prim_outcome>Karyolysis. Timepoint: Before scaling and one week after using chlorhexidine mouthwash. Method of measurement: count with light microscope with 400 magnification.</prim_outcome>
      <prim_outcome>Broken egg. Timepoint: Before scaling and one week after using chlorhexidine mouthwash. Method of measurement: count with light microscope with 400 magnification.</prim_outcome>
      <prim_outcome>Repair index. Timepoint: It is calculated after counting nuclear changes. Method of measurement: Mean karyolysis and karyorexia divided by the mean of micronucleus and Broken ag.</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 of Tehran</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-06-01</approval_date>
        <contact_name>Faculty of Dentistry, Islamic Azad University, Tehran Branch</contact_name>
        <contact_address>No. 9, Neystan Alley, Pasdaran St., Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
