<?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>IRCT20200905048620N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-02-09</date_registration>
      <primary_sponsor>Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of kefir drink on gingivitis</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effect of chlorhexidine mouthwash with kefir drink on clinical indices of gingivitis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-02-08</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/74915</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Using random allocation software 2, patients are distributed into two control and intervention groups using the randomized block method (blocks of 4).
The numbers of each block are placed in sealed envelopes. 
Then, according to the order of people's visits, an envelope is opened randomly and numbers are assigned to people.
 People with even numbers are assigned to the intervention group and people with odd numbers are assigned to the control group. 
This process is repeated until the last sample is selected.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Gingivitis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: This group will be given 100 ml of kefir drink for 21 days. In this study, homemade kefir drink will be used (after boiling 1.5% fat milk of Pegah Dairy Company of Iran and cooling it at room temperature, kefir grains will be It will be added, fermentation will be done at 48°C for 48 hours and then the kefir grains will be separated by filtering) and the patients will be taught to rinse their mouth twice a day for one minute for 3 weeks. Gargle the given. They will also be told to refrain from eating and drinking for half an hour and from consuming other probiotic products during the treatment period. Intervention 2: Control group: This group will be given 0.2% chlorhexidine mouthwash made by Iran Najo Company in the amount of 5 ml per day for 21 days. Patients will be instructed to gargle the given mouthwash for one minute twice a day for 3 weeks.</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:
After finishing the project, the results will be delivered in the form of a final report and electronically (on a CD) to the Research Vice-Chancellor and Faculty of Dentistry of Mazandaran University of Medical Sciences.

When:
The decision regarding the access to the data will be the responsibility of the vice chancellor of research and the Faculty of Dentistry of Mazandaran Faculty of Medical Sciences, as well as the supervisor.

To whom:
Vice chancellor of Research, Faculty of Dentistry, Mazandaran University of Medical Sciences and also a supervisor

Conditions:
To submit the final report and write the article

Where to obtain:
Vice chancellor of Research, Faculty of Dentistry, Mazandaran University of Medical Sciences and also a supervisor

How to obtain:
Written request to the research assistant or the school of
Dentistry of Mazandaran University of Medical Sciences and
obtaining the consent of the supervisor

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Leila Jabbareh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sari Dental clinic., next to Touba .,Caspian Square</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>33971-48157</zip>
        <telephone>+98 11 3329 1895</telephone>
        <email>l.jabbareh@mazums.ac.ir</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Leila Jabareh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sari Dental Clinic., next to Touba ., Caspian Square</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>33971-48157</zip>
        <telephone>+98 11 3329 1895</telephone>
        <email>l.jabbareh@mazums.ac.ir</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients who have appropriate cooperation
Patients with at least 20 functioning teeth
Patients with plaque-related gingivitis</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>People with systemic diseases
People using corticosteroids and smoking
People who are allergic to mouthwash
Poorly cooperative people
People have orthodontics and prostheses
Pregnant people
People with a history of antibiotic treatment or taking anti-inflammatory drugs in the last 3 months
People with mouth breathing habit</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K05.10</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic gingivitis, plaque induced</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: This group will be given 100 ml of kefir drink for 21 days. In this study, homemade kefir drink will be used (after boiling 1.5% fat milk of Pegah Dairy Company of Iran and cooling it at room temperature, kefir grains will be It will be added, fermentation will be done at 48°C for 48 hours and then the kefir grains will be separated by filtering) and the patients will be taught to rinse their mouth twice a day for one minute for 3 weeks. Gargle the given. They will also be told to refrain from eating and drinking for half an hour and from consuming other probiotic products during the treatment period.</i_keyword>
      <i_keyword>Control group: This group will be given 0.2% chlorhexidine mouthwash made by Iran Najo Company in the amount of 5 ml per day for 21 days. Patients will be instructed to gargle the given mouthwash for one minute twice a day for 3 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Dental plaque index. Timepoint: At the beginning of the study (before using mouthwashes) and 7 and 21 days after starting to use mouthwashes. Method of measurement: Observing and recording the plaque index of each tooth according to the Loe &amp; Silness scale table.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Gingival index. Timepoint: At the beginning of the study (before using mouthwashes) and 7, 21 days after starting to use mouthwashes. Method of measurement: Examination and recording of gingival index for each tooth according to Loe &amp; Silness scale table for gingival index.</sec_outcome>
      <sec_outcome>Gingival sulcus bleeding index. Timepoint: At the beginning of the study (before using mouthwashes) and 7, 21 days after starting to use mouthwashes. Method of measurement: Examination and recording of gingival bleeding for each tooth by periodontal probe and Muhlemann &amp; Son table.</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>2024-01-09</approval_date>
        <contact_name>Ethics Committee of Mazandaran University of Medical Sciences</contact_name>
        <contact_address>Research Vice-Chancellor ., University Building No. 2., Moalem Square., Sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
