<?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>IRCT2014091319131N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-04-28</date_registration>
      <primary_sponsor>Dental School,Islamic Azad University of Isfahan(Khorasgan)</primary_sponsor>
      <public_title>comparison of the effect of probiotic yogurt and gums containing xylitol on salivary mutans streptococcus reduction</public_title>
      <acronym></acronym>
      <scientific_title>comparison of the effect of probiotic yogurt and gums containing xylitol on salivary mutans streptococcus reduction</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-04-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/17188</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Amount of salivary streptococous mutans.</hc_freetext>
      <i_freetext>Intervention 1: Group 1: 200 cc probiotic yoghurt (Kaleh) daily,for 3 weeks, 10 min after dinner. Intervention 2: Group 2: 3 times a day (after 3 meals) 2 pieces (1.86 gr Xylitol) at least for 5 min in a 3-week period Xylitol-containing chewing gum (ORION DR. XYLITOL).</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Elnaz Ghasemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dental School,Islamic Azad Universityof Isfahan(khorasgan),Jey St</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 31 3535 4053</telephone>
        <email>ghasemi_elnaz_27@yahoo.com         El.ghasemi@khuisf.ac.ir</email>
        <affiliation>Postgraduated Student,Pediatric Dentistery</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Elnaz Ghasemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dental School,Islamic Azad Universityof Isfahan(khorasgan),Jey St</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 31 3535 4053</telephone>
        <email>ghasemi_elnaz_27@yahoo.com                 El.ghasemi@khuisf.ac.ir</email>
        <affiliation>Islamic Azad Universityof Isfahan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:absence of any systemic disease ;having   105≤ CFU/ml   saliva levels of MS&#13;
Exclusion criteria: had not used antibiotics,cortons,antibacterial mouthwashes;topical fluride(except for fluoride toothpaste),within the 4-week prior to beginningof the study;used daily  probiotics and xylitol-containing chewing gums ;person with smoking and used  contraceptive drugs.</inclusion_criteria>
      <agemin>73 years</agemin>
      <agemax>58 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>A40.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other streptococcal sepsis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Group 1: 200 cc probiotic yoghurt (Kaleh) daily,for 3 weeks, 10 min after dinner.</i_keyword>
      <i_keyword>Group 2: 3 times a day (after 3 meals) 2 pieces (1.86 gr Xylitol) at least for 5 min in a 3-week period Xylitol-containing chewing gum (ORION DR. XYLITOL)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Salivary mutans sterptococcus reduction. Timepoint: Befor study, immediately one day after complete use of probiotic yoghurt and Xylitol gum (3 weeks) and also 2 &amp; 4 weeks after intervention. Method of measurement: First, saliva samples are cultured on specific medium (Mitis Salivarius Agar) using superficial culture method; eventually, the colonies are visually counted (based on the forming units of colonies in 1ml of saliva (CFU/ml)).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Reduction of dental caries. Timepoint: Before study and immediately one day after complete use of probiotic yoghurt and Xylitol gum (3weeks) and also 2 and 4 weeks after intervention. Method of measurement: ابتدا نمونه های بزاق روی محیط اختصاصی Mitis Salivarius Agar به روش کشت سطحی کشت داده خواهند شددر نهایت شمارش کلنی ها به روش چشمی انجام می شود(بر مبنای تعداد واحد تشکیل دهنده کلونی در1 میلی لیتربزاق CFU/ml).</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>Dental School,Islamic Azad University of Isfahan(Khorasgan)</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-10-15</approval_date>
        <contact_name>Islamic Azad Universityof Isfahan</contact_name>
        <contact_address>Dental School,Islamic Azad Universityof Isfahan(khorasgan),Jey Street Isfahan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
