<?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>IRCT2014063018296N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-08-02</date_registration>
      <primary_sponsor>International branch of shahid beheshti university of medical sciences &amp;health services dental s</primary_sponsor>
      <public_title>The effect of two types of chewing gum containing CPP - ACP and xylitol on caries-causing bacteria in the mouth.</public_title>
      <acronym>E Ch. g CPP-ACP &amp;Z on SM</acronym>
      <scientific_title>The effect of two typs of chewing gum containing casein phosphopeptide-amorphous calcium phosphate and xylitol on amounts of streptococcus mutans.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-08-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/16637</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>Initial caries &amp; salivary mutans streptoccus.</hc_freetext>
      <i_freetext>Intervention 1: Group II: chewing gum containing CPP-ACP. After selecting individuals for entry into the study and informed consent and informed them orally A 30-member is asked daily after breakfast and after lunch and dinner take away their toothbrushes every meal a grain of chewing gum for 20 minutes and then take away the gum. These Mtah is 3 weeks. (Gum weight = 47.6 grams). Intervention 2: Group I: chewing gum containing xylitol. After selecting individuals for entry into the study and informed consent and informed them orally A 30-member is asked daily after breakfast and after lunch and dinner take away their toothbrushes every meal a grain of chewing gum for 20 minutes and then take away the gum. These Mtah is 3 weeks.  (Gum weight = 31 grams).</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link>http://journals.sbmu.ac.ir/index.php/nbm/article/view/71760</results_url_link>
      <results_summary>   Abstract Background:Dental caries is associated with oral pathogenes and Streptococcus mutans (S. mutans)is one of the primary cariogenic organisms. The aim of this clinical study was to evaluate the effect of sugar free chewing gum containing casein phosphopeptide-amorphous calcium phosphate(CPP-ACP) and Xylitol on salivary Streptococcus mutan. Materials and Methods: 60 dental students, who volunteered after signing an informed consent, were randomly allocated to receive one of the following interventions: (A) Chewing gum containing CPP-ACP, (B) Chewing gum containing Xylitol. Subjects within the experimental groups chewed gum for 20 minutes, three times a day after meals for 3 weeks. Pre- and post-intervention unstimulated saliva samples were quantified for Streptococcus mutans count. Results: A statistically significant reduction (p</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>Yosra Khaterizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dental Clinic, Shahid Beheshti Center, South Jamalzadeh st., Azadi Ave</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1454663349</zip>
        <telephone>+98 21 6691 7171</telephone>
        <email>Yosra_khaterizadeh@yahoo.com</email>
        <affiliation>International Branch of Shahid Beheshti University of Medical Sciences, Dental School</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Yosra Khaterizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dental Clinic, Shahid Beheshti Center, South Jamalzadeh st., Azadi Ave.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1454663349</zip>
        <telephone>+98 21 6691 7171</telephone>
        <email>Yosra_khaterizadeh@yahoo.com</email>
        <affiliation>International Branch of Shahid Beheshti University of Medical Sciences, Dental School</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: 1. No tooth decay or caries. 2. Lack of systemic antibiotics during the last 3 months. 3. Topical fluoride therapy during the 4-week period before baseline were not include. 4. No signs of any gingivitis or periodontal diseases. 5. Do not have habitual use of dairy xylitol or recaldent chewing gum. 6. Do not have smoking habit. 7.Have no history of systemic disease. Exclusion criterion: patients will to be excluded from the study.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>25 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K02.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Caries limited to enamel</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Group II: chewing gum containing CPP-ACP. After selecting individuals for entry into the study and informed consent and informed them orally A 30-member is asked daily after breakfast and after lunch and dinner take away their toothbrushes every meal a grain of chewing gum for 20 minutes and then take away the gum. These Mtah is 3 weeks. (Gum weight = 47.6 grams)</i_keyword>
      <i_keyword>Group I: chewing gum containing xylitol. After selecting individuals for entry into the study and informed consent and informed them orally A 30-member is asked daily after breakfast and after lunch and dinner take away their toothbrushes every meal a grain of chewing gum for 20 minutes and then take away the gum. These Mtah is 3 weeks.  (Gum weight = 31 grams)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Streptococcus mutans. Timepoint: Baseline salivary streptococcus mutans and after chewing gum salivary SM is measured. Method of measurement: Saliva is collected by sterile micro tubes.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Side effects of CPP-ACP has been not reported but people who have allergies to milk not to use the gum. Timepoint: During of study. Method of measurement: If see any signs.</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>International branch of shahid beheshti university of medical sciences &amp;health services dental s</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-07-22</approval_date>
        <contact_name>International Branch of Shahid Beheshti University of Medical Sciences, Dental School</contact_name>
        <contact_address>19 shahid abbaspour St,vali-asr Ave, Tehran-Iran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
