<?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>IRCT20171020036896N10</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-09-26</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences</primary_sponsor>
      <public_title>Assessment  the Effect of Cheese and Curd  on Salivary  pH and Calcium</public_title>
      <acronym></acronym>
      <scientific_title>Assessment  the Effect of Cheese and Curd Consumption on Salivary  pH and Calcium in Preschool Children</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-10-12</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64899</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this Study, the Simple Randomization Method (Flip the Coin) will be Used.In Such a Way that One of the Study Groups will be Considered as Heads and the Other Group will be Considered as Tails. Then the Same Number of Coins will be Thrown Based on the Sample Size. Finally, to Prevent  Disclosure of Random Sequencing, the  Allocation Concealment will be Used, Blinding description: The Biochemist in the Laboratory does not Know the Type of Compound Used in Children. The Statistics Consultant is also not Aware of the Type of Combination Used.</study_design>
      <phase>3</phase>
      <hc_freetext>Salivary pH and Calcium.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group1: In the children of the first group (15 people), complete oral prophylaxis with a rubber cap will be done in the clinic and the mouth will be washed with plain water. Then, non-stimulating children's saliva samples are collected. In this way, children are asked to empty their saliva into disposable plastic coded containers with lids. The collected samples are taken to the laboratory to measure the pH and calcium of the saliva. Then all the children in the first group are given 50 grams of curd to chew and roll it for three minutes and then swallow it. After that, the mouth will be washed with plain water and a non-stimulating saliva sample (5 cc) will be collected immediately after consumption and 30 minutes later, and will be sent to the laboratory to measure the calcium concentration and pH of the saliva. Intervention 2: Intervention group 2: In the children of the second group (15 people), complete oral prophylaxis with a rubber cap will be done in the clinic and the mouth will be washed with plain water. Then, non-stimulating children's saliva samples are collected. In this way, children are asked to empty their saliva into disposable plastic coded containers with lids. The collected samples are taken to the laboratory to measure the pH and calcium of the saliva. Then all the children in the second group are given 50 grams of chees to chew and roll it for three minutes and then swallow it. After that, the mouth will be washed with plain water and a non-stimulating saliva sample (5 cc) will be collected immediately after consumption and 30 minutes later, and will be sent to the laboratory to measure the calcium concentration and pH of the saliva.</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 The DataFile of the Participants has no Application other than Analysis</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Sadat Sajadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shafa Ave.,</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7618759689</zip>
        <telephone>+98 34 3211 8074</telephone>
        <email>fsajadi1234@gmail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Sadat Sajadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shafa Ave.,</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7618759689</zip>
        <telephone>+98 34 3211 8074</telephone>
        <email>fsajadi1234@gmail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Children with 4 to 6 Years-Old
Absence of Systemic Disease
Appropriate Cooperation to Conduct the Study</inclusion_criteria>
      <agemin>4 years</agemin>
      <agemax>6 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Using Orthodontic Appliances
Taking Antibiotics within Two Weeks Before the Start of the Study
Having Extensive Restorations and Permanent or Temporary Restorations Containing Glass Ionomer
Having an Allergy to Dairy Ingredients</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>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group1: In the children of the first group (15 people), complete oral prophylaxis with a rubber cap will be done in the clinic and the mouth will be washed with plain water. Then, non-stimulating children's saliva samples are collected. In this way, children are asked to empty their saliva into disposable plastic coded containers with lids. The collected samples are taken to the laboratory to measure the pH and calcium of the saliva. Then all the children in the first group are given 50 grams of curd to chew and roll it for three minutes and then swallow it. After that, the mouth will be washed with plain water and a non-stimulating saliva sample (5 cc) will be collected immediately after consumption and 30 minutes later, and will be sent to the laboratory to measure the calcium concentration and pH of the saliva.</i_keyword>
      <i_keyword>Intervention group 2: In the children of the second group (15 people), complete oral prophylaxis with a rubber cap will be done in the clinic and the mouth will be washed with plain water. Then, non-stimulating children's saliva samples are collected. In this way, children are asked to empty their saliva into disposable plastic coded containers with lids. The collected samples are taken to the laboratory to measure the pH and calcium of the saliva. Then all the children in the second group are given 50 grams of chees to chew and roll it for three minutes and then swallow it. After that, the mouth will be washed with plain water and a non-stimulating saliva sample (5 cc) will be collected immediately after consumption and 30 minutes later, and will be sent to the laboratory to measure the calcium concentration and pH of the saliva.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Salivary pH. Timepoint: Before, Immediately after and Half an Hour after Eating the Dairy Composition. Method of measurement: pH of saliva is Measured by pH Meter.</prim_outcome>
      <prim_outcome>Salivary  Calcium. Timepoint: Before, Immediately after and Half an Hour after Eating the Dairy Composition. Method of measurement: Calcium Concentration of Saliva is Measured by Colorimetric Method.</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>Kerman University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-11-07</approval_date>
        <contact_name>Ethical committee of Kerman University of Medical Sciences</contact_name>
        <contact_address>Ebn Sina Avenue  ,  Jahad Blvd , Kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
