<?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>IRCT201207077402N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-08-25</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Using of Fluoride Varnish in caries reduction</public_title>
      <acronym></acronym>
      <scientific_title>Comparison the effectiveness of Fluoride Varnish and Casein Phosphopeptide Amorphous Calcium Phosphate (CCP-ACP) on remineralization of white spot lesions of primary teeth enamel:An in vivo study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-06-24</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>160</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/7850</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Dental caries.</hc_freetext>
      <i_freetext>Intervention 1: Fourth group: dental hygiene instruction and proper nutrition counseling along with the daily use of tooth mouse (GC, Japan). A package containing a finger toothbrush, a tube of tooth mouse and an educational pamphlet is given to the parents. The same training methods used in Group 2 is repeated.Then the method of using the mouse is taught to parents; in the way that a parent after brushing teeth, places tooth mouse by a swab twice a day (morning and night before bed) and 10 minutes (at least 3 minutes) on the teeth. The patient should be avoided from eating and drinking for half an hour . It should be mentioned that the parents are ensured that the CCP-ACP composition is derived from milk and for baby has no risk. However, if desired, parents can wash the baby's mouth after half an hour. It should be noted that the instructions are repeated every three weeks in the first 3 months in order to increase the knowledge of parents and thereafter the examinations and oral hygiene instructions is repeated each month. Intervention 2: First group: Controlled group without any remedy or hygiene and nutrition counseling In order to prevent dental caries. Intervention 3: Second group: Dental health education and advice on proper nutrition for decreasing the probability of dental caries. The cleaning of infant's teeth using a finger brush (Panbeh riz - Iran) that they are freely available, is shown face to face to the parent.Also the causes of baby bottle syndrome, its prevention methods and the pattern of proper nutrition in prevention of caries is fully explained and they are given an educational pamphlet. In this pamphlet the items such as the importance of the decidious teeth, caring and cleaning them, the impact of drinking milk at night in developing caries and … is described (attached forms). Also three posters with the focus on the importance of the deciduous teeth and the preventive methods of dental caries is prepared and hanged in health centers. It should be noted that the instructions are repeated every three weeks in the first 3 months in order to increase the knowledge of parents and thereafter the examinations and oral hygiene instructions is repeated each month. Intervention 4: Third group: dental hygiene instruction and proper nutrition counseling with the application of fluoride varnish: Initially after educating patient's parent, the teeth are cleaned with a toothbrush provided by the dentist. Then the tooth surfaces are dried using a sterile gauze and are isolated with placing the cotton rolls on vestibule. After that fluoride varnish containing sodium fluoride 5% (DuraShield, Sultan, USA) using a disposable brush is placed on all tooth surfaces and left isolated for 1 minute. Parents are advised not to use abrasive foods during the day and not to brush at night. The above procedure is repeated every 4 months. . It should be noted that the instructions are repeated every three weeks in the first 3 months in order to increase the knowledge of parents and thereafter the examinations and oral hygiene instructions is repeated each month.</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>Mahtab Memarpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pediatric Dentistry Department, Dental University,Ghomabad, Ghasrodasht,Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 71 1626 3192</telephone>
        <email>memarpour@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahtab Memarpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pediatric Department,Dental School,Ghomabad,Ghasrodasht</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 71 1626 3192</telephone>
        <email>memarpour@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: children under 3 years of age; with the eruption of at least four  anterior maxillary teeth; having white spot lesions.&#13;
Exclusion criteria: Children having  caries with cavity</inclusion_criteria>
      <agemin>1 year</agemin>
      <agemax>3 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>N/A</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Fourth group: dental hygiene instruction and proper nutrition counseling along with the daily use of tooth mouse (GC, Japan). A package containing a finger toothbrush, a tube of tooth mouse and an educational pamphlet is given to the parents. The same training methods used in Group 2 is repeated.Then the method of using the mouse is taught to parents; in the way that a parent after brushing teeth, places tooth mouse by a swab twice a day (morning and night before bed) and 10 minutes (at least 3 minutes) on the teeth. The patient should be avoided from eating and drinking for half an hour . It should be mentioned that the parents are ensured that the CCP-ACP composition is derived from milk and for baby has no risk. However, if desired, parents can wash the baby's mouth after half an hour. It should be noted that the instructions are repeated every three weeks in the first 3 months in order to increase the knowledge of parents and thereafter the examinations and oral hygiene instructions is repeated each month.</i_keyword>
      <i_keyword>First group: Controlled group without any remedy or hygiene and nutrition counseling In order to prevent dental caries.</i_keyword>
      <i_keyword>Second group: Dental health education and advice on proper nutrition for decreasing the probability of dental caries. The cleaning of infant's teeth using a finger brush (Panbeh riz - Iran) that they are freely available, is shown face to face to the parent.Also the causes of baby bottle syndrome, its prevention methods and the pattern of proper nutrition in prevention of caries is fully explained and they are given an educational pamphlet. In this pamphlet the items such as the importance of the decidious teeth, caring and cleaning them, the impact of drinking milk at night in developing caries and … is described (attached forms). Also three posters with the focus on the importance of the deciduous teeth and the preventive methods of dental caries is prepared and hanged in health centers. It should be noted that the instructions are repeated every three weeks in the first 3 months in order to increase the knowledge of parents and thereafter the examinations and oral hygiene instructions is repeated each month.</i_keyword>
      <i_keyword>Third group: dental hygiene instruction and proper nutrition counseling with the application of fluoride varnish: Initially after educating patient's parent, the teeth are cleaned with a toothbrush provided by the dentist. Then the tooth surfaces are dried using a sterile gauze and are isolated with placing the cotton rolls on vestibule. After that fluoride varnish containing sodium fluoride 5% (DuraShield, Sultan, USA) using a disposable brush is placed on all tooth surfaces and left isolated for 1 minute. Parents are advised not to use abrasive foods during the day and not to brush at night. The above procedure is repeated every 4 months. . It should be noted that the instructions are repeated every three weeks in the first 3 months in order to increase the knowledge of parents and thereafter the examinations and oral hygiene instructions is repeated each month.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Changes in enamel decalcification. Timepoint: every 3 months for one year. Method of measurement: Also dimensional changes in sizes and number of white spot will evaluate according to enamel decalcification and register in patients’ follow-up form.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>No changes in enamel decalcification. Timepoint: every 3 months for one year. Method of measurement: Also dimensional changes in sizes and number of white spot will evaluate according to enamel decalcification and register in patients’ follow-up form.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-07-03</approval_date>
        <contact_name>Shiraz University of Medical Sciences</contact_name>
        <contact_address>www.sums.ac.ir Shiraz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
