<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03770286</url>
  </required_header>
  <id_info>
    <org_study_id>CHLA-18-00389</org_study_id>
    <nct_id>NCT03770286</nct_id>
  </id_info>
  <brief_title>Treatment of Interproximal Cavities on Primary Molar Teeth With Silver Diamine Fluoride</brief_title>
  <official_title>Treatment of Interproximal Carious Lesions on Primary Molar Teeth With SDF and Super Floss Application Versus SDF Without Super Floss Versus Fluoride Varnish Alone: a Pilot Phase 3 Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stephanie Shimizu</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Southern California</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Children's Hospital Los Angeles</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study investigates whether 1) Silver diamine fluoride (SDF) application using Super&#xD;
      Floss can arrest and/or reverse initial interproximal caries on primary molars and 2) whether&#xD;
      SDF applied with Super Floss is more effective in arresting or remineralizing initial&#xD;
      interproximal lesion in comparison to SDF applied without Super Floss or fluoride varnish&#xD;
      applied alone.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Interproximal carious lesions are challenging to control and arrest due to difficulty&#xD;
      reaching the contact area (in between teeth), limited salivary access, and poor flossing&#xD;
      compliance in children and adolescents when flossing themselves. The vast majority of caries&#xD;
      observed in children ages 5 to 10 are on interproximal surfaces.&#xD;
&#xD;
      Silver diamine fluoride (SDF) is a topical medicament touted as a very safe and noninvasive&#xD;
      alternative and/or adjunct to topical fluoride treatment or restorative treatment to halt the&#xD;
      progress (&quot;arrest&quot;) of caries. SDF has been shown to remineralize (&quot;reverse&quot;) demineralized&#xD;
      enamel or dentin, inhibit collagenases to protect dentin collagen from destruction, and have&#xD;
      bactericidal properties to cariogenic bacteria including streptococcus mutans. Normally, SDF&#xD;
      is applied with a microbrush directly on an exposed carious lesion, but due to difficulty&#xD;
      reaching interproximal carious lesions, an absorbent type of floss such as Super Floss has&#xD;
      been proposed as a delivery method for SDF application.&#xD;
&#xD;
      The purpose of this study is to investigate whether 1) SDF application using Super Floss can&#xD;
      arrest and/or reverse initial interproximal caries on primary molars and 2) whether SDF&#xD;
      applied with Super Floss is more effective in arresting or remineralizing initial&#xD;
      interproximal lesion in comparison to SDF applied without Super Floss or Fluoride varnish&#xD;
      applied alone.&#xD;
&#xD;
      The study population includes healthy children, aged 3-12, with initial interproximal decay&#xD;
      on deciduous molars identified by radiographs. In this study, initial decay is defined as&#xD;
      radiographic decay within enamel or extending to the dentin-enamel junction based on&#xD;
      International Caries Classification and Management System (ICCMS). Any eligible participant&#xD;
      will be randomly allocated to one of three treatments: Fluoride varnish (Control) application&#xD;
      alone versus SDF application without Super Floss (Control) versus SDF application with Super&#xD;
      Floss (Intervention), which will be applied at the initial visit. At 3, 6, and 12 months, the&#xD;
      participants will return for reapplication of their respective treatments. At the 6 month and&#xD;
      12 month mark, bitewing radiographs will be taken to determine status of the interested&#xD;
      lesion(s). If a lesion progresses beyond the outer 1/3 of dentin, then the patient will be&#xD;
      withdrawn and recommended routine restorative dental treatment. If a lesion arrests or&#xD;
      reverses, then the current treatment will continue until end of study duration (12 months)&#xD;
      and re-evaluated.&#xD;
&#xD;
      A statistician will be assisting us with descriptive statistics, cluster-adjusted chi-squared&#xD;
      test, and other statistics to determine if any correlation exists.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 22, 2019</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2022</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>This studies Silver Diamine Fluoride application as a treatment for interproximal caries. It also compares Super Floss and Microbrush as ways in which to apply the medicament.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Evaluator of the x-rays will be blinded.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Interproximal caries zone of radiolucency</measure>
    <time_frame>Baseline</time_frame>
    <description>Bitewing radiographs will be taken of target lesions at Day 1 (baseline). Target interproximal carious lesion(s) will be rated based on the zone of radiolucency on the radiographs using the International Caries Classification and Management System (ICCMS).&#xD;
Category 1 = Radiolucency in the outer 1/2 of enamel Category 2 = Radiolucency in the inner 1/2 of enamel Category 3 = Radiolucency in the outer 1/3 of dentin</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Interproximal caries zone of radiolucency</measure>
    <time_frame>6 months</time_frame>
    <description>Bitewing radiographs will be taken of target lesions at 6 months and compared. Target interproximal carious lesion(s) will be rated based on the zone of radiolucency on the radiographs using the International Caries Classification and Management System (ICCMS).&#xD;
Category 1 = Radiolucency in the outer 1/2 of enamel Category 2 = Radiolucency in the inner 1/2 of enamel Category 3 = Radiolucency in the outer 1/3 of dentin</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Interproximal caries zone of radiolucency</measure>
    <time_frame>12 months</time_frame>
    <description>Bitewing radiographs will be taken of target lesions at 12 months and compared. Target interproximal carious lesion(s) will be rated based on the zone of radiolucency on the radiographs using the International Caries Classification and Management System (ICCMS).&#xD;
Category 1 = Radiolucency in the outer 1/2 of enamel Category 2 = Radiolucency in the inner 1/2 of enamel Category 3 = Radiolucency in the outer 1/3 of dentin</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Dental Caries in Children</condition>
  <condition>Dental Caries Class II</condition>
  <condition>Dental Caries</condition>
  <arm_group>
    <arm_group_label>Fluoride Varnish alone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>5% sodium fluoride varnish will be applied to all teeth the day of acceptance into the study and then at 3 months, 6 months, and 12 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SDF with Super Floss</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SDF will be applied to target interproximal lesions with the use of Super Floss for 1 minute. 5% sodium fluoride varnish will then be applied to all teeth. Both will occur the day of acceptance into the study and then at 3 months, 6 months, and 12 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SDF without Super Floss</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SDF will be applied to around the (buccal, lingual, and occlusal) embrasures of the target interproximal lesions with the use of a microbrush for 1 minute. 5% sodium fluoride varnish will then be applied to all teeth. Both will occur the day of acceptance into the study and then at 3 months, 6 months, and 12 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>5% Fluoride Varnish</intervention_name>
    <description>Topical varnish</description>
    <arm_group_label>Fluoride Varnish alone</arm_group_label>
    <arm_group_label>SDF with Super Floss</arm_group_label>
    <arm_group_label>SDF without Super Floss</arm_group_label>
    <other_name>Voco ProFluorid Varnish</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>38% Silver diamine fluoride</intervention_name>
    <description>Topical varnish</description>
    <arm_group_label>SDF with Super Floss</arm_group_label>
    <arm_group_label>SDF without Super Floss</arm_group_label>
    <other_name>Advantage Arrest 38% Silver Diamine Fluoride</other_name>
    <other_name>SDF</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Floss</intervention_name>
    <description>Floss will be used as a delivery agent of SDF to target interproximal carious lesion.</description>
    <arm_group_label>SDF with Super Floss</arm_group_label>
    <other_name>Oral-B Super Floss</other_name>
    <other_name>woven floss</other_name>
    <other_name>spongy floss</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA I and ASA II children, aged 3-12&#xD;
&#xD;
          -  Behavior of 3 or 4 on Frankl scale&#xD;
&#xD;
          -  Radiographic decay within enamel or extending to the dentin-enamel junction based on&#xD;
             International Caries Classification and Management System (ICCMS) Categories 1, 2 and&#xD;
             3 &quot;Initial stages&quot;.&#xD;
&#xD;
          -  Target interproximal lesion does not have existing restoration, recurrent decay, or&#xD;
             adjacent teeth with existing restorations.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children who are not ASA I or ASA II&#xD;
&#xD;
          -  Children who are allergic to or intolerant of SDF&#xD;
&#xD;
          -  Children who have known sensitivity to silver or heavy metal-ions, or have abnormal&#xD;
             skin sensitization.&#xD;
&#xD;
          -  Children who have ulcerative gingivitis or stomatitis.&#xD;
&#xD;
          -  Carious interproximal lesions on primary molars in ICCMS Category 4, 5, or 6 18 ,&#xD;
             which signify the extent of the carious lesion radiographically reaching the middle&#xD;
             1/3 of dentin, inner 1/3 of dentin, and into the pulp respectively.&#xD;
&#xD;
          -  Behavior of a child within the Frankl 1 or 2 category, indicating a &quot;Definitely&#xD;
             Negative&quot; and &quot;Negative&quot; behavior, which may compromise safe application of SDF.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stephanie Shimizu, DDS</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHLA, USC</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Stephanie Shimizu, DDS</last_name>
    <phone>925-787-6981</phone>
    <email>sshimizu@chla.usc.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Alexander Alcaraz, DDS</last_name>
    <phone>323-361-2130</phone>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Childrens Hospital Los Angeles</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90027</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stephanie Shimizu, DDS</last_name>
      <phone>925-787-6981</phone>
      <email>sshimizu@chla.usc.edu</email>
    </contact>
    <contact_backup>
      <last_name>Alexander R Alcaraz, DMD</last_name>
      <phone>323-361-2130</phone>
      <email>aalcaraz@chla.usc.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Horst JA, Ellenikiotis H, Milgrom PL. UCSF Protocol for Caries Arrest Using Silver Diamine Fluoride: Rationale, Indications and Consent. J Calif Dent Assoc. 2016 Jan;44(1):16-28.</citation>
    <PMID>26897901</PMID>
  </reference>
  <reference>
    <citation>Rosenblatt A, Stamford TC, Niederman R. Silver diamine fluoride: a caries &quot;silver-fluoride bullet&quot;. J Dent Res. 2009 Feb;88(2):116-25. doi: 10.1177/0022034508329406.</citation>
    <PMID>19278981</PMID>
  </reference>
  <reference>
    <citation>Sihra R, Schroth RJ, Bertone M, Martin H, Patterson B, Mittermuller BA, Lee V, Patterson B, Moffatt ME, Klus B, Fontana M, Robertson L. The Effectiveness of Silver Diamine Fluoride and Fluoride Varnish in Arresting Caries in Young Children and Associated Oral Health-Related Quality of Life. J Can Dent Assoc. 2020 Jun;86:k9.</citation>
    <PMID>32543369</PMID>
  </reference>
  <reference>
    <citation>Hammersmith KJ, DePalo JR, Casamassimo PS, MacLean JK, Peng J. Silver Diamine Fluoride and Fluoride Varnish May Halt Interproximal Caries Progression in the Primary Dentition. J Clin Pediatr Dent. 2020;44(2):79-83. doi: 10.17796/1053-4625-44.2.2.</citation>
    <PMID>32271666</PMID>
  </reference>
  <reference>
    <citation>Schwendicke F, Meyer-Lueckel H, Stolpe M, Dorfer CE, Paris S. Costs and effectiveness of treatment alternatives for proximal caries lesions. PLoS One. 2014 Jan 27;9(1):e86992. doi: 10.1371/journal.pone.0086992. eCollection 2014.</citation>
    <PMID>24475208</PMID>
  </reference>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <last_update_submitted>August 6, 2022</last_update_submitted>
  <last_update_submitted_qc>August 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Children's Hospital Los Angeles</investigator_affiliation>
    <investigator_full_name>Stephanie Shimizu</investigator_full_name>
    <investigator_title>Pediatric Dental Resident</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dental Caries</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fluorides</mesh_term>
    <mesh_term>Fluorides, Topical</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03770286
org study id: CHLA-18-00389
nct id: NCT03770286
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
This study investigates whether 1) Silver diamine fluoride (SDF) application using Super
      Floss can arrest and/or reverse initial interproximal caries on primary molars and 2) whether
      SDF applied with Super Floss is more effective in arresting or remineralizing initial
      interproximal lesion in comparison to SDF applied without Super Floss or fluoride varnish
      applied alone.
Interproximal carious lesions are challenging to control and arrest due to difficulty
      reaching the contact area (in between teeth), limited salivary access, and poor flossing
      compliance in children and adolescents when flossing themselves. The vast majority of caries
      observed in children ages 5 to 10 are on interproximal surfaces.

      Silver diamine fluoride (SDF) is a topical medicament touted as a very safe and noninvasive
      alternative and/or adjunct to topical fluoride treatment or restorative treatment to halt the
      progress ("arrest") of caries. SDF has been shown to remineralize ("reverse") demineralized
      enamel or dentin, inhibit collagenases to protect dentin collagen from destruction, and have
      bactericidal properties to cariogenic bacteria including streptococcus mutans. Normally, SDF
      is applied with a microbrush directly on an exposed carious lesion, but due to difficulty
      reaching interproximal carious lesions, an absorbent type of floss such as Super Floss has
      been proposed as a delivery method for SDF application.

      The purpose of this study is to investigate whether 1) SDF application using Super Floss can
      arrest and/or reverse initial interproximal caries on primary molars and 2) whether SDF
      applied with Super Floss is more effective in arresting or remineralizing initial
      interproximal lesion in comparison to SDF applied without Super Floss or Fluoride varnish
      applied alone.

      The study population includes healthy children, aged 3-12, with initial interproximal decay
      on deciduous molars identified by radiographs. In this study, initial decay is defined as
      radiographic decay within enamel or extending to the dentin-enamel junction based on
      International Caries Classification and Management System (ICCMS). Any eligible participant
      will be randomly allocated to one of three treatments: Fluoride varnish (Control) application
      alone versus SDF application without Super Floss (Control) versus SDF application with Super
      Floss (Intervention), which will be applied at the initial visit. At 3, 6, and 12 months, the
      participants will return for reapplication of their respective treatments. At the 6 month and
      12 month mark, bitewing radiographs will be taken to determine status of the interested
      lesion(s). If a lesion progresses beyond the outer 1/3 of dentin, then the patient will be
      withdrawn and recommended routine restorative dental treatment. If a lesion arrests or
      reverses, then the current treatment will continue until end of study duration (12 months)
      and re-evaluated.

      A statistician will be assisting us with descriptive statistics, cluster-adjusted chi-squared
      test, and other statistics to determine if any correlation exists.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This studies Silver Diamine Fluoride application as a treatment for interproximal caries. It also compares Super Floss and Microbrush as ways in which to apply the medicament.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Evaluator of the x-rays will be blinded.
measure: Interproximal caries zone of radiolucency
time frame: Baseline
description: Bitewing radiographs will be taken of target lesions at Day 1 (baseline). Target interproximal carious lesion(s) will be rated based on the zone of radiolucency on the radiographs using the International Caries Classification and Management System (ICCMS).
Category 1 = Radiolucency in the outer 1/2 of enamel Category 2 = Radiolucency in the inner 1/2 of enamel Category 3 = Radiolucency in the outer 1/3 of dentin
measure: Interproximal caries zone of radiolucency
time frame: 6 months
description: Bitewing radiographs will be taken of target lesions at 6 months and compared. Target interproximal carious lesion(s) will be rated based on the zone of radiolucency on the radiographs using the International Caries Classification and Management System (ICCMS).
Category 1 = Radiolucency in the outer 1/2 of enamel Category 2 = Radiolucency in the inner 1/2 of enamel Category 3 = Radiolucency in the outer 1/3 of dentin
measure: Interproximal caries zone of radiolucency
time frame: 12 months
description: Bitewing radiographs will be taken of target lesions at 12 months and compared. Target interproximal carious lesion(s) will be rated based on the zone of radiolucency on the radiographs using the International Caries Classification and Management System (ICCMS).
Category 1 = Radiolucency in the outer 1/2 of enamel Category 2 = Radiolucency in the inner 1/2 of enamel Category 3 = Radiolucency in the outer 1/3 of dentin
arm group label: Fluoride Varnish alone
arm group type: Active Comparator
description: 5% sodium fluoride varnish will be applied to all teeth the day of acceptance into the study and then at 3 months, 6 months, and 12 months.
arm group label: SDF with Super Floss
arm group type: Experimental
description: SDF will be applied to target interproximal lesions with the use of Super Floss for 1 minute. 5% sodium fluoride varnish will then be applied to all teeth. Both will occur the day of acceptance into the study and then at 3 months, 6 months, and 12 months.
arm group label: SDF without Super Floss
arm group type: Experimental
description: SDF will be applied to around the (buccal, lingual, and occlusal) embrasures of the target interproximal lesions with the use of a microbrush for 1 minute. 5% sodium fluoride varnish will then be applied to all teeth. Both will occur the day of acceptance into the study and then at 3 months, 6 months, and 12 months.
intervention type: Device
intervention name: 5% Fluoride Varnish
description: Topical varnish
arm group label: Fluoride Varnish alone
arm group label: SDF with Super Floss
arm group label: SDF without Super Floss
other name: Voco ProFluorid Varnish
intervention type: Device
intervention name: 38% Silver diamine fluoride
description: Topical varnish
arm group label: SDF with Super Floss
arm group label: SDF without Super Floss
other name: Advantage Arrest 38% Silver Diamine Fluoride
other name: SDF
intervention type: Device
intervention name: Floss
description: Floss will be used as a delivery agent of SDF to target interproximal carious lesion.
arm group label: SDF with Super Floss
other name: Oral-B Super Floss
other name: woven floss
other name: spongy floss
criteria: 
gender: All
minimum age: 3 Years
maximum age: 12 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Stephanie Shimizu, DDS
role: Principal Investigator
affiliation: CHLA, USC
last name: Stephanie Shimizu, DDS
phone: 925-787-6981
email: sshimizu@chla.usc.edu
last name: Alexander Alcaraz, DDS
phone: 323-361-2130
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
citation: Horst JA, Ellenikiotis H, Milgrom PL. UCSF Protocol for Caries Arrest Using Silver Diamine Fluoride: Rationale, Indications and Consent. J Calif Dent Assoc. 2016 Jan;44(1):16-28.
PMID: 26897901
citation: Rosenblatt A, Stamford TC, Niederman R. Silver diamine fluoride: a caries "silver-fluoride bullet". J Dent Res. 2009 Feb;88(2):116-25. doi: 10.1177/0022034508329406.
PMID: 19278981
citation: Sihra R, Schroth RJ, Bertone M, Martin H, Patterson B, Mittermuller BA, Lee V, Patterson B, Moffatt ME, Klus B, Fontana M, Robertson L. The Effectiveness of Silver Diamine Fluoride and Fluoride Varnish in Arresting Caries in Young Children and Associated Oral Health-Related Quality of Life. J Can Dent Assoc. 2020 Jun;86:k9.
PMID: 32543369
citation: Hammersmith KJ, DePalo JR, Casamassimo PS, MacLean JK, Peng J. Silver Diamine Fluoride and Fluoride Varnish May Halt Interproximal Caries Progression in the Primary Dentition. J Clin Pediatr Dent. 2020;44(2):79-83. doi: 10.17796/1053-4625-44.2.2.
PMID: 32271666
citation: Schwendicke F, Meyer-Lueckel H, Stolpe M, Dorfer CE, Paris S. Costs and effectiveness of treatment alternatives for proximal caries lesions. PLoS One. 2014 Jan 27;9(1):e86992. doi: 10.1371/journal.pone.0086992. eCollection 2014.
PMID: 24475208
responsible party type: Sponsor-Investigator
investigator affiliation: Children's Hospital Los Angeles
investigator full name: Stephanie Shimizu
investigator title: Pediatric Dental Resident
mesh term: Dental Caries
mesh term: Fluorides
mesh term: Fluorides, Topical
sharing ipd: No