<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/NCT01665911</url>
  </required_header>
  <id_info>
    <org_study_id>12-I-086</org_study_id>
    <nct_id>NCT01665911</nct_id>
  </id_info>
  <brief_title>An in Situ Study on the Impact of Fluoride Dose and Concentration in Milk on Its Anti-caries Efficacy</brief_title>
  <official_title>An in Situ Study on the Impact of Fluoride Dose and Concentration in Milk on Its Anti-caries Efficacy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Frank Lippert</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Borrow Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Indiana University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study will be randomized, investigator-blind, observer-blind, laboratory analyst-blind&#xD;
      and will utilize a 5-way cross-over study design with a primary objective to determine if a&#xD;
      higher dose of fluoride in milk will provide a greater caries preventive effect. Secondary&#xD;
      objectives are to determine in a higher concentration of fluoride in milk will provide a&#xD;
      greater caries preventive effect and if the caries preventive effect of fluoridated milk&#xD;
      follows a dose-response pattern.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The evidence of milk fluoridation as a public health measure in caries prevention has been&#xD;
      demonstrated in many clinical studies. While these data are encouraging, the main focus now&#xD;
      should be on the optimization of milk fluoride programs. This protocol will concentrate on&#xD;
      the parameters of fluoride dose and concentration utilizing an in situ model, the intra-oral&#xD;
      caries test or model (ICT). The ICT is an established model which features the use of&#xD;
      gauze-covered specimens to facilitate plaque growth and to simulate a caries-prone/plaque&#xD;
      stagnation area. After subject has been consented and enrolled in the study per the&#xD;
      inclusion/exclusion criteria, two to three days following a dental cleaning, two partially&#xD;
      demineralized specimens will be placed in the buccal flange area of the subject's mandibular&#xD;
      partial denture. During each of the five, three-week test periods, subjects will drink their&#xD;
      assigned milk test product once per day for either five (100 ml milk) or ten (200 ml milk)&#xD;
      timed minutes, wearing their mandibular partial dentures 24 hours a day during the test&#xD;
      period. Fluoride free toothpaste will be used two to three days before and continuously&#xD;
      during each treatment period. After each three-week test period, the two partially&#xD;
      demineralized specimens will be removed from the subject's partial denture and analyzed using&#xD;
      the surface microhardness test. Mineral content change (as percentage of surface&#xD;
      microhardness recovery) in these artificially induced incipient enamel lesions will be the&#xD;
      primary outcome variable. Each subject (n = 28) will serve as his or her own control.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">April 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>% Surface Microhardness (SMH) Recovery Score Per Each of Five Arms</measure>
    <time_frame>Three Weeks per each of five arms</time_frame>
    <description>surface microhardness recovery is a measure of caries lesion remineralization and is calculated using the following equation:&#xD;
SMHr=(D1-R)/(D1-B)×100 B = indentation length of sound enamel specimen at baseline D1 = indentation length after first in vitro demineralization R = indentation length after intra-oral exposure (rehardening).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>% Acid Resistance Score Per Each of Five Arms</measure>
    <time_frame>Three Weeks per each of five arms</time_frame>
    <description>% Acid Resistance is a measure of acid resistance of the remineralized caries lesion which is calculated as (D1-D2)/(D1-B)*100%, where B is the indentation length of sound enamel specimen at baseline, D1 is an indentation length after first in vitro demineralization, D2 is an indentation length after second in vitro demineralization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Enamel Fluoride Uptake Per Each of Five Arms</measure>
    <time_frame>Three Weeks per each of five arms</time_frame>
    <description>Enamel fluoride uptake is a measure of fluoridation of a caries lesion</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Caries</condition>
  <arm_group>
    <arm_group_label>Arm 1</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>non-fluoridated milk, 200 ml 1.5 mg sodium fluoride in 100 ml milk, 1.5 mg sodium fluoride in 200 ml milk, 3 mg sodium fluoride in 100 ml milk, 3 mg sodium fluoride in 200 ml milk</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 2</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>non-fluoridated milk, 200 ml 1.5 mg sodium fluoride in 100 ml milk, 1.5 mg sodium fluoride in 200 ml milk, 3 mg sodium fluoride in 100 ml milk, 3 mg sodium fluoride in 200 ml milk</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 3</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>non-fluoridated milk, 200 ml 1.5 mg sodium fluoride in 100 ml milk, 1.5 mg sodium fluoride in 200 ml milk, 3 mg sodium fluoride in 100 ml milk, 3 mg sodium fluoride in 200 ml milk</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 4</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>non-fluoridated milk, 200 ml 1.5 mg sodium fluoride in 100 ml milk, 1.5 mg sodium fluoride in 200 ml milk, 3 mg sodium fluoride in 100 ml milk, 3 mg sodium fluoride in 200 ml milk</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 5</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>non-fluoridated milk, 200 ml 1.5 mg sodium fluoride in 100 ml milk, 1.5 mg sodium fluoride in 200 ml milk, 3 mg sodium fluoride in 100 ml milk, 3 mg sodium fluoride in 200 ml milk</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>1.5 mg Sodium Fluoride in 100 ml milk</intervention_name>
    <description>Each subject will use this product during one of the five treatment periods in the crossover study design.</description>
    <arm_group_label>Arm 1</arm_group_label>
    <arm_group_label>Arm 2</arm_group_label>
    <arm_group_label>Arm 3</arm_group_label>
    <arm_group_label>Arm 4</arm_group_label>
    <arm_group_label>Arm 5</arm_group_label>
    <other_name>sodium fluoride (PCCA Sodium Fluoride USP 51927-1038-00)</other_name>
    <other_name>Kroger Nonfat Dry Milk reconstituted with fluoride-free milk</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>1.5 mg sodium fluoride in 200 ml milk</intervention_name>
    <description>Each subject will use this product during one of the five treatment periods in the crossover study design.</description>
    <arm_group_label>Arm 1</arm_group_label>
    <arm_group_label>Arm 2</arm_group_label>
    <arm_group_label>Arm 3</arm_group_label>
    <arm_group_label>Arm 4</arm_group_label>
    <arm_group_label>Arm 5</arm_group_label>
    <other_name>sodium fluoride (PCCA Sodium Fluoride USP 51927-1038-00)</other_name>
    <other_name>Kroger Nonfat Dry Milk reconstituted with fluoride-free milk</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>3 mg sodium fluoride in 100 ml milk</intervention_name>
    <description>Each subject will use this product during one of the five treatment periods in the crossover study design.</description>
    <arm_group_label>Arm 1</arm_group_label>
    <arm_group_label>Arm 2</arm_group_label>
    <arm_group_label>Arm 3</arm_group_label>
    <arm_group_label>Arm 4</arm_group_label>
    <arm_group_label>Arm 5</arm_group_label>
    <other_name>sodium fluoride (PCCA Sodium Fluoride USP 51927-1038-00)</other_name>
    <other_name>Kroger Nonfat Dry Milk reconstituted with fluoride-free milk</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>3 mg sodium fluoride in 200 ml milk</intervention_name>
    <description>Each subject will use this product during one of the five treatment periods in the crossover study design</description>
    <arm_group_label>Arm 1</arm_group_label>
    <arm_group_label>Arm 2</arm_group_label>
    <arm_group_label>Arm 3</arm_group_label>
    <arm_group_label>Arm 4</arm_group_label>
    <arm_group_label>Arm 5</arm_group_label>
    <other_name>sodium fluoride (PCCA Sodium Fluoride USP 51927-1038-00)</other_name>
    <other_name>Kroger Nonfat Dry Milk reconstituted with fluoride-free milk</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Non-fluoridated milk, 200 ml</intervention_name>
    <description>Each subject will use this product during one of the five treatment periods in the crossover study design.</description>
    <arm_group_label>Arm 1</arm_group_label>
    <arm_group_label>Arm 2</arm_group_label>
    <arm_group_label>Arm 3</arm_group_label>
    <arm_group_label>Arm 4</arm_group_label>
    <arm_group_label>Arm 5</arm_group_label>
    <other_name>Kroger Nonfat Dry Milk</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  sign an informed consent, authorization for the release of health information for&#xD;
             research and provide medical history information, including medications, prior to&#xD;
             their participation;&#xD;
&#xD;
          -  be between 18 and 80 years old and in general good health;&#xD;
&#xD;
          -  willingness to use a reliable form of contraception or abstaining during the course of&#xD;
             the study (females of child-bearing potential only)&#xD;
&#xD;
          -  wear a removable mandibular partial denture with sufficient room in one posterior&#xD;
             buccal flange area to accommodate two enamel specimens (required dimensions 12×7 mm);&#xD;
&#xD;
          -  be willing and capable of wearing their removable mandibular partial dentures 24 hours&#xD;
             a day for a total of five, three-week test periods;&#xD;
&#xD;
          -  be in good dental health with no active caries or periodontal disease;&#xD;
&#xD;
          -  agree to comply with all subjects' responsibilities as stated in the protocol (e.g.&#xD;
             use of study products, attendance at appointments, etc.);&#xD;
&#xD;
          -  have a salivary flow rate in the range of normal values (unstimulated whole saliva&#xD;
             flow rate ≥ 0.2 ml/min; gum base stimulated whole saliva flow rate ≥ 0.8 ml/min).&#xD;
&#xD;
          -  Be able to tolerate the taste and room temperature of the mixed milk product as&#xD;
             demonstrated by drinking the milk at screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        be pregnant, intending to become pregnant during the study period or breast feeding. A&#xD;
        urine pregnancy test will be required at screening, the start of each treatment visit and&#xD;
        the last study visit for all subjects of child-bearing potential to confirm the subject is&#xD;
        not pregnant.&#xD;
&#xD;
          -  have any medical condition that could be expected to interfere with the subject's&#xD;
             safety during the study period;&#xD;
&#xD;
          -  demonstrate an inability to comply with study procedures;&#xD;
&#xD;
          -  have factors which could contraindicate their participation, such as any condition&#xD;
             requiring the need for antibiotic premedication prior to a dental treatment, a&#xD;
             condition requiring the need for long-term antibiotic use, blood thinning medications&#xD;
             that prohibit the safe conduct of a dental cleaning* or previous use of the weight&#xD;
             loss medications Fen Phen® or Redux®. (*Note: Subjects who are taking blood thinners&#xD;
             in which written verification is obtained from their physician indicating their PT/INR&#xD;
             levels (anti-coagulation blood levels) are at an acceptable level to avoid serious&#xD;
             complications, such as bleeding during dental cleanings, may be accepted into the&#xD;
             study at the discretion of the Investigator.)&#xD;
&#xD;
          -  be currently taking or have ever taken a bisphosphonate drug (i.e. Fosamax®, Actonel®,&#xD;
             Boniva®, Reclast®, or Zometa®) for treatment of osteoporosis.&#xD;
&#xD;
          -  be lactose intolerant or have known allergy or intolerance to milk or milk products&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Frank Lippert, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Indiana University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Domenick Zero, DDS, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Indiana University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Oral Health Research Institute, Indiana University School of Dentistry</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Lippert F, Martinez-Mier EA, Zero DT. An in situ caries study on the interplay between fluoride dose and concentration in milk. J Dent. 2014 Jul;42(7):883-90. doi: 10.1016/j.jdent.2014.01.010. Epub 2014 Feb 7.</citation>
    <PMID>24513113</PMID>
  </results_reference>
  <verification_date>February 2015</verification_date>
  <study_first_submitted>August 7, 2012</study_first_submitted>
  <study_first_submitted_qc>August 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 16, 2012</study_first_posted>
  <results_first_submitted>August 5, 2014</results_first_submitted>
  <results_first_submitted_qc>August 5, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">August 21, 2014</results_first_posted>
  <last_update_submitted>February 3, 2015</last_update_submitted>
  <last_update_submitted_qc>February 3, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 23, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Indiana University</investigator_affiliation>
    <investigator_full_name>Frank Lippert</investigator_full_name>
    <investigator_title>Assistant Research Professor</investigator_title>
  </responsible_party>
  <keyword>Caries</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Listerine</mesh_term>
    <mesh_term>Fluorides</mesh_term>
    <mesh_term>Sodium Fluoride</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>All Participants</title>
          <description>Each subject will use each of these products during each of the five treatment periods in the crossover study design. There were five interventions as follows:&#xD;
. 1.5 mg Sodium Fluoride in 100 ml milk: .&#xD;
1.5 mg Sodium Fluoride in 200 ml milk&#xD;
3.0 mg Sodium Fluoride in 100 ml milk&#xD;
3.0 mg Sodium Fluoride in 200 ml milk&#xD;
0 mg fluoride in 200 ml milk</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>0 mg Fluoride in 200 ml Milk</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>1.5 mg Sodium Fluoride in 100 ml Milk</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>1.5 mg Sodium Fluoride in 200 ml Milk</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>3.0 mg Sodium Fluoride in 100 ml Milk</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>3.0 mg Sodium Fluoride in 200 ml Milk</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>All Participants</title>
          <description>1.5 mg Sodium Fluoride in 100 ml milk: Each subject will use this product during one of the five treatment periods in the crossover study design.&#xD;
1.5 mg sodium fluoride in 200 ml milk: Each subject will use this product during one of the five treatment periods in the crossover study design.&#xD;
3 mg sodium fluoride in 100 ml milk: Each subject will use this product during one of the five treatment periods in the crossover study design.&#xD;
3 mg sodium fluoride in 200 ml milk: Each subject will use this product during one of the five treatment periods in the crossover study design&#xD;
Non-fluoridated milk, 200 ml: Each subject will use this product during one of the five treatment periods in the crossover study design</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="28"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63" spread="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>% Surface Microhardness (SMH) Recovery Score Per Each of Five Arms</title>
        <description>surface microhardness recovery is a measure of caries lesion remineralization and is calculated using the following equation:&#xD;
SMHr=(D1-R)/(D1-B)×100 B = indentation length of sound enamel specimen at baseline D1 = indentation length after first in vitro demineralization R = indentation length after intra-oral exposure (rehardening).</description>
        <time_frame>Three Weeks per each of five arms</time_frame>
        <group_list>
          <group group_id="O1">
            <title>All Participants</title>
            <description>1.5 mg sodium fluoride in 100 ml milk 1.5 mg sodium fluoride in 200 ml milk 3 mg sodium fluoride in 100 ml milk 3 mg sodium fluoride in 200 ml milk non-fluoridated milk, 200 ml&#xD;
Each of the subjects used all of the five inverventions listed above during this 5-period cross over study. Each subject had their own specific sequence of use.</description>
          </group>
        </group_list>
        <measure>
          <title>% Surface Microhardness (SMH) Recovery Score Per Each of Five Arms</title>
          <description>surface microhardness recovery is a measure of caries lesion remineralization and is calculated using the following equation:&#xD;
SMHr=(D1-R)/(D1-B)×100 B = indentation length of sound enamel specimen at baseline D1 = indentation length after first in vitro demineralization R = indentation length after intra-oral exposure (rehardening).</description>
          <units>percent</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>0 mg fluoride in 200 ml milk</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20" spread="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1.5 mg fluoride in 100 ml milk</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24" spread="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1.5 mg fluoride in 200 ml milk</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.5" spread="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3.0 mg fluoride in 100 ml milk</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.7" spread="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3.0 mg fluoride in 200 ml milk</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.4" spread="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Based on prior studies using a variety of products in this model, the within-product standard deviation of %SMH recovery is estimated to be 13% and the correlation between products is expected to be approximately 0.5. With a sample size of 28 subjects in a 5-way crossover study, the study will have 80% power to detect a %SMH recovery difference of 8.6%, assuming two-sided tests each conducted at a 5% significance level.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0490</p_value>
            <p_value_desc>Non-fluoridated milk, 200 ml vs. 1.5 mg Sodium Fluoride in 100 ml milk</p_value_desc>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.19</p_value>
            <p_value_desc>Non-fluoridated milk, 200 ml vs. 1.5 mg sodium fluoride in 200 ml milk</p_value_desc>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0017</p_value>
            <p_value_desc>Non-fluoridated milk, 200 ml vs. 3 mg sodium fluoride in 100 ml milk</p_value_desc>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0092</p_value>
            <p_value_desc>Non-fluoridated milk, 200 ml vs. 3 mg sodium fluoride in 200 ml milk</p_value_desc>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.45</p_value>
            <p_value_desc>1.5 mg Sodium Fluoride in 100 ml milk vs. 1.5 mg sodium fluoride in 200 ml milk</p_value_desc>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.18</p_value>
            <p_value_desc>1.5 mg Sodium Fluoride in 100 ml milk vs. 3 mg sodium fluoride in 100 ml milk</p_value_desc>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.47</p_value>
            <p_value_desc>1.5 mg Sodium Fluoride in 100 ml milk vs. 3 mg sodium fluoride in 200 ml milk</p_value_desc>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0423</p_value>
            <p_value_desc>1.5 mg sodium fluoride in 200 ml milk vs. 3 mg sodium fluoride in 100 ml milk</p_value_desc>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.15</p_value>
            <p_value_desc>1.5 mg sodium fluoride in 200 ml milk vs. 3 mg sodium fluoride in 200 ml milk</p_value_desc>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.54</p_value>
            <p_value_desc>3 mg sodium fluoride in 100 ml milk vs. 3 mg sodium fluoride in 200 ml milk</p_value_desc>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>% Acid Resistance Score Per Each of Five Arms</title>
        <description>% Acid Resistance is a measure of acid resistance of the remineralized caries lesion which is calculated as (D1-D2)/(D1-B)*100%, where B is the indentation length of sound enamel specimen at baseline, D1 is an indentation length after first in vitro demineralization, D2 is an indentation length after second in vitro demineralization.</description>
        <time_frame>Three Weeks per each of five arms</time_frame>
        <group_list>
          <group group_id="O1">
            <title>All Participants</title>
            <description>Each subject will use each of these products during each of the five treatment periods in the crossover study design. There were five interventions as follows:&#xD;
. 1.5 mg Sodium Fluoride in 100 ml milk: .&#xD;
1.5 mg Sodium Fluoride in 200 ml milk&#xD;
3.0 mg Sodium Fluoride in 100 ml milk&#xD;
3.0 mg Sodium Fluoride in 200 ml milk&#xD;
0 mg fluoride in 200 ml milk</description>
          </group>
        </group_list>
        <measure>
          <title>% Acid Resistance Score Per Each of Five Arms</title>
          <description>% Acid Resistance is a measure of acid resistance of the remineralized caries lesion which is calculated as (D1-D2)/(D1-B)*100%, where B is the indentation length of sound enamel specimen at baseline, D1 is an indentation length after first in vitro demineralization, D2 is an indentation length after second in vitro demineralization.</description>
          <units>percent</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>0 mg fluoride in 200 ml milk</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.4" spread="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1.5 mg fluoride in 100 ml milk</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6" spread="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1.5 mg fluoride in 200 ml milk</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2" spread="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3.0 mg fluoride in 100 ml milk</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.4" spread="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3.0 mg fluoride in 200 ml milk</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.0" spread="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.24</p_value>
            <p_value_desc>Non-fluoridated milk, 200 ml vs. 1.5 mg Sodium Fluoride in 100 ml milk</p_value_desc>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.17</p_value>
            <p_value_desc>Non-fluoridated milk, 200 ml vs. 1.5 mg sodium fluoride in 200 ml milk</p_value_desc>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0008</p_value>
            <p_value_desc>Non-fluoridated milk, 200 ml vs. 3 mg sodium fluoride in 100 ml milk</p_value_desc>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0003</p_value>
            <p_value_desc>Non-fluoridated milk, 200 ml vs. 3 mg sodium fluoride in 200 ml milk</p_value_desc>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.24</p_value>
            <p_value_desc>1.5 mg Sodium Fluoride in 100 ml milk vs. 1.5 mg Sodium Fluoride in 200 ml milk</p_value_desc>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.26</p_value>
            <p_value_desc>1.5 mg Sodium Fluoride in 100 ml milk vs. 3 mg sodium fluoride in 100 ml milk</p_value_desc>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.18</p_value>
            <p_value_desc>1.5 mg Sodium Fluoride in 100 ml milk vs. 3 mg sodium fluoride in 200 ml milk</p_value_desc>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0269</p_value>
            <p_value_desc>1.5 mg sodium fluoride in 200 ml milk vs. 3 mg sodium fluoride in 100 ml milk</p_value_desc>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0142</p_value>
            <p_value_desc>1.5 mg sodium fluoride in 200 ml milk vs. 3 mg sodium fluoride in 200 ml milk</p_value_desc>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.81</p_value>
            <p_value_desc>3 mg sodium fluoride in 100 ml milk vs. 3 mg sodium fluoride in 200 ml milk</p_value_desc>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Enamel Fluoride Uptake Per Each of Five Arms</title>
        <description>Enamel fluoride uptake is a measure of fluoridation of a caries lesion</description>
        <time_frame>Three Weeks per each of five arms</time_frame>
        <group_list>
          <group group_id="O1">
            <title>All Participants</title>
            <description>1.5 mg sodium fluoride in 100 ml milk 1.5 mg sodium fluoride in 200 ml milk 3 mg sodium fluoride in 100 ml milk 3 mg sodium fluoride in 200 ml milk non-fluoridated milk, 200 ml&#xD;
Each of the subjects used all of the five inverventions listed above during this 5-period cross over study. Each subject had their own specific sequence of use.</description>
          </group>
        </group_list>
        <measure>
          <title>Enamel Fluoride Uptake Per Each of Five Arms</title>
          <description>Enamel fluoride uptake is a measure of fluoridation of a caries lesion</description>
          <units>microgram fluoride per square cm</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>0 mg fluoride in 200 ml milk</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" spread="0.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1.5 mg fluoride in 100 ml milk</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4" spread="0.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1.5 mg fluoride in 200 ml milk</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.12" spread="0.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3.0 mg fluoride in 100 ml milk</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.09" spread="0.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3.0 mg fluoride in 200 ml milk</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.67" spread="0.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0000</p_value>
            <p_value_desc>Non-fluoridated milk, 200 ml vs. 1.5 mg Sodium Fluoride in 100 ml milk</p_value_desc>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0000</p_value>
            <p_value_desc>Non-fluoridated milk, 200 ml vs. 1.5 mg sodium fluoride in 200 ml milk</p_value_desc>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0000</p_value>
            <p_value_desc>Non-fluoridated milk, 200 ml vs. 3 mg sodium fluoride in 100 ml milk</p_value_desc>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0000</p_value>
            <p_value_desc>Non-fluoridated milk, 200 ml vs. 3 mg sodium fluoride in 200 ml milk</p_value_desc>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.14</p_value>
            <p_value_desc>1.5 mg Sodium Fluoride in 100 ml milk vs. 1.5 mg Sodium Fluoride in 200 ml milk</p_value_desc>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0012</p_value>
            <p_value_desc>1.5 mg Sodium Fluoride in 100 ml milk vs. 3 mg sodium fluoride in 100 ml milk</p_value_desc>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.19</p_value>
            <p_value_desc>1.5 mg Sodium Fluoride in 100 ml milk vs. 3 mg sodium fluoride in 200 ml milk</p_value_desc>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0000</p_value>
            <p_value_desc>1.5 mg sodium fluoride in 200 ml milk vs. 3 mg sodium fluoride in 100 ml milk</p_value_desc>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0075</p_value>
            <p_value_desc>1.5 mg sodium fluoride in 200 ml milk vs. 3 mg sodium fluoride in 200 ml milk</p_value_desc>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0444</p_value>
            <p_value_desc>3 mg sodium fluoride in 100 ml milk vs. 3 mg sodium fluoride in 200 ml milk</p_value_desc>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Six months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Arm/Group All Participants</title>
          <description>1.5 mg sodium fluoride in 100 ml milk 1.5 mg sodium fluoride in 200 ml milk 3 mg sodium fluoride in 100 ml milk 3 mg sodium fluoride in 200 ml milk non-fluoridated milk, 200 ml&#xD;
1.5 mg Sodium Fluoride in 100 ml milk: Each subject will use this product during one of the five treatment periods in the crossover study design.&#xD;
1.5 mg sodium fluoride in 200 ml milk: Each subject will use this product during one of the five treatment periods in the crossover study design.&#xD;
3 mg sodium fluoride in 100 ml milk: Each subject will use this product during one of the five treatment periods in the crossover study design.&#xD;
3 mg sodium fluoride in 200 ml milk: Each subject will use this product during one of the five treatment periods in the crossover study design&#xD;
Non-fluoridated milk, 200 ml: Each subject will use this product during one of the five treatment periods in the crossover study design.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Frank Lippert</name_or_title>
      <organization>Indiana University School of Dentistry</organization>
      <phone>317-274-8822</phone>
      <email>flippert@iu.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01665911
org study id: 12-I-086
nct id: NCT01665911
lead sponsor: 
collaborator: 
has dmc: No
The study will be randomized, investigator-blind, observer-blind, laboratory analyst-blind
      and will utilize a 5-way cross-over study design with a primary objective to determine if a
      higher dose of fluoride in milk will provide a greater caries preventive effect. Secondary
      objectives are to determine in a higher concentration of fluoride in milk will provide a
      greater caries preventive effect and if the caries preventive effect of fluoridated milk
      follows a dose-response pattern.
The evidence of milk fluoridation as a public health measure in caries prevention has been
      demonstrated in many clinical studies. While these data are encouraging, the main focus now
      should be on the optimization of milk fluoride programs. This protocol will concentrate on
      the parameters of fluoride dose and concentration utilizing an in situ model, the intra-oral
      caries test or model (ICT). The ICT is an established model which features the use of
      gauze-covered specimens to facilitate plaque growth and to simulate a caries-prone/plaque
      stagnation area. After subject has been consented and enrolled in the study per the
      inclusion/exclusion criteria, two to three days following a dental cleaning, two partially
      demineralized specimens will be placed in the buccal flange area of the subject's mandibular
      partial denture. During each of the five, three-week test periods, subjects will drink their
      assigned milk test product once per day for either five (100 ml milk) or ten (200 ml milk)
      timed minutes, wearing their mandibular partial dentures 24 hours a day during the test
      period. Fluoride free toothpaste will be used two to three days before and continuously
      during each treatment period. After each three-week test period, the two partially
      demineralized specimens will be removed from the subject's partial denture and analyzed using
      the surface microhardness test. Mineral content change (as percentage of surface
      microhardness recovery) in these artificially induced incipient enamel lesions will be the
      primary outcome variable. Each subject (n = 28) will serve as his or her own control.
allocation: Randomized
intervention model: Crossover Assignment
masking: Double (Investigator, Outcomes Assessor)
measure: % Surface Microhardness (SMH) Recovery Score Per Each of Five Arms
time frame: Three Weeks per each of five arms
description: surface microhardness recovery is a measure of caries lesion remineralization and is calculated using the following equation:
SMHr=(D1-R)/(D1-B)×100 B = indentation length of sound enamel specimen at baseline D1 = indentation length after first in vitro demineralization R = indentation length after intra-oral exposure (rehardening).
measure: % Acid Resistance Score Per Each of Five Arms
time frame: Three Weeks per each of five arms
description: % Acid Resistance is a measure of acid resistance of the remineralized caries lesion which is calculated as (D1-D2)/(D1-B)*100%, where B is the indentation length of sound enamel specimen at baseline, D1 is an indentation length after first in vitro demineralization, D2 is an indentation length after second in vitro demineralization.
measure: Enamel Fluoride Uptake Per Each of Five Arms
time frame: Three Weeks per each of five arms
description: Enamel fluoride uptake is a measure of fluoridation of a caries lesion
arm group label: Arm 1
arm group type: Other
description: non-fluoridated milk, 200 ml 1.5 mg sodium fluoride in 100 ml milk, 1.5 mg sodium fluoride in 200 ml milk, 3 mg sodium fluoride in 100 ml milk, 3 mg sodium fluoride in 200 ml milk
arm group label: Arm 2
arm group type: Other
description: non-fluoridated milk, 200 ml 1.5 mg sodium fluoride in 100 ml milk, 1.5 mg sodium fluoride in 200 ml milk, 3 mg sodium fluoride in 100 ml milk, 3 mg sodium fluoride in 200 ml milk
arm group label: Arm 3
arm group type: Other
description: non-fluoridated milk, 200 ml 1.5 mg sodium fluoride in 100 ml milk, 1.5 mg sodium fluoride in 200 ml milk, 3 mg sodium fluoride in 100 ml milk, 3 mg sodium fluoride in 200 ml milk
arm group label: Arm 4
arm group type: Other
description: non-fluoridated milk, 200 ml 1.5 mg sodium fluoride in 100 ml milk, 1.5 mg sodium fluoride in 200 ml milk, 3 mg sodium fluoride in 100 ml milk, 3 mg sodium fluoride in 200 ml milk
arm group label: Arm 5
arm group type: Active Comparator
description: non-fluoridated milk, 200 ml 1.5 mg sodium fluoride in 100 ml milk, 1.5 mg sodium fluoride in 200 ml milk, 3 mg sodium fluoride in 100 ml milk, 3 mg sodium fluoride in 200 ml milk
intervention type: Drug
intervention name: 1.5 mg Sodium Fluoride in 100 ml milk
description: Each subject will use this product during one of the five treatment periods in the crossover study design.
arm group label: Arm 1
arm group label: Arm 2
arm group label: Arm 3
arm group label: Arm 4
arm group label: Arm 5
other name: sodium fluoride (PCCA Sodium Fluoride USP 51927-1038-00)
other name: Kroger Nonfat Dry Milk reconstituted with fluoride-free milk
intervention type: Drug
intervention name: 1.5 mg sodium fluoride in 200 ml milk
description: Each subject will use this product during one of the five treatment periods in the crossover study design.
arm group label: Arm 1
arm group label: Arm 2
arm group label: Arm 3
arm group label: Arm 4
arm group label: Arm 5
other name: sodium fluoride (PCCA Sodium Fluoride USP 51927-1038-00)
other name: Kroger Nonfat Dry Milk reconstituted with fluoride-free milk
intervention type: Drug
intervention name: 3 mg sodium fluoride in 100 ml milk
description: Each subject will use this product during one of the five treatment periods in the crossover study design.
arm group label: Arm 1
arm group label: Arm 2
arm group label: Arm 3
arm group label: Arm 4
arm group label: Arm 5
other name: sodium fluoride (PCCA Sodium Fluoride USP 51927-1038-00)
other name: Kroger Nonfat Dry Milk reconstituted with fluoride-free milk
intervention type: Drug
intervention name: 3 mg sodium fluoride in 200 ml milk
description: Each subject will use this product during one of the five treatment periods in the crossover study design
arm group label: Arm 1
arm group label: Arm 2
arm group label: Arm 3
arm group label: Arm 4
arm group label: Arm 5
other name: sodium fluoride (PCCA Sodium Fluoride USP 51927-1038-00)
other name: Kroger Nonfat Dry Milk reconstituted with fluoride-free milk
intervention type: Other
intervention name: Non-fluoridated milk, 200 ml
description: Each subject will use this product during one of the five treatment periods in the crossover study design.
arm group label: Arm 1
arm group label: Arm 2
arm group label: Arm 3
arm group label: Arm 4
arm group label: Arm 5
other name: Kroger Nonfat Dry Milk
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Frank Lippert, PhD
role: Principal Investigator
affiliation: Indiana University
last name: Domenick Zero, DDS, MS
role: Principal Investigator
affiliation: Indiana University
facility: 
country: United States
citation: Lippert F, Martinez-Mier EA, Zero DT. An in situ caries study on the interplay between fluoride dose and concentration in milk. J Dent. 2014 Jul;42(7):883-90. doi: 10.1016/j.jdent.2014.01.010. Epub 2014 Feb 7.
PMID: 24513113
responsible party type: Sponsor-Investigator
investigator affiliation: Indiana University
investigator full name: Frank Lippert
investigator title: Assistant Research Professor
mesh term: Listerine
mesh term: Fluorides
mesh term: Sodium Fluoride
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 