<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/NCT02195583</url>
  </required_header>
  <id_info>
    <org_study_id>202194</org_study_id>
    <secondary_id>RH02437</secondary_id>
    <nct_id>NCT02195583</nct_id>
  </id_info>
  <brief_title>The Effect of Experimental Dentifrices on Remineralization of Caries Lesions In-situ</brief_title>
  <official_title>The Effect of Experimental Dentifrices on Remineralization of Caries Lesions In-situ</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the effect of experimental sodium fluoride-silica dentifrice&#xD;
      formulations, with and without zinc, on remineralization of enamel in situ. Following the&#xD;
      remineralization phase, the acid resistance of the new mineral formed will be assessed.&#xD;
      Fluoride uptake during the remineralization phase will also be measured.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">August 2014</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage Surface Microhardness Recovery (% SMHR)</measure>
    <time_frame>Baseline to 4 hours</time_frame>
    <description>Changes in the mineral content of the four centrally-located enamel specimens were evaluated using the Surface Microhardness (SMH) Test. The SMH was measured using a Wilson 2100 Hardness Tester. The baseline SMH was determined prior to the in vitro acid challenge. SMH was determined again after the in vitro acid challenge, after the in situ remineralization test, and again after the second in vitro acid challenge. The extent of remineralization was calculated as the % recovery in SMH using the equation: % SMHR= [(D1-R)/(D1-B)]*100 Where B = indentation length (μm) of sound enamel at baseline; D1 = indentation length (μm) after first acid challenge; R = indentation length (μm) after in situ remineralization.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Enamel Fluoride Uptake</measure>
    <time_frame>Baseline to 4 hours</time_frame>
    <description>The microdrill enamel biopsy technique was used to analyze the fluoride uptake by enamel. Each enamel specimen was mounted on the long axis of a drill attached to a microdrill and drilled to a depth of approximately 100 micrometer (μm) through the entire lesion (four cores per specimen). The enamel powder pooled from four drilling sample was then immediately analyzed for fluoride content using fluoride specific electrode and pH/ion meter. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores and expressed as microgram per square centimeter (μg/cm^2).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage Net Acid Resistance (% NAR)</measure>
    <time_frame>Baseline to 4 hours</time_frame>
    <description>Changes in the mineral content of the four centrally-located enamel specimens were evaluated using the SMH Test. The SMH was measured using a Wilson 2100 Hardness Tester. The baseline SMH was measured prior to the in vitro acid challenge. SMH was measured again after the in vitro acid challenge, after the in situ remineralization test, and again after the second in vitro acid challenge. The % NAR was calculated using the equation: % NAR= [(D1-D2)/(D1-B)]*100 where B= Indentation length (μm) of sound enamel at baseline; D1= Indentation length (μm) after first acid challenge and D2= Indentation length (μm) after second acid challenge.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage Comparative Acid Resistance (% CAR)</measure>
    <time_frame>Baseline to 4 hours</time_frame>
    <description>Changes in the mineral content of the four centrally-located enamel specimens were evaluated using the SMH Test. The SMH was measured using a Wilson 2100 Hardness Tester. The baseline SMH was measured prior to the in vitro acid challenge. SMH was measured again after the in vitro acid challenge, after the in situ remineralization test, and again after the second in vitro acid challenge. The % CAR was calculated using the equation: % CAR= [(D2-R)/(D1-B)]*100 where B= Indentation length (μm) of sound enamel at baseline; R= Indentation length (μm) of enamel after in situ remineralization; D1= Indentation length (μm) after first acid challenge; D2= Indentation length (μm) after second acid challenge.</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">62</enrollment>
  <condition>Oral Hygiene</condition>
  <arm_group>
    <arm_group_label>Sodium fluoride (1426 ppm)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Non-zinc, 1426ppm fluoride as sodium fluoride in a silica gel base</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sodium fluoride (1150 ppm)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Non-zinc, 1150ppm fluoride as sodium fluoride in a silica gel base</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sodium fluoride (250 ppm)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Non-zinc, 250ppm fluoride as sodium fluoride in a silica gel base</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sodium fluoride (1426 ppm) + zinc base A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Zinc base A, 1426ppm fluoride as sodium fluoride in a silica gel base</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sodium fluoride (1426 ppm) + zinc base B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Zinc base B, 1426ppm fluoride as sodium fluoride in a silica gel base</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fluoride (0 ppm)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Non-zinc, 0ppm fluoride in a silica gel base</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sodium fluoride (1426 ppm)</intervention_name>
    <description>Non-zinc, 1426ppm fluoride as sodium fluoride in a silica gel base</description>
    <arm_group_label>Sodium fluoride (1426 ppm)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sodium fluoride (1150 ppm)</intervention_name>
    <description>Non-zinc, 1150ppm fluoride as sodium fluoride in a silica gel base</description>
    <arm_group_label>Sodium fluoride (1150 ppm)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sodium fluoride (250 ppm)</intervention_name>
    <description>Non-zinc, 250ppm fluoride as sodium fluoride in a silica gel base</description>
    <arm_group_label>Sodium fluoride (250 ppm)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sodium fluoride (1426 ppm) + zinc base A</intervention_name>
    <description>Zinc base A, 1426ppm fluoride as sodium fluoride in a silica gel base</description>
    <arm_group_label>Sodium fluoride (1426 ppm) + zinc base A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sodium fluoride (1426 ppm) + zinc base B</intervention_name>
    <description>Zinc base B, 1426ppm fluoride as sodium fluoride in a silica gel base</description>
    <arm_group_label>Sodium fluoride (1426 ppm) + zinc base B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fluoride (0 ppm)</intervention_name>
    <description>Non-zinc, 0ppm fluoride in a silica gel base</description>
    <arm_group_label>Fluoride (0 ppm)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Good general health with no clinically significant and relevant abnormalities of&#xD;
             medical history or oral examination&#xD;
&#xD;
          -  Participants with maxillary dental arch suitable for the retention of the palatal&#xD;
             appliance&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants taking fluoride supplement&#xD;
&#xD;
          -  Pregnant or breast-feeding women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GSK Investigational Site</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>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>July 17, 2014</study_first_submitted>
  <study_first_submitted_qc>July 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 21, 2014</study_first_posted>
  <results_first_submitted>March 26, 2015</results_first_submitted>
  <results_first_submitted_qc>March 26, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">April 7, 2015</results_first_posted>
  <last_update_submitted>April 9, 2015</last_update_submitted>
  <last_update_submitted_qc>April 9, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 1, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Zinc</mesh_term>
    <mesh_term>Listerine</mesh_term>
    <mesh_term>Fluorides</mesh_term>
    <mesh_term>Sodium Fluoride</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were recruited at one clinical study site in the USA.</recruitment_details>
      <pre_assignment_details>A total of 64 participants were screened and 62 were randomized.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Overall Participants</title>
          <description>Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 seconds (sec) to create dentifrice slurry. Then swished the slurry around the palatal appliance for 1 minute (min) and 35 sec. Next, they expectorated the slurry, rinsed with 15 milliliter (mL) of tap water for 10 sec and expectorated. There was a 2 day washout period before each treatment period when participants used a non-fluoridated dentifrice.&#xD;
Sodium fluoride (1426 ppm):Non-zinc, 1426ppm fluoride as sodium fluoride in silica base&#xD;
Sodium fluoride (1150 ppm):Non-zinc, 1150ppm fluoride as sodium fluoride in silica base&#xD;
Sodium fluoride (250 ppm):Non-zinc, 250ppm fluoride as sodium fluoride in silica base&#xD;
Sodium fluoride (1426 ppm) + zinc base A:Zinc base A, 1426ppm fluoride as sodium fluoride in silica base&#xD;
Sodium fluoride (1426 ppm) + zinc base B:Zinc base B, 1426ppm fluoride as sodium fluoride in silica base&#xD;
Sodium fluoride (0 ppm):Non-zinc, 0ppm fluoride in silica base</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="62"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Sodium Fluoride (1150 Ppm)</title>
              <participants_list>
                <participants group_id="P1" count="57">Discontinuations: 1 due to other reason in Period 5</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>Sodium Fluoride (0 Ppm)</title>
              <participants_list>
                <participants group_id="P1" count="59"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Sodium Fluoride (1426 Ppm) + Zinc Base A</title>
              <participants_list>
                <participants group_id="P1" count="58">Discontinuations: 1 withdrawal of consent in Period 3 and 1 withdrawal of consent in Period 4</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>Sodium Fluoride (250 Ppm)</title>
              <participants_list>
                <participants group_id="P1" count="55"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Sodium Fluoride (1426 Ppm)</title>
              <participants_list>
                <participants group_id="P1" count="59">Discontinuation:1 lost to follow up, 1 withdrawal of consent in Period 2, 1 other reason in Period 5</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>Sodium Fluoride (1426 Ppm) + Zinc Base B</title>
              <participants_list>
                <participants group_id="P1" count="60">Discontinuations: 1 withdrawal of consent in Period 2;1 adverse event each in Period 3 and Period 4</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="53"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other Reason</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All randomized participants were evaluated for baseline characteristics</population>
      <group_list>
        <group group_id="B1">
          <title>All Randomized Participants</title>
          <description>All randomized participants were evaluated for baseline characteristics</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="62"/>
          </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="40.7" spread="12.03"/>
                  </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="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage Surface Microhardness Recovery (% SMHR)</title>
        <description>Changes in the mineral content of the four centrally-located enamel specimens were evaluated using the Surface Microhardness (SMH) Test. The SMH was measured using a Wilson 2100 Hardness Tester. The baseline SMH was determined prior to the in vitro acid challenge. SMH was determined again after the in vitro acid challenge, after the in situ remineralization test, and again after the second in vitro acid challenge. The extent of remineralization was calculated as the % recovery in SMH using the equation: % SMHR= [(D1-R)/(D1-B)]*100 Where B = indentation length (μm) of sound enamel at baseline; D1 = indentation length (μm) after first acid challenge; R = indentation length (μm) after in situ remineralization.</description>
        <time_frame>Baseline to 4 hours</time_frame>
        <population>The primary population for the efficacy analysis was the Per Protocol (PP) population, including participants with a protocol violation affecting some (but not all) of the efficacy assessments. However, data from assessments when a violation occurred were excluded.</population>
        <group_list>
          <group group_id="O1">
            <title>Sodium Fluoride (1426 Ppm)</title>
            <description>Non-zinc, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.</description>
          </group>
          <group group_id="O2">
            <title>Sodium Fluoride (1150 Ppm)</title>
            <description>Non-zinc, 1150ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.</description>
          </group>
          <group group_id="O3">
            <title>Sodium Fluoride (250 Ppm)</title>
            <description>Non-zinc, 250ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.</description>
          </group>
          <group group_id="O4">
            <title>Sodium Fluoride (1426 Ppm) + Zinc Base A</title>
            <description>Zinc base A, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.</description>
          </group>
          <group group_id="O5">
            <title>Sodium Fluoride (1426 Ppm) + Zinc Base B</title>
            <description>Zinc base B, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.</description>
          </group>
          <group group_id="O6">
            <title>Sodium Fluoride (0 Ppm)</title>
            <description>Non-zinc, 0ppm fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage Surface Microhardness Recovery (% SMHR)</title>
          <description>Changes in the mineral content of the four centrally-located enamel specimens were evaluated using the Surface Microhardness (SMH) Test. The SMH was measured using a Wilson 2100 Hardness Tester. The baseline SMH was determined prior to the in vitro acid challenge. SMH was determined again after the in vitro acid challenge, after the in situ remineralization test, and again after the second in vitro acid challenge. The extent of remineralization was calculated as the % recovery in SMH using the equation: % SMHR= [(D1-R)/(D1-B)]*100 Where B = indentation length (μm) of sound enamel at baseline; D1 = indentation length (μm) after first acid challenge; R = indentation length (μm) after in situ remineralization.</description>
          <population>The primary population for the efficacy analysis was the Per Protocol (PP) population, including participants with a protocol violation affecting some (but not all) of the efficacy assessments. However, data from assessments when a violation occurred were excluded.</population>
          <units>Percentage of SMHR</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="59"/>
                <count group_id="O2" value="57"/>
                <count group_id="O3" value="55"/>
                <count group_id="O4" value="58"/>
                <count group_id="O5" value="60"/>
                <count group_id="O6" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.49" spread="1.167"/>
                    <measurement group_id="O2" value="31.81" spread="1.182"/>
                    <measurement group_id="O3" value="27.56" spread="1.199"/>
                    <measurement group_id="O4" value="22.62" spread="1.175"/>
                    <measurement group_id="O5" value="23.22" spread="1.159"/>
                    <measurement group_id="O6" value="24.78" spread="1.167"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Linear contrasts were fitted in order to establish whether there was a dose-response relationship. Linear contrasts were for experimental dentifrice: non-zinc treatments.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>ANOVA</method>
            <method_desc>Calculated from Analysis of Variance (ANOVA) model using treatment and study period as fixed factors and participant as random effect.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Quadratic contrasts were fitted in order to establish whether there was a dose-response relationship. Quadratic contrasts are for experimental dentifrice: non-zinc treatments.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.2274</p_value>
            <method>ANOVA</method>
            <method_desc>Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.5950</p_value>
            <method>ANOVA</method>
            <method_desc>Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.</method_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.68</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.84</ci_lower_limit>
            <ci_upper_limit>3.20</ci_upper_limit>
            <estimate_desc>Difference was calculated as Sodium fluoride (1426 ppm) minus Sodium fluoride (1150 ppm) such that a positive difference favors Sodium fluoride (1426 ppm).</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0002</p_value>
            <method>ANOVA</method>
            <method_desc>Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.</method_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>4.93</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.38</ci_lower_limit>
            <ci_upper_limit>7.48</ci_upper_limit>
            <estimate_desc>Difference was calculated as Sodium fluoride (1426 ppm) minus Sodium fluoride (250 ppm) such that a positive difference favors Sodium fluoride (1426 ppm).</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0013</p_value>
            <method>ANOVA</method>
            <method_desc>Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.</method_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>4.25</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.68</ci_lower_limit>
            <ci_upper_limit>6.82</ci_upper_limit>
            <estimate_desc>Difference was calculated as Sodium fluoride (1150 ppm) minus Sodium fluoride (250 ppm) such that a positive difference favors Sodium fluoride (1150 ppm).</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>ANOVA</method>
            <method_desc>Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.</method_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>7.71</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>5.20</ci_lower_limit>
            <ci_upper_limit>10.21</ci_upper_limit>
            <estimate_desc>Difference was calculated as Sodium fluoride (1426 ppm) minus Sodium fluoride (0 ppm) such that a positive difference favors Sodium fluoride (1426 ppm).</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>ANOVA</method>
            <method_desc>Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.</method_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>7.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>4.51</ci_lower_limit>
            <ci_upper_limit>9.55</ci_upper_limit>
            <estimate_desc>Difference was calculated as Sodium fluoride (1150 ppm) minus Sodium fluoride (0 ppm) such that a positive difference favors Sodium fluoride (1150 ppm).</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0325</p_value>
            <method>ANOVA</method>
            <method_desc>Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.</method_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>2.78</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.23</ci_lower_limit>
            <ci_upper_limit>5.32</ci_upper_limit>
            <estimate_desc>Difference was calculated as Sodium fluoride (250 ppm) minus Sodium fluoride (0 ppm) such that a positive difference favors Sodium fluoride (250 ppm).</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0920</p_value>
            <method>ANOVA</method>
            <method_desc>Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.</method_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-2.16</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.67</ci_lower_limit>
            <ci_upper_limit>0.35</ci_upper_limit>
            <estimate_desc>Difference was calculated as 'Sodium fluoride (1426 ppm) + zinc base A' minus Sodium fluoride (0 ppm) such that a positive difference favors 'Sodium fluoride (1426 ppm) + zinc base A'.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.2185</p_value>
            <method>ANOVA</method>
            <method_desc>Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.</method_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-1.56</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.04</ci_lower_limit>
            <ci_upper_limit>0.93</ci_upper_limit>
            <estimate_desc>Difference was calculated as 'Sodium fluoride (1426 ppm) + zinc base B' minus Sodium fluoride (0 ppm) such that a positive difference favors 'Sodium fluoride (1426 ppm) + zinc base B'.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>ANOVA</method>
            <method_desc>Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.</method_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>9.87</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>7.36</ci_lower_limit>
            <ci_upper_limit>12.37</ci_upper_limit>
            <estimate_desc>Difference was calculated as Sodium fluoride (1426 ppm) minus 'Sodium fluoride (1426 ppm) + zinc base A' such that a positive difference favors Sodium fluoride (1426 ppm).</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>ANOVA</method>
            <method_desc>Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.</method_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>9.26</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>6.77</ci_lower_limit>
            <ci_upper_limit>11.75</ci_upper_limit>
            <estimate_desc>Difference was calculated as Sodium fluoride (1426 ppm) minus 'Sodium fluoride (1426ppm) + zinc base B' such that a positive difference favors Sodium fluoride (1426 ppm).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Enamel Fluoride Uptake</title>
        <description>The microdrill enamel biopsy technique was used to analyze the fluoride uptake by enamel. Each enamel specimen was mounted on the long axis of a drill attached to a microdrill and drilled to a depth of approximately 100 micrometer (μm) through the entire lesion (four cores per specimen). The enamel powder pooled from four drilling sample was then immediately analyzed for fluoride content using fluoride specific electrode and pH/ion meter. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores and expressed as microgram per square centimeter (μg/cm^2).</description>
        <time_frame>Baseline to 4 hours</time_frame>
        <population>The main population for the secondary efficacy analysis was the PP population, including participants with a protocol violation affecting some (but not all) of the efficacy assessments. However, data from assessments when a violation occurred were excluded.</population>
        <group_list>
          <group group_id="O1">
            <title>Sodium Fluoride (1426 Ppm)</title>
            <description>Non-zinc, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.</description>
          </group>
          <group group_id="O2">
            <title>Sodium Fluoride (1150 Ppm)</title>
            <description>Non-zinc, 1150ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.</description>
          </group>
          <group group_id="O3">
            <title>Sodium Fluoride (250 Ppm)</title>
            <description>Non-zinc, 250ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.</description>
          </group>
          <group group_id="O4">
            <title>Sodium Fluoride (1426 Ppm) + Zinc Base A</title>
            <description>Zinc base A, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.</description>
          </group>
          <group group_id="O5">
            <title>Sodium Fluoride (1426 Ppm) + Zinc Base B</title>
            <description>Zinc base B, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.</description>
          </group>
          <group group_id="O6">
            <title>Sodium Fluoride (0 Ppm)</title>
            <description>Non-zinc, 0ppm fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.</description>
          </group>
        </group_list>
        <measure>
          <title>Enamel Fluoride Uptake</title>
          <description>The microdrill enamel biopsy technique was used to analyze the fluoride uptake by enamel. Each enamel specimen was mounted on the long axis of a drill attached to a microdrill and drilled to a depth of approximately 100 micrometer (μm) through the entire lesion (four cores per specimen). The enamel powder pooled from four drilling sample was then immediately analyzed for fluoride content using fluoride specific electrode and pH/ion meter. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores and expressed as microgram per square centimeter (μg/cm^2).</description>
          <population>The main population for the secondary efficacy analysis was the PP population, including participants with a protocol violation affecting some (but not all) of the efficacy assessments. However, data from assessments when a violation occurred were excluded.</population>
          <units>microgram per square centimeter(μg/cm^2)</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="59"/>
                <count group_id="O2" value="57"/>
                <count group_id="O3" value="55"/>
                <count group_id="O4" value="58"/>
                <count group_id="O5" value="60"/>
                <count group_id="O6" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.94" spread="0.083"/>
                    <measurement group_id="O2" value="2.70" spread="0.084"/>
                    <measurement group_id="O3" value="1.85" spread="0.085"/>
                    <measurement group_id="O4" value="2.62" spread="0.083"/>
                    <measurement group_id="O5" value="2.37" spread="0.082"/>
                    <measurement group_id="O6" value="0.98" spread="0.083"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage Net Acid Resistance (% NAR)</title>
        <description>Changes in the mineral content of the four centrally-located enamel specimens were evaluated using the SMH Test. The SMH was measured using a Wilson 2100 Hardness Tester. The baseline SMH was measured prior to the in vitro acid challenge. SMH was measured again after the in vitro acid challenge, after the in situ remineralization test, and again after the second in vitro acid challenge. The % NAR was calculated using the equation: % NAR= [(D1-D2)/(D1-B)]*100 where B= Indentation length (μm) of sound enamel at baseline; D1= Indentation length (μm) after first acid challenge and D2= Indentation length (μm) after second acid challenge.</description>
        <time_frame>Baseline to 4 hours</time_frame>
        <population>The main population for the secondary efficacy analysis was the PP population, including participants with a protocol violation affecting some (but not all) of the efficacy assessments. However, data from assessments when a violation occurred were excluded.</population>
        <group_list>
          <group group_id="O1">
            <title>Sodium Fluoride (1426 Ppm)</title>
            <description>Non-zinc, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.</description>
          </group>
          <group group_id="O2">
            <title>Sodium Fluoride (1150 Ppm)</title>
            <description>Non-zinc, 1150ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.</description>
          </group>
          <group group_id="O3">
            <title>Sodium Fluoride (250 Ppm)</title>
            <description>Non-zinc, 250ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.</description>
          </group>
          <group group_id="O4">
            <title>Sodium Fluoride (1426 Ppm) + Zinc Base A</title>
            <description>Zinc base A, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.</description>
          </group>
          <group group_id="O5">
            <title>Sodium Fluoride (1426 Ppm) + Zinc Base B</title>
            <description>Zinc base B, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.</description>
          </group>
          <group group_id="O6">
            <title>Sodium Fluoride (0 Ppm)</title>
            <description>Non-zinc, 0ppm fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage Net Acid Resistance (% NAR)</title>
          <description>Changes in the mineral content of the four centrally-located enamel specimens were evaluated using the SMH Test. The SMH was measured using a Wilson 2100 Hardness Tester. The baseline SMH was measured prior to the in vitro acid challenge. SMH was measured again after the in vitro acid challenge, after the in situ remineralization test, and again after the second in vitro acid challenge. The % NAR was calculated using the equation: % NAR= [(D1-D2)/(D1-B)]*100 where B= Indentation length (μm) of sound enamel at baseline; D1= Indentation length (μm) after first acid challenge and D2= Indentation length (μm) after second acid challenge.</description>
          <population>The main population for the secondary efficacy analysis was the PP population, including participants with a protocol violation affecting some (but not all) of the efficacy assessments. However, data from assessments when a violation occurred were excluded.</population>
          <units>Percentage of NAR</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="59"/>
                <count group_id="O2" value="57"/>
                <count group_id="O3" value="55"/>
                <count group_id="O4" value="58"/>
                <count group_id="O5" value="60"/>
                <count group_id="O6" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-12.54" spread="1.224"/>
                    <measurement group_id="O2" value="-13.45" spread="1.244"/>
                    <measurement group_id="O3" value="-17.81" spread="1.266"/>
                    <measurement group_id="O4" value="-17.60" spread="1.234"/>
                    <measurement group_id="O5" value="-18.98" spread="1.214"/>
                    <measurement group_id="O6" value="-50.60" spread="1.224"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage Comparative Acid Resistance (% CAR)</title>
        <description>Changes in the mineral content of the four centrally-located enamel specimens were evaluated using the SMH Test. The SMH was measured using a Wilson 2100 Hardness Tester. The baseline SMH was measured prior to the in vitro acid challenge. SMH was measured again after the in vitro acid challenge, after the in situ remineralization test, and again after the second in vitro acid challenge. The % CAR was calculated using the equation: % CAR= [(D2-R)/(D1-B)]*100 where B= Indentation length (μm) of sound enamel at baseline; R= Indentation length (μm) of enamel after in situ remineralization; D1= Indentation length (μm) after first acid challenge; D2= Indentation length (μm) after second acid challenge.</description>
        <time_frame>Baseline to 4 hours</time_frame>
        <population>The main population for the secondary efficacy analysis was the PP population, including participants with a protocol violation affecting some (but not all) of the efficacy assessments. However, data from assessments when a violation occurred were excluded.</population>
        <group_list>
          <group group_id="O1">
            <title>Sodium Fluoride (1426 Ppm)</title>
            <description>Non-zinc, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.</description>
          </group>
          <group group_id="O2">
            <title>Sodium Fluoride (1150 Ppm)</title>
            <description>Non-zinc, 1150ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.</description>
          </group>
          <group group_id="O3">
            <title>Sodium Fluoride (250 Ppm)</title>
            <description>Non-zinc, 250ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.</description>
          </group>
          <group group_id="O4">
            <title>Sodium Fluoride (1426 Ppm) + Zinc Base A</title>
            <description>Zinc base A, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.</description>
          </group>
          <group group_id="O5">
            <title>Sodium Fluoride (1426 Ppm) + Zinc Base B</title>
            <description>Zinc base B, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.</description>
          </group>
          <group group_id="O6">
            <title>Sodium Fluoride (0 Ppm)</title>
            <description>Sodium fluoride (0 ppm) Non-zinc, 0ppm fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage Comparative Acid Resistance (% CAR)</title>
          <description>Changes in the mineral content of the four centrally-located enamel specimens were evaluated using the SMH Test. The SMH was measured using a Wilson 2100 Hardness Tester. The baseline SMH was measured prior to the in vitro acid challenge. SMH was measured again after the in vitro acid challenge, after the in situ remineralization test, and again after the second in vitro acid challenge. The % CAR was calculated using the equation: % CAR= [(D2-R)/(D1-B)]*100 where B= Indentation length (μm) of sound enamel at baseline; R= Indentation length (μm) of enamel after in situ remineralization; D1= Indentation length (μm) after first acid challenge; D2= Indentation length (μm) after second acid challenge.</description>
          <population>The main population for the secondary efficacy analysis was the PP population, including participants with a protocol violation affecting some (but not all) of the efficacy assessments. However, data from assessments when a violation occurred were excluded.</population>
          <units>Percentage of CAR</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="59"/>
                <count group_id="O2" value="57"/>
                <count group_id="O3" value="55"/>
                <count group_id="O4" value="58"/>
                <count group_id="O5" value="60"/>
                <count group_id="O6" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.00" spread="1.274"/>
                    <measurement group_id="O2" value="45.23" spread="1.295"/>
                    <measurement group_id="O3" value="45.44" spread="1.319"/>
                    <measurement group_id="O4" value="40.29" spread="1.285"/>
                    <measurement group_id="O5" value="42.21" spread="1.264"/>
                    <measurement group_id="O6" value="75.41" spread="1.274"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Sodium Fluoride (1426 Ppm)</title>
          <description>Non-zinc, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.</description>
        </group>
        <group group_id="E2">
          <title>Sodium Fluoride (1150 Ppm)</title>
          <description>Non-zinc, 1150ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.</description>
        </group>
        <group group_id="E3">
          <title>Sodium Fluoride (250 Ppm)</title>
          <description>Non-zinc, 250ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.</description>
        </group>
        <group group_id="E4">
          <title>Sodium Fluoride (1426 Ppm) + Zinc Base A</title>
          <description>Zinc base A, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.</description>
        </group>
        <group group_id="E5">
          <title>Sodium Fluoride (1426 Ppm) + Zinc Base B</title>
          <description>Zinc base B, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.</description>
        </group>
        <group group_id="E6">
          <title>Sodium Fluoride (0 Ppm)</title>
          <description>Non-zinc, 0ppm fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.</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="59"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Adenocarcinoma of colon</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</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="3" subjects_at_risk="59"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="55"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="60"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Motion sickness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Oral Mucosal Erythema</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="59"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Abdominal Discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Parotid Gland Enlargement</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Lymph gland infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="59"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Meniscus injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Thermal burn</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Intervertebral disc degeneration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Dysmenorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>GSK Response Center</name_or_title>
      <organization>GlaxoSmithKline</organization>
      <phone>866-435-7343</phone>
    </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/NCT02195583
org study id: 202194
secondary id: RH02437
nct id: NCT02195583
lead sponsor: 
has dmc: No
This study will evaluate the effect of experimental sodium fluoride-silica dentifrice
      formulations, with and without zinc, on remineralization of enamel in situ. Following the
      remineralization phase, the acid resistance of the new mineral formed will be assessed.
      Fluoride uptake during the remineralization phase will also be measured.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Percentage Surface Microhardness Recovery (% SMHR)
time frame: Baseline to 4 hours
description: Changes in the mineral content of the four centrally-located enamel specimens were evaluated using the Surface Microhardness (SMH) Test. The SMH was measured using a Wilson 2100 Hardness Tester. The baseline SMH was determined prior to the in vitro acid challenge. SMH was determined again after the in vitro acid challenge, after the in situ remineralization test, and again after the second in vitro acid challenge. The extent of remineralization was calculated as the % recovery in SMH using the equation: % SMHR= [(D1-R)/(D1-B)]*100 Where B = indentation length (μm) of sound enamel at baseline; D1 = indentation length (μm) after first acid challenge; R = indentation length (μm) after in situ remineralization.
measure: Enamel Fluoride Uptake
time frame: Baseline to 4 hours
description: The microdrill enamel biopsy technique was used to analyze the fluoride uptake by enamel. Each enamel specimen was mounted on the long axis of a drill attached to a microdrill and drilled to a depth of approximately 100 micrometer (μm) through the entire lesion (four cores per specimen). The enamel powder pooled from four drilling sample was then immediately analyzed for fluoride content using fluoride specific electrode and pH/ion meter. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores and expressed as microgram per square centimeter (μg/cm^2).
measure: Percentage Net Acid Resistance (% NAR)
time frame: Baseline to 4 hours
description: Changes in the mineral content of the four centrally-located enamel specimens were evaluated using the SMH Test. The SMH was measured using a Wilson 2100 Hardness Tester. The baseline SMH was measured prior to the in vitro acid challenge. SMH was measured again after the in vitro acid challenge, after the in situ remineralization test, and again after the second in vitro acid challenge. The % NAR was calculated using the equation: % NAR= [(D1-D2)/(D1-B)]*100 where B= Indentation length (μm) of sound enamel at baseline; D1= Indentation length (μm) after first acid challenge and D2= Indentation length (μm) after second acid challenge.
measure: Percentage Comparative Acid Resistance (% CAR)
time frame: Baseline to 4 hours
description: Changes in the mineral content of the four centrally-located enamel specimens were evaluated using the SMH Test. The SMH was measured using a Wilson 2100 Hardness Tester. The baseline SMH was measured prior to the in vitro acid challenge. SMH was measured again after the in vitro acid challenge, after the in situ remineralization test, and again after the second in vitro acid challenge. The % CAR was calculated using the equation: % CAR= [(D2-R)/(D1-B)]*100 where B= Indentation length (μm) of sound enamel at baseline; R= Indentation length (μm) of enamel after in situ remineralization; D1= Indentation length (μm) after first acid challenge; D2= Indentation length (μm) after second acid challenge.
arm group label: Sodium fluoride (1426 ppm)
arm group type: Experimental
description: Non-zinc, 1426ppm fluoride as sodium fluoride in a silica gel base
arm group label: Sodium fluoride (1150 ppm)
arm group type: Experimental
description: Non-zinc, 1150ppm fluoride as sodium fluoride in a silica gel base
arm group label: Sodium fluoride (250 ppm)
arm group type: Experimental
description: Non-zinc, 250ppm fluoride as sodium fluoride in a silica gel base
arm group label: Sodium fluoride (1426 ppm) + zinc base A
arm group type: Experimental
description: Zinc base A, 1426ppm fluoride as sodium fluoride in a silica gel base
arm group label: Sodium fluoride (1426 ppm) + zinc base B
arm group type: Experimental
description: Zinc base B, 1426ppm fluoride as sodium fluoride in a silica gel base
arm group label: Fluoride (0 ppm)
arm group type: Placebo Comparator
description: Non-zinc, 0ppm fluoride in a silica gel base
intervention type: Drug
intervention name: Sodium fluoride (1426 ppm)
description: Non-zinc, 1426ppm fluoride as sodium fluoride in a silica gel base
arm group label: Sodium fluoride (1426 ppm)
intervention type: Drug
intervention name: Sodium fluoride (1150 ppm)
description: Non-zinc, 1150ppm fluoride as sodium fluoride in a silica gel base
arm group label: Sodium fluoride (1150 ppm)
intervention type: Drug
intervention name: Sodium fluoride (250 ppm)
description: Non-zinc, 250ppm fluoride as sodium fluoride in a silica gel base
arm group label: Sodium fluoride (250 ppm)
intervention type: Drug
intervention name: Sodium fluoride (1426 ppm) + zinc base A
description: Zinc base A, 1426ppm fluoride as sodium fluoride in a silica gel base
arm group label: Sodium fluoride (1426 ppm) + zinc base A
intervention type: Drug
intervention name: Sodium fluoride (1426 ppm) + zinc base B
description: Zinc base B, 1426ppm fluoride as sodium fluoride in a silica gel base
arm group label: Sodium fluoride (1426 ppm) + zinc base B
intervention type: Drug
intervention name: Fluoride (0 ppm)
description: Non-zinc, 0ppm fluoride in a silica gel base
arm group label: Fluoride (0 ppm)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
facility: 
country: United States
responsible party type: Sponsor
mesh term: Zinc
mesh term: Listerine
mesh term: Fluorides
mesh term: Sodium Fluoride
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 