<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/NCT01727258</url>
  </required_header>
  <id_info>
    <org_study_id>KOXDHY0008</org_study_id>
    <nct_id>NCT01727258</nct_id>
  </id_info>
  <brief_title>A Test on a New Experimental Mouth Rinse for Relieving Tooth Sensitivity</brief_title>
  <official_title>Evaluation of an Experimental Mouth Rinse Device for Relieving Dentinal Hypersensitivity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johnson &amp; Johnson Consumer and Personal Products Worldwide</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johnson &amp; Johnson Consumer and Personal Products Worldwide</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is for people with sensitive teeth and involves going to the dentist for 4 visits&#xD;
      over 6 weeks. At each visit the dentist will look at the mouth, teeth, tongue and gums of&#xD;
      subjects, and check for sensitive teeth.&#xD;
&#xD;
      During the first 2 weeks, participants will brush their teeth two times a day with the&#xD;
      fluoride toothpaste provided.&#xD;
&#xD;
      Then, if they qualify to continue in the study, participants will be assigned to a treatment&#xD;
      group. All the groups will get toothpaste currently sold on the market, and one group will&#xD;
      get a mouthwash with an experimental ingredient to use as well. Subjects will have an equal&#xD;
      chance of being assigned to any one of the three groups.&#xD;
&#xD;
      For the next 4 weeks, subjects will use their assigned products according to the directions&#xD;
      provided. At Visit 1 subjects will be supervised while they brush their teeth to ensure they&#xD;
      understand the directions. They will also have supervised use of the product at Visit 2.&#xD;
&#xD;
      We will see if the mouthwash helps to reduce tooth sensitivity during the study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will consist of run-in and treatment phases. To qualify for the study, subjects&#xD;
      must meet the inclusion/exclusion criteria and return tactile sensitivity scores within&#xD;
      protocol-specified parameters at both the screening and baseline visits.&#xD;
&#xD;
      Run-in will consist of a 2-week period during which subjects will use a sodium fluoride&#xD;
      dentifrice. At the start of the first phase, subjects will attend a Screening Visit. They&#xD;
      will participate in the informed consent process, complete a medical/dental history, and be&#xD;
      evaluated for tactile sensitivity to Yeaple probe and response to a cold air stimulus.&#xD;
&#xD;
      Subjects who qualify through screening will begin a run-in period that will last&#xD;
      approximately two weeks. The run-in period will be followed by a Baseline visit. Subjects who&#xD;
      continue to qualify through Baseline will be randomized to one of three treatment groups.&#xD;
&#xD;
      During the four-week treatment period, all subjects will brush their teeth twice daily for at&#xD;
      least one minute in their usual manner, with their assigned toothpaste. After brushing,&#xD;
      subjects assigned to the mouth rinse group will rinse with water, and then rinse with 10 mL&#xD;
      of the experimental mouth rinse for 60 seconds.&#xD;
&#xD;
      The study duration is approximately six weeks with each subject visiting the clinical site&#xD;
      six times.&#xD;
&#xD;
      Adverse events will be observed and collected by querying each subject at each visit for new&#xD;
      or continuing symptoms.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">February 2013</completion_date>
  <primary_completion_date type="Actual">February 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>Parallel Assignment</intervention_model>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Tactile Sensitivity Score at Week 4</measure>
    <time_frame>4 weeks</time_frame>
    <description>Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Tactile Sensitivity Score at Week 2</measure>
    <time_frame>2 weeks</time_frame>
    <description>Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Tactile Sensitivity VAS Score at Week 2</measure>
    <time_frame>2 weeks</time_frame>
    <description>Tooth sensitivity was measured using a Visual Analogue Scale (VAS). At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Tactile Sensitivity VAS Score at Week 4</measure>
    <time_frame>4 weeks</time_frame>
    <description>Tooth sensitivity was measured using a Visual Analogue Scale (VAS). At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Cold Air Stimulus VAS Score at Week 2</measure>
    <time_frame>2 weeks</time_frame>
    <description>Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Cold Air Stimulus VAS Score at Week 4</measure>
    <time_frame>4 weeks</time_frame>
    <description>Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">153</enrollment>
  <condition>Dentin Sensitivity</condition>
  <arm_group>
    <arm_group_label>Mouth Rinse</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Twice daily for 28 days, brush in usual manner for at least one minute using at least a one-inch strip of Fluoride Toothpaste provided. Rinse with water after brushing teeth. Then rinse for 60 seconds with 10 mL of the experimental Mouth Rinse 12027-033 (KOX).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fluoride Toothpaste</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Twice daily for 28 days, brush in usual manner for at least one minute using at least a one-inch strip of the Fluoride Toothpaste (NEG) provided.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Potassium Nitrate Toothpaste</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Twice daily for 28 days, brush in usual manner for at least one minute using at least a one-inch strip of the Potassium Nitrate Toothpaste (POS) provided.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Mouth Rinse</intervention_name>
    <description>Mouth rinse 12027-033 used twice daily for 28 days after brushing.</description>
    <arm_group_label>Mouth Rinse</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fluoride Toothpaste</intervention_name>
    <description>Fluoride Toothpaste used daily for 28 days.</description>
    <arm_group_label>Fluoride Toothpaste</arm_group_label>
    <arm_group_label>Mouth Rinse</arm_group_label>
    <other_name>Colgate® Cavity Protection Regular</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Potassium Nitrate Toothpaste</intervention_name>
    <description>Potassium Nitrate Toothpaste used daily for 28 days.</description>
    <arm_group_label>Potassium Nitrate Toothpaste</arm_group_label>
    <other_name>Sensodyne® Original</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Good general and oral health without any known allergy to commercial dental products&#xD;
             or cosmetics&#xD;
&#xD;
          -  Evidence of a personally signed and dated informed consent document indicating the&#xD;
             subject (or legally acceptable representative) has been informed of all pertinent&#xD;
             aspects of the trial&#xD;
&#xD;
          -  Willingness to use the assigned products according to instructions, availability for&#xD;
             appointments, and likelihood of completing the clinical trial&#xD;
&#xD;
          -  Dental condition appropriate for inclusion in the trial according to&#xD;
             protocol-specified parameters and the professional opinion of the investigator&#xD;
&#xD;
          -  Adequate oral hygiene (i.e. brush teeth daily and exhibit no signs of oral neglect&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medical condition or history, or use of drugs or treatments that could possibly&#xD;
             compromise the safety of the research subject or the interpretation of results, per&#xD;
             protocol or in the opinion of the investigator&#xD;
&#xD;
          -  Use of home-care bleaching, whitening products or professional bleaching treatment&#xD;
             within a protocol-specified time period&#xD;
&#xD;
          -  Use of desensitizing agents within a protocol-specified time period&#xD;
&#xD;
          -  Participation in a dental clinical trial involving oral care products within a&#xD;
             protocol-specified time period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Lynch, DMD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Johnson &amp; Johnson Consumer and Personal Products Worldwide</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>BioSci Research America, Inc.</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>November 12, 2012</study_first_submitted>
  <study_first_submitted_qc>November 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 15, 2012</study_first_posted>
  <results_first_submitted>May 20, 2015</results_first_submitted>
  <results_first_submitted_qc>June 8, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">June 10, 2015</results_first_posted>
  <last_update_submitted>June 8, 2015</last_update_submitted>
  <last_update_submitted_qc>June 8, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 10, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Tooth Sensitivity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dentin Sensitivity</mesh_term>
    <mesh_term>Hypersensitivity</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fluorides</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Colgate Regular</title>
          <description>Standard Sodium Fluoride Dentifrice (Negative Control) (UPC #035000513007).</description>
        </group>
        <group group_id="P2">
          <title>Sensodyne Toothpaste</title>
          <description>5% Potassium Nitrate Dentifrice (Positive Control) (UPC #310158077046).</description>
        </group>
        <group group_id="P3">
          <title>Potassium Oxalate Mouthrinse</title>
          <description>Potassium Oxalate Mouthrinse (experimental group)(12027-033).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="51"/>
                <participants group_id="P2" count="51"/>
                <participants group_id="P3" count="51"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="49"/>
                <participants group_id="P2" count="48"/>
                <participants group_id="P3" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Noncompliance with Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Colgate Regular</title>
          <description>Standard Sodium Fluoride Dentifrice (Negative Control) (UPC #035000513007).</description>
        </group>
        <group group_id="B2">
          <title>Sensodyne Toothpaste</title>
          <description>5% Potassium Nitrate Dentifrice (Positive Control) (UPC #310158077046).</description>
        </group>
        <group group_id="B3">
          <title>Potassium Oxalate Mouthrinse</title>
          <description>Potassium Oxalate Mouthrinse (experimental group)(12027-033).</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="51"/>
            <count group_id="B2" value="51"/>
            <count group_id="B3" value="51"/>
            <count group_id="B4" value="153"/>
          </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="38.4" spread="10.97"/>
                    <measurement group_id="B2" value="37.0" spread="11.56"/>
                    <measurement group_id="B3" value="39.9" spread="10.46"/>
                    <measurement group_id="B4" value="38.4" spread="11.00"/>
                  </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="33"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="39"/>
                    <measurement group_id="B4" value="109"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="44"/>
                  </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>USA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                    <measurement group_id="B2" value="51"/>
                    <measurement group_id="B3" value="51"/>
                    <measurement group_id="B4" value="153"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mean Tactile Sensitivity Score at Week 4</title>
        <description>Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.</description>
        <time_frame>4 weeks</time_frame>
        <population>Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Colgate Regular</title>
            <description>Standard Sodium Fluoride Dentifrice (Negative Control) (UPC #035000513007)</description>
          </group>
          <group group_id="O2">
            <title>Sensodyne Toothpaste</title>
            <description>5% Potassium Nitrate Dentifrice (Positive Control) (UPC #310158077046)</description>
          </group>
          <group group_id="O3">
            <title>Potassium Oxalate Mouthrinse</title>
            <description>Potassium Oxalate Mouthrinse (experimental group)(12027-033)</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Tactile Sensitivity Score at Week 4</title>
          <description>Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.</description>
          <population>Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.</population>
          <units>grams of force</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="49"/>
                <count group_id="O2" value="48"/>
                <count group_id="O3" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.21" spread="1.221"/>
                    <measurement group_id="O2" value="23.81" spread="1.234"/>
                    <measurement group_id="O3" value="22.07" spread="1.210"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>If Potassium Oxalate Mouthrinse is better than Colgate Regular (p&lt;0.05), testing would proceed to comparison of Wk 2 Mean Tactile Sensitivity Scores between Potassium Oxalate Mouthrinse and Colgate Regular. Family-wise error was controlled at 0.05.</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>10.85</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.720</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>7.45</ci_lower_limit>
            <ci_upper_limit>14.25</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.314</p_value>
            <p_value_desc>The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.74</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.729</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.16</ci_lower_limit>
            <ci_upper_limit>1.67</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>12.60</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.735</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>9.17</ci_lower_limit>
            <ci_upper_limit>16.03</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Tactile Sensitivity Score at Week 2</title>
        <description>Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.</description>
        <time_frame>2 weeks</time_frame>
        <population>Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Colgate Regular</title>
            <description>Standard Sodium Fluoride Dentifrice (Negative Control) (UPC #035000513007)</description>
          </group>
          <group group_id="O2">
            <title>Sensodyne Toothpaste</title>
            <description>5% Potassium Nitrate Dentifrice (Positive Control) (UPC #310158077046)</description>
          </group>
          <group group_id="O3">
            <title>Potassium Oxalate Mouthrinse</title>
            <description>Potassium Oxalate Mouthrinse (experimental group)(12027-033)</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Tactile Sensitivity Score at Week 2</title>
          <description>Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.</description>
          <population>Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.</population>
          <units>grams of force</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="50"/>
                <count group_id="O2" value="49"/>
                <count group_id="O3" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.09" spread="0.832"/>
                    <measurement group_id="O2" value="17.00" spread="0.840"/>
                    <measurement group_id="O3" value="17.18" spread="0.832"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>If Potassium Oxalate Mouthrinse is better than Colgate Regular (p&lt;0.05), testing would proceed to comparison of Wk 2 Mean Tactile Sensitivity Scores between Potassium Oxalate Mouthrinse and Sensodyne. Family-wise error was controlled at 0.05.</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>6.08</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.177</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>3.76</ci_lower_limit>
            <ci_upper_limit>8.41</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.881</p_value>
            <p_value_desc>The significance threshold level was 0.05 (two-sided). Family-wise error was controlled at 0.05.</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.18</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.183</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.16</ci_lower_limit>
            <ci_upper_limit>2.52</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>5.91</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.182</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>3.57</ci_lower_limit>
            <ci_upper_limit>8.24</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Tactile Sensitivity VAS Score at Week 2</title>
        <description>Tooth sensitivity was measured using a Visual Analogue Scale (VAS). At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.</description>
        <time_frame>2 weeks</time_frame>
        <population>Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Colgate Regular</title>
            <description>Standard Sodium Fluoride Dentifrice (Negative Control) (UPC #035000513007)</description>
          </group>
          <group group_id="O2">
            <title>Sensodyne Toothpaste</title>
            <description>5% Potassium Nitrate Dentifrice (Positive Control) (UPC #310158077046)</description>
          </group>
          <group group_id="O3">
            <title>Potassium Oxalate Mouthrinse</title>
            <description>Potassium Oxalate Mouthrinse (experimental group)(12027-033)</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Tactile Sensitivity VAS Score at Week 2</title>
          <description>Tooth sensitivity was measured using a Visual Analogue Scale (VAS). At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.</description>
          <population>Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.</population>
          <units>units on a scale (mm)</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="50"/>
                <count group_id="O2" value="49"/>
                <count group_id="O3" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.80" spread="2.009"/>
                    <measurement group_id="O2" value="36.95" spread="2.020"/>
                    <measurement group_id="O3" value="37.08" spread="2.017"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.020</p_value>
            <p_value_desc>The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>Terms included treatment and baseline mean tactile sensitivity VAS score.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-6.72</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.866</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-12.38</ci_lower_limit>
            <ci_upper_limit>-1.05</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.964</p_value>
            <p_value_desc>The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>Terms included treatment and baseline mean tactile sensitivity VAS score.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.13</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.860</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.52</ci_lower_limit>
            <ci_upper_limit>5.78</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.017</p_value>
            <p_value_desc>The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>Terms included treatment and baseline mean tactile sensitivity VAS score.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-6.85</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.845</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-12.47</ci_lower_limit>
            <ci_upper_limit>-1.23</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Tactile Sensitivity VAS Score at Week 4</title>
        <description>Tooth sensitivity was measured using a Visual Analogue Scale (VAS). At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.</description>
        <time_frame>4 weeks</time_frame>
        <population>Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Colgate Regular</title>
            <description>Standard Sodium Fluoride Dentifrice (Negative Control) (UPC #035000513007)</description>
          </group>
          <group group_id="O2">
            <title>Sensodyne Toothpaste</title>
            <description>5% Potassium Nitrate Dentifrice (Positive Control) (UPC #310158077046)</description>
          </group>
          <group group_id="O3">
            <title>Potassium Oxalate Mouthrinse</title>
            <description>Potassium Oxalate Mouthrinse (experimental group)(12027-033)</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Tactile Sensitivity VAS Score at Week 4</title>
          <description>Tooth sensitivity was measured using a Visual Analogue Scale (VAS). At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.</description>
          <population>Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.</population>
          <units>units on a scale (mm)</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="49"/>
                <count group_id="O2" value="48"/>
                <count group_id="O3" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.38" spread="2.342"/>
                    <measurement group_id="O2" value="26.40" spread="2.353"/>
                    <measurement group_id="O3" value="31.45" spread="2.327"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.039</p_value>
            <p_value_desc>The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>Terms included treatment and baseline mean tactile sensitivity VAS score.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-6.92</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.327</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-13.50</ci_lower_limit>
            <ci_upper_limit>-0.35</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.130</p_value>
            <p_value_desc>The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>Terms included treatment and baseline mean tactile sensitivity VAS score.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>5.06</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.317</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.50</ci_lower_limit>
            <ci_upper_limit>11.61</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>Terms included treatment and baseline mean tactile sensitivity VAS score.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-11.98</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.313</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-18.53</ci_lower_limit>
            <ci_upper_limit>-5.43</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Cold Air Stimulus VAS Score at Week 2</title>
        <description>Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant.</description>
        <time_frame>2 weeks</time_frame>
        <population>Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Colgate Regular</title>
            <description>Standard Sodium Fluoride Dentifrice (Negative Control) (UPC #035000513007)</description>
          </group>
          <group group_id="O2">
            <title>Sensodyne Toothpaste</title>
            <description>5% Potassium Nitrate Dentifrice (Positive Control) (UPC #310158077046)</description>
          </group>
          <group group_id="O3">
            <title>Potassium Oxalate Mouthrinse</title>
            <description>Potassium Oxalate Mouthrinse (experimental group)(12027-033)</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Cold Air Stimulus VAS Score at Week 2</title>
          <description>Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant.</description>
          <population>Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.</population>
          <units>units on a scale (mm)</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="50"/>
                <count group_id="O2" value="49"/>
                <count group_id="O3" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.41" spread="2.233"/>
                    <measurement group_id="O2" value="32.89" spread="2.246"/>
                    <measurement group_id="O3" value="37.15" spread="2.227"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.010</p_value>
            <p_value_desc>The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>Terms included treatment and baseline mean air stimulus VAS score.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-8.26</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.163</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-14.51</ci_lower_limit>
            <ci_upper_limit>-2.00</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.179</p_value>
            <p_value_desc>The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>Terms included treatment and baseline mean air stimulus VAS score.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>4.26</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.160</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.98</ci_lower_limit>
            <ci_upper_limit>10.51</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>Terms included treatment and baseline mean air stimulus VAS score.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-12.52</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.172</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-18.79</ci_lower_limit>
            <ci_upper_limit>-6.25</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Cold Air Stimulus VAS Score at Week 4</title>
        <description>Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant.</description>
        <time_frame>4 weeks</time_frame>
        <population>Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Colgate Regular</title>
            <description>Standard Sodium Fluoride Dentifrice (Negative Control) (UPC #035000513007)</description>
          </group>
          <group group_id="O2">
            <title>Sensodyne Toothpaste</title>
            <description>5% Potassium Nitrate Dentifrice (Positive Control) (UPC #310158077046)</description>
          </group>
          <group group_id="O3">
            <title>Potassium Oxalate Mouthrinse</title>
            <description>Potassium Oxalate Mouthrinse (experimental group)(12027-033)</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Cold Air Stimulus VAS Score at Week 4</title>
          <description>Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant.</description>
          <population>Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.</population>
          <units>units on a scale (mm)</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="49"/>
                <count group_id="O2" value="48"/>
                <count group_id="O3" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.03" spread="2.511"/>
                    <measurement group_id="O2" value="24.56" spread="2.524"/>
                    <measurement group_id="O3" value="30.10" spread="2.479"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>Terms included treatment and baseline mean air stimulus VAS score.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-11.93</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.543</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-18.93</ci_lower_limit>
            <ci_upper_limit>-4.93</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.119</p_value>
            <p_value_desc>The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>Terms included treatment and baseline mean air stimulus VAS score.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>5.54</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.534</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.44</ci_lower_limit>
            <ci_upper_limit>12.53</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>Terms included treatment and baseline mean air stimulus VAS score.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-17.47</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.566</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-24.52</ci_lower_limit>
            <ci_upper_limit>-10.42</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Day 28 -2 days/+4 days, +30 days for serious adverse events.</time_frame>
      <desc>Adverse events were systematically collected at each study visit through Visit 4 (Day 28 -2 days/+4 days). Serious adverse events were reported through 30 days after product use. Spontaneously reported adverse events collected outside of the regularly scheduled visits were also recorded.</desc>
      <group_list>
        <group group_id="E1">
          <title>Colgate Regular</title>
          <description>Standard Sodium Fluoride Dentifrice (Negative Control) (UPC #035000513007).</description>
        </group>
        <group group_id="E2">
          <title>Sensodyne Toothpaste</title>
          <description>5% Potassium Nitrate Dentifrice (Positive Control) (UPC #310158077046).</description>
        </group>
        <group group_id="E3">
          <title>Potassium Oxalate Mouthrinse</title>
          <description>Potassium Oxalate Mouthrinse (experimental group)(12027-033).</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="51"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
              </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="51"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
              </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>Principal investigator agreed not to publish the study results without prior sponsor approval.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Michael Lynch, DMD, PhD/Study Director</name_or_title>
      <organization>Johnson &amp; Johnson Consumer and Personal Products Worldwide</organization>
      <phone>908-433-6423 USA EST</phone>
      <email>mlynch23@its.jnj.com</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/NCT01727258
org study id: KOXDHY0008
nct id: NCT01727258
lead sponsor: 
has dmc: No
This study is for people with sensitive teeth and involves going to the dentist for 4 visits
      over 6 weeks. At each visit the dentist will look at the mouth, teeth, tongue and gums of
      subjects, and check for sensitive teeth.

      During the first 2 weeks, participants will brush their teeth two times a day with the
      fluoride toothpaste provided.

      Then, if they qualify to continue in the study, participants will be assigned to a treatment
      group. All the groups will get toothpaste currently sold on the market, and one group will
      get a mouthwash with an experimental ingredient to use as well. Subjects will have an equal
      chance of being assigned to any one of the three groups.

      For the next 4 weeks, subjects will use their assigned products according to the directions
      provided. At Visit 1 subjects will be supervised while they brush their teeth to ensure they
      understand the directions. They will also have supervised use of the product at Visit 2.

      We will see if the mouthwash helps to reduce tooth sensitivity during the study.
This study will consist of run-in and treatment phases. To qualify for the study, subjects
      must meet the inclusion/exclusion criteria and return tactile sensitivity scores within
      protocol-specified parameters at both the screening and baseline visits.

      Run-in will consist of a 2-week period during which subjects will use a sodium fluoride
      dentifrice. At the start of the first phase, subjects will attend a Screening Visit. They
      will participate in the informed consent process, complete a medical/dental history, and be
      evaluated for tactile sensitivity to Yeaple probe and response to a cold air stimulus.

      Subjects who qualify through screening will begin a run-in period that will last
      approximately two weeks. The run-in period will be followed by a Baseline visit. Subjects who
      continue to qualify through Baseline will be randomized to one of three treatment groups.

      During the four-week treatment period, all subjects will brush their teeth twice daily for at
      least one minute in their usual manner, with their assigned toothpaste. After brushing,
      subjects assigned to the mouth rinse group will rinse with water, and then rinse with 10 mL
      of the experimental mouth rinse for 60 seconds.

      The study duration is approximately six weeks with each subject visiting the clinical site
      six times.

      Adverse events will be observed and collected by querying each subject at each visit for new
      or continuing symptoms.
allocation: Randomized
intervention model: Parallel Assignment
masking: Single (Investigator)
measure: Mean Tactile Sensitivity Score at Week 4
time frame: 4 weeks
description: Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.
measure: Mean Tactile Sensitivity Score at Week 2
time frame: 2 weeks
description: Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.
measure: Mean Tactile Sensitivity VAS Score at Week 2
time frame: 2 weeks
description: Tooth sensitivity was measured using a Visual Analogue Scale (VAS). At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.
measure: Mean Tactile Sensitivity VAS Score at Week 4
time frame: 4 weeks
description: Tooth sensitivity was measured using a Visual Analogue Scale (VAS). At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.
measure: Mean Cold Air Stimulus VAS Score at Week 2
time frame: 2 weeks
description: Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant.
measure: Mean Cold Air Stimulus VAS Score at Week 4
time frame: 4 weeks
description: Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant.
arm group label: Mouth Rinse
arm group type: Experimental
description: Twice daily for 28 days, brush in usual manner for at least one minute using at least a one-inch strip of Fluoride Toothpaste provided. Rinse with water after brushing teeth. Then rinse for 60 seconds with 10 mL of the experimental Mouth Rinse 12027-033 (KOX).
arm group label: Fluoride Toothpaste
arm group type: Active Comparator
description: Twice daily for 28 days, brush in usual manner for at least one minute using at least a one-inch strip of the Fluoride Toothpaste (NEG) provided.
arm group label: Potassium Nitrate Toothpaste
arm group type: Active Comparator
description: Twice daily for 28 days, brush in usual manner for at least one minute using at least a one-inch strip of the Potassium Nitrate Toothpaste (POS) provided.
intervention type: Device
intervention name: Mouth Rinse
description: Mouth rinse 12027-033 used twice daily for 28 days after brushing.
arm group label: Mouth Rinse
intervention type: Drug
intervention name: Fluoride Toothpaste
description: Fluoride Toothpaste used daily for 28 days.
arm group label: Fluoride Toothpaste
arm group label: Mouth Rinse
other name: Colgate® Cavity Protection Regular
intervention type: Drug
intervention name: Potassium Nitrate Toothpaste
description: Potassium Nitrate Toothpaste used daily for 28 days.
arm group label: Potassium Nitrate Toothpaste
other name: Sensodyne® Original
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michael Lynch, DMD, PhD
role: Study Director
affiliation: Johnson & Johnson Consumer and Personal Products Worldwide
facility: 
country: United States
responsible party type: Sponsor
mesh term: Dentin Sensitivity
mesh term: Hypersensitivity
mesh term: Fluorides
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 