<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/NCT01691560</url>
  </required_header>
  <id_info>
    <org_study_id>RH01426</org_study_id>
    <nct_id>NCT01691560</nct_id>
  </id_info>
  <brief_title>Exploratory Study to Evaluate an Occlusion Based Dentifrice in Relief of Dentinal Hypersensitivity</brief_title>
  <official_title>A Proof of Concept Study to Evaluate the Efficacy of an Occlusion Based Dentifrice in the Relief of Dentinal Hypersensitivity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>BioSci Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this exploratory study is to compare the treatment effect on dentinal&#xD;
      hypersensitivity of a tubule occluding dentifrice as measured by Schiff and Tactile&#xD;
      sensitivity. This proof of concept study will compare the test dentifrice with three other&#xD;
      treatment groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This will be a single center, eight week, randomized, controlled, examiner blind, four&#xD;
      treatment arm, parallel design, stratified (by maximum baseline Schiff Sensitivity Score of&#xD;
      the two selected test teeth), exploratory study in participants with at least two sensitive&#xD;
      teeth that meet all the criteria at the Screening and Baseline visit. Participants will be&#xD;
      assessed at Baseline, four and eight weeks to monitor clinical efficacy and safety.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">November 2012</completion_date>
  <primary_completion_date type="Actual">November 2012</primary_completion_date>
  <phase>Phase 2</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Evaporative Air Sensitivity Pain Response on Schiff Sensitivity Scale at Week 4</measure>
    <time_frame>Baseline to 4 weeks post administration of study treatment</time_frame>
    <description>Response to a constant jet of air applied to hypersensitive teeth was evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant does not respond to air stimulation, 1 - participant responds to air stimulus but does not request discontinuation of stimulus, 2 - participant responds to air stimulus and request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Tactile Sensitivity Pain Response (g) at Week 4</measure>
    <time_frame>Baseline to 4 weeks post administration of study treatment</time_frame>
    <description>Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. In tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response was recorded or the maximum force was reached.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Evaporative Air Sensitivity Pain Response on Schiff Sensitivity Scale at Week 8</measure>
    <time_frame>Baseline to 8 weeks post administration of study treatment</time_frame>
    <description>Response to a constant jet of air applied to hypersensitive teeth was evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant does not respond to air stimulation, 1 - participant responds to air stimulus but does not request discontinuation of stimulus, 2 - participant responds to air stimulus and request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Tactile Sensitivity Pain Response (g) at Week 8</measure>
    <time_frame>Baseline to 8 weeks post administration of study treatment</time_frame>
    <description>Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. In tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response was recorded or the maximum force was reached.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Evaporative Air Sensitivity Response on a Visual Rating Scale (VRS) at Week 4</measure>
    <time_frame>Baseline to 4 weeks post administration of study treatment</time_frame>
    <description>Participants rated the intensity of their response to the stimulus using a 10 point Visual rating scale of 1 (no Pain) to 10 (intense pain).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Evaporative Air Sensitivity Response on VRS at Week 8</measure>
    <time_frame>Baseline to 8 weeks post administration of study treatment</time_frame>
    <description>Participants rated the intensity of their response to the stimulus using a 10 point VRS of 1 (no Pain) to 10 (intense pain).</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">140</enrollment>
  <condition>Dentine Hypersensitivity</condition>
  <arm_group>
    <arm_group_label>5% calcium sodium phosphosilicate/sodium monofluorophosphate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dentifrice containing 5.0% w/w calcium sodium phosphosilicate with sodium monofluorophosphate containing 1500 parts per million fluoride (ppmF).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>0% calcium sodium phosphosilicate/sodium monofluorophosphate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppmF as sodium monofluorophosphate</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sodium monofluorophosphate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Dentifrice containing 1000 ppmF as sodium monofluorophosphate</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sodium fluoride</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Dentifrice containing 1100 ppmF as sodium fluoride</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>5% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice</intervention_name>
    <description>Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppmF as sodium monofluorophosphate</description>
    <arm_group_label>5% calcium sodium phosphosilicate/sodium monofluorophosphate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>0% calcium sodium phosphosilicate/sodium monofluorophosphate dentifrice</intervention_name>
    <description>Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppmF as sodium monofluorophosphate</description>
    <arm_group_label>0% calcium sodium phosphosilicate/sodium monofluorophosphate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sodium monofluorophosphate dentifrice</intervention_name>
    <description>Dentifrice containing 1000 ppmF as sodium monofluorophosphate</description>
    <arm_group_label>Sodium monofluorophosphate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sodium fluoride dentifrice</intervention_name>
    <description>Dentifrice containing 1100 ppmF as sodium fluoride</description>
    <arm_group_label>Sodium fluoride</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Participants between 18 and 55 years of age, in good general health, with pre-existing&#xD;
             self-reported and clinically diagnosed tooth sensitivity are required for entry into&#xD;
             the study&#xD;
&#xD;
          2. Participants will be required to have at least four teeth with facial/cervical&#xD;
             erosion, abrasion and/or gingival recession which respond to qualifying evaporative&#xD;
             (air) assessment at the Screening visit and have at least two teeth (incisors, canines&#xD;
             or pre-molars) demonstrating signs of sensitivity, measured by qualifying tactile&#xD;
             threshold (Yeaple ≤ 20 gram (g)) and evaporative (air) (Schiff Sensitivity Score ≥ 2)&#xD;
             assessments at the Baseline visit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnancy: Women who are known to be pregnant or who are intending to become pregnant&#xD;
             over the duration of the study.&#xD;
&#xD;
          2. Breast-feeding: Women who are breast-feeding.&#xD;
&#xD;
          3. Medical History: a) Chronic debilitating disease is present b) Chronic disease or&#xD;
             other condition is present that is associated with intermittent episodes or constant&#xD;
             daily pain, such as arthritis, low back pain, dysmenorrhea, etc.&#xD;
&#xD;
          4. Medications: Daily doses of medication, which in the opinion of the investigator,&#xD;
             might interfere with the perception of pain, are being taken. Examples of such&#xD;
             medications include analgesics, anticonvulsants, antihistamines that cause marked or&#xD;
             moderate sedation, sedatives, tranquilizers, mood-altering and anti-inflammatory&#xD;
             drugs.&#xD;
&#xD;
          5. Dentition Exclusions: a) Sensitive teeth not expected to respond to treatment with an&#xD;
             over-the- counter dentifrice in the opinion of the investigator. b) Teeth with exposed&#xD;
             dentine but with deep, defective or facial restorations, teeth used as abutments for&#xD;
             fixed or removable partial dentures, teeth with full crowns, orthodontic bands,&#xD;
             extensive caries or cracked enamel. Sensitive teeth with contributing etiologies other&#xD;
             than erosion, abrasion or recession of exposed dentine. c) Dental professional hygiene&#xD;
             (includes dental prophylaxis, irrigation, and intensive anti-microbial/anti-biotic&#xD;
             therapy) within 14 days of the screening visit. d) Presence of dental implants. e) Lip&#xD;
             or tongue piercings. f) Periodontal surgical history within the past 6 months or have&#xD;
             been scaled /root planed within the past 3 months.&#xD;
&#xD;
          6. Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the study&#xD;
             materials (or closely related compounds) or any of their stated ingredients.&#xD;
&#xD;
          7. Clinical Study/Experimental Medication: a) Participation in another clinical study or&#xD;
             receipt of an investigational drug within 30 days of the screening visit b) Previous&#xD;
             participation in this study.&#xD;
&#xD;
          8. Other: Any subject who in the opinion of the investigator, should not participate in&#xD;
             the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>BioSci Research America</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89121-5466</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2013</verification_date>
  <study_first_submitted>September 20, 2012</study_first_submitted>
  <study_first_submitted_qc>September 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 24, 2012</study_first_posted>
  <results_first_submitted>May 1, 2014</results_first_submitted>
  <results_first_submitted_qc>May 1, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">May 29, 2014</results_first_posted>
  <last_update_submitted>May 1, 2014</last_update_submitted>
  <last_update_submitted_qc>May 1, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 29, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>Calcium, Dietary</mesh_term>
    <mesh_term>Listerine</mesh_term>
    <mesh_term>Calcium</mesh_term>
    <mesh_term>Fluorides</mesh_term>
    <mesh_term>Sodium Fluoride</mesh_term>
    <mesh_term>Fluorophosphate</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were recruited at the clinical site.</recruitment_details>
      <pre_assignment_details>Out of 152 screened participants, 16 did not meet the study criterion while 2 withdrew consent. Hence, a total of 134 participants were randomized into the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate</title>
          <description>Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500 parts per million (ppm) fluoride as sodium monofluorophosphate</description>
        </group>
        <group group_id="P2">
          <title>0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate</title>
          <description>Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate</description>
        </group>
        <group group_id="P3">
          <title>Sodium Monofluorophosphate</title>
          <description>Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate</description>
        </group>
        <group group_id="P4">
          <title>Sodium Fluoride</title>
          <description>Dentifrice containing 1100 ppm fluoride as sodium fluoride</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
                <participants group_id="P2" count="33"/>
                <participants group_id="P3" count="34"/>
                <participants group_id="P4" count="33"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
                <participants group_id="P2" count="33"/>
                <participants group_id="P3" count="34"/>
                <participants group_id="P4" count="33"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate</title>
          <description>Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate</description>
        </group>
        <group group_id="B2">
          <title>0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate</title>
          <description>Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate</description>
        </group>
        <group group_id="B3">
          <title>Sodium Monofluorophosphate</title>
          <description>Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate</description>
        </group>
        <group group_id="B4">
          <title>Sodium Fluoride</title>
          <description>Dentifrice containing 1100 ppm fluoride as sodium fluoride</description>
        </group>
        <group group_id="B5">
          <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="34"/>
            <count group_id="B2" value="33"/>
            <count group_id="B3" value="34"/>
            <count group_id="B4" value="33"/>
            <count group_id="B5" value="134"/>
          </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="35.4" spread="10.45"/>
                    <measurement group_id="B2" value="33.2" spread="10.13"/>
                    <measurement group_id="B3" value="38.2" spread="8.88"/>
                    <measurement group_id="B4" value="36.2" spread="9.62"/>
                    <measurement group_id="B5" value="35.8" spread="9.85"/>
                  </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="25"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="27"/>
                    <measurement group_id="B4" value="22"/>
                    <measurement group_id="B5" value="98"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="11"/>
                    <measurement group_id="B5" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Evaporative Air Sensitivity Pain Response on Schiff Sensitivity Scale at Week 4</title>
        <description>Response to a constant jet of air applied to hypersensitive teeth was evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant does not respond to air stimulation, 1 - participant responds to air stimulus but does not request discontinuation of stimulus, 2 - participant responds to air stimulus and request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus.</description>
        <time_frame>Baseline to 4 weeks post administration of study treatment</time_frame>
        <population>Intent to Treat (ITT) population: All randomized participants administered with at least one study treatment during the study and provided at least one post baseline assessment of efficacy.</population>
        <group_list>
          <group group_id="O1">
            <title>5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate</title>
            <description>Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate</description>
          </group>
          <group group_id="O2">
            <title>Sodium Monofluorophosphate</title>
            <description>Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate</description>
          </group>
          <group group_id="O3">
            <title>Sodium Fluoride</title>
            <description>Dentifrice containing 1100 ppm fluoride as sodium fluoride</description>
          </group>
          <group group_id="O4">
            <title>0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate</title>
            <description>Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Evaporative Air Sensitivity Pain Response on Schiff Sensitivity Scale at Week 4</title>
          <description>Response to a constant jet of air applied to hypersensitive teeth was evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant does not respond to air stimulation, 1 - participant responds to air stimulus but does not request discontinuation of stimulus, 2 - participant responds to air stimulus and request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus.</description>
          <population>Intent to Treat (ITT) population: All randomized participants administered with at least one study treatment during the study and provided at least one post baseline assessment of efficacy.</population>
          <units>Score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="34"/>
                <count group_id="O3" value="33"/>
                <count group_id="O4" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.36" lower_limit="-0.53" upper_limit="-0.20"/>
                    <measurement group_id="O2" value="-0.43" lower_limit="-0.59" upper_limit="-0.27"/>
                    <measurement group_id="O3" value="-0.40" lower_limit="-0.57" upper_limit="-0.23"/>
                    <measurement group_id="O4" value="-0.45" lower_limit="-0.62" upper_limit="-0.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis considered change from baseline to be same for treatments in comparison.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.4553</p_value>
            <method>ANCOVA</method>
            <method_desc>From ANCOVA model with treatment and baseline included as covariate.</method_desc>
            <param_type>Adjusted Mean Difference</param_type>
            <param_value>0.09</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.14</ci_lower_limit>
            <ci_upper_limit>0.32</ci_upper_limit>
            <estimate_desc>Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis considered change from baseline to be same for treatments in comparison.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.5689</p_value>
            <method>ANCOVA</method>
            <method_desc>From ANCOVA model with treatment and baseline included as covariate.</method_desc>
            <param_type>Adjusted mean difference</param_type>
            <param_value>0.07</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.16</ci_lower_limit>
            <ci_upper_limit>0.30</ci_upper_limit>
            <estimate_desc>Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis considered change from baseline to be same for treatments in comparison.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.7517</p_value>
            <method>ANCOVA</method>
            <method_desc>From ANCOVA model with treatment and baseline included as covariate.</method_desc>
            <param_type>Adjusted Mean Difference</param_type>
            <param_value>0.04</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.20</ci_lower_limit>
            <ci_upper_limit>0.27</ci_upper_limit>
            <estimate_desc>Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis considered change from baseline to be same for treatments in comparison.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.8549</p_value>
            <method>ANCOVA</method>
            <method_desc>From ANCOVA model with treatment and baseline included as covariate.</method_desc>
            <param_type>Adjusted Mean Difference</param_type>
            <param_value>0.02</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.21</ci_lower_limit>
            <ci_upper_limit>0.25</ci_upper_limit>
            <estimate_desc>Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis considered change from baseline to be same for treatments in comparison.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.6685</p_value>
            <method>ANCOVA</method>
            <method_desc>From ANCOVA model with treatment and baseline included as covariate.</method_desc>
            <param_type>Adjusted mean difference</param_type>
            <param_value>0.05</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.18</ci_lower_limit>
            <ci_upper_limit>0.29</ci_upper_limit>
            <estimate_desc>Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis considered change from baseline to be same for treatments in comparison.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.8031</p_value>
            <method>ANCOVA</method>
            <param_type>Adjusted Mean Difference</param_type>
            <param_value>-0.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.26</ci_lower_limit>
            <ci_upper_limit>0.20</ci_upper_limit>
            <estimate_desc>Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Tactile Sensitivity Pain Response (g) at Week 4</title>
        <description>Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. In tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response was recorded or the maximum force was reached.</description>
        <time_frame>Baseline to 4 weeks post administration of study treatment</time_frame>
        <population>ITT population: All randomized participants administered with at least one study treatment during the study and provided at least one post baseline assessment of efficacy.</population>
        <group_list>
          <group group_id="O1">
            <title>5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate</title>
            <description>Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate</description>
          </group>
          <group group_id="O2">
            <title>Sodium Monofluorophosphate</title>
            <description>Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate</description>
          </group>
          <group group_id="O3">
            <title>Sodium Fluoride</title>
            <description>Dentifrice containing 1100 ppm fluoride as sodium fluoride</description>
          </group>
          <group group_id="O4">
            <title>0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate</title>
            <description>Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Tactile Sensitivity Pain Response (g) at Week 4</title>
          <description>Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. In tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response was recorded or the maximum force was reached.</description>
          <population>ITT population: All randomized participants administered with at least one study treatment during the study and provided at least one post baseline assessment of efficacy.</population>
          <units>grams</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="34"/>
                <count group_id="O3" value="33"/>
                <count group_id="O4" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.31" spread="11.227"/>
                    <measurement group_id="O2" value="6.32" spread="13.045"/>
                    <measurement group_id="O3" value="4.09" spread="4.752"/>
                    <measurement group_id="O4" value="3.64" spread="6.030"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis considered change from baseline to be same for treatments in comparison.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0467</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
            <method_desc>Hodges-Lehmann Wilcoxon non-parametric test</method_desc>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0</ci_lower_limit>
            <ci_upper_limit>5</ci_upper_limit>
            <estimate_desc>Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis considered change from baseline to be same for treatments in comparison.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.1133</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
            <method_desc>Hodges-Lehmann Wilcoxon non-parametric test.</method_desc>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0</ci_lower_limit>
            <ci_upper_limit>5</ci_upper_limit>
            <estimate_desc>Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis considered change from baseline to be same for treatments in comparison.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.2579</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
            <method_desc>Hodges-Lehmann Wilcoxon non-parametric test</method_desc>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>0</param_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>0</ci_lower_limit>
            <ci_upper_limit>5</ci_upper_limit>
            <estimate_desc>Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis considered change from baseline to be same for treatments in comparison.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.6149</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
            <method_desc>Hodges-Lehmann Wilcoxon non-parametric test.</method_desc>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0</ci_lower_limit>
            <ci_upper_limit>0</ci_upper_limit>
            <estimate_desc>Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis considered change from baseline to be same for treatments in comparison.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.3259</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
            <method_desc>Hodges-Lehmann Wilcoxon non-parametric test</method_desc>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0</ci_lower_limit>
            <ci_upper_limit>5</ci_upper_limit>
            <estimate_desc>Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis considered change from baseline to be same for treatments in comparison.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.5721</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
            <method_desc>Hodges-Lehmann Wilcoxon non-parametric test</method_desc>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0</ci_lower_limit>
            <ci_upper_limit>0</ci_upper_limit>
            <estimate_desc>Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Evaporative Air Sensitivity Pain Response on Schiff Sensitivity Scale at Week 8</title>
        <description>Response to a constant jet of air applied to hypersensitive teeth was evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant does not respond to air stimulation, 1 - participant responds to air stimulus but does not request discontinuation of stimulus, 2 - participant responds to air stimulus and request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus.</description>
        <time_frame>Baseline to 8 weeks post administration of study treatment</time_frame>
        <population>ITT population: All randomized participants administered with at least one study treatment during the study and provided at least one post baseline assessment of efficacy.</population>
        <group_list>
          <group group_id="O1">
            <title>5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate</title>
            <description>Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate</description>
          </group>
          <group group_id="O2">
            <title>Sodium Monofluorophosphate</title>
            <description>Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate</description>
          </group>
          <group group_id="O3">
            <title>Sodium Fluoride</title>
            <description>Dentifrice containing 1100 ppm fluoride as sodium fluoride</description>
          </group>
          <group group_id="O4">
            <title>0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate</title>
            <description>Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Evaporative Air Sensitivity Pain Response on Schiff Sensitivity Scale at Week 8</title>
          <description>Response to a constant jet of air applied to hypersensitive teeth was evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant does not respond to air stimulation, 1 - participant responds to air stimulus but does not request discontinuation of stimulus, 2 - participant responds to air stimulus and request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus.</description>
          <population>ITT population: All randomized participants administered with at least one study treatment during the study and provided at least one post baseline assessment of efficacy.</population>
          <units>Score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="34"/>
                <count group_id="O3" value="33"/>
                <count group_id="O4" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.55" lower_limit="-0.78" upper_limit="-0.33"/>
                    <measurement group_id="O2" value="-0.43" lower_limit="-0.66" upper_limit="-0.20"/>
                    <measurement group_id="O3" value="-0.43" lower_limit="-0.66" upper_limit="-0.20"/>
                    <measurement group_id="O4" value="-0.92" lower_limit="-1.15" upper_limit="-0.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis considered change from baseline to be same for treatments in comparison.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0292</p_value>
            <method>ANCOVA</method>
            <method_desc>From ANCOVA model with treatment and baseline included as covariate.</method_desc>
            <param_type>Adjusted Mean Difference</param_type>
            <param_value>0.36</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.04</ci_lower_limit>
            <ci_upper_limit>0.69</ci_upper_limit>
            <estimate_desc>Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis considered change from baseline to be same for treatments in comparison.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.4484</p_value>
            <method>ANCOVA</method>
            <method_desc>From ANCOVA model with treatment and baseline included as covariate.</method_desc>
            <param_type>Adjusted Mean Difference</param_type>
            <param_value>-0.12</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.44</ci_lower_limit>
            <ci_upper_limit>0.20</ci_upper_limit>
            <estimate_desc>Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis considered change from baseline to be same for treatments in comparison.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.4537</p_value>
            <method>ANCOVA</method>
            <method_desc>From ANCOVA model with treatment and baseline included as covariate.</method_desc>
            <param_type>Adjusted Mean Difference</param_type>
            <param_value>-0.12</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.45</ci_lower_limit>
            <ci_upper_limit>0.20</ci_upper_limit>
            <estimate_desc>Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis considered change from baseline to be same for treatments in comparison.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0037</p_value>
            <method>ANCOVA</method>
            <method_desc>From ANCOVA model with treatment and baseline included as covariate.</method_desc>
            <param_type>Adjusted Mean Difference</param_type>
            <param_value>0.49</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.16</ci_lower_limit>
            <ci_upper_limit>0.81</ci_upper_limit>
            <estimate_desc>Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis considered change from baseline to be same for treatments in comparison.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0040</p_value>
            <method>ANCOVA</method>
            <method_desc>From ANCOVA model with treatment and baseline included as covariate.</method_desc>
            <param_type>Adjusted Mean Difference</param_type>
            <param_value>0.48</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.16</ci_lower_limit>
            <ci_upper_limit>0.81</ci_upper_limit>
            <estimate_desc>Treatment as fixed factor, baseline Schiff score as covariate. Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis considered change from baseline to be same for treatments in comparison.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.9974</p_value>
            <method>ANCOVA</method>
            <method_desc>From ANCOVA model with treatment and baseline included as covariate.</method_desc>
            <param_type>Adjusted Mean Difference</param_type>
            <param_value>0.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.32</ci_lower_limit>
            <ci_upper_limit>0.32</ci_upper_limit>
            <estimate_desc>Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Tactile Sensitivity Pain Response (g) at Week 8</title>
        <description>Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. In tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response was recorded or the maximum force was reached.</description>
        <time_frame>Baseline to 8 weeks post administration of study treatment</time_frame>
        <population>ITT population: All randomized participants administered with at least one study treatment during the study and provided at least one post baseline assessment of efficacy.</population>
        <group_list>
          <group group_id="O1">
            <title>5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate</title>
            <description>Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate</description>
          </group>
          <group group_id="O2">
            <title>Sodium Monofluorophosphate</title>
            <description>Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate</description>
          </group>
          <group group_id="O3">
            <title>Sodium Fluoride</title>
            <description>Dentifrice containing 1100 ppm fluoride as sodium fluoride</description>
          </group>
          <group group_id="O4">
            <title>0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate</title>
            <description>Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Tactile Sensitivity Pain Response (g) at Week 8</title>
          <description>Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. In tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response was recorded or the maximum force was reached.</description>
          <population>ITT population: All randomized participants administered with at least one study treatment during the study and provided at least one post baseline assessment of efficacy.</population>
          <units>grams</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="34"/>
                <count group_id="O3" value="33"/>
                <count group_id="O4" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.15" spread="15.100"/>
                    <measurement group_id="O2" value="5.88" spread="11.512"/>
                    <measurement group_id="O3" value="4.39" spread="5.556"/>
                    <measurement group_id="O4" value="11.97" spread="16.486"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis considered change from baseline to be same for treatments in comparison.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.8861</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
            <method_desc>Hodges-Lehmann Wilcoxon non-parametric test</method_desc>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5</ci_lower_limit>
            <ci_upper_limit>5</ci_upper_limit>
            <estimate_desc>Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis considered change from baseline to be same for treatments in comparison.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0641</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
            <method_desc>Hodges-Lehmann Wilcoxon non-parametric test</method_desc>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0</ci_lower_limit>
            <ci_upper_limit>5</ci_upper_limit>
            <estimate_desc>Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis considered change from baseline to be same for treatments in comparison.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.1831</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
            <method_desc>Hodges-Lehmann Wilcoxon non-parametric test</method_desc>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>0</param_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>0</ci_lower_limit>
            <ci_upper_limit>5</ci_upper_limit>
            <estimate_desc>Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis considered change from baseline to be same for treatments in comparison.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0871</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
            <method_desc>Hodges-Lehmann Wilcoxon non-parametric test</method_desc>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-10</ci_lower_limit>
            <ci_upper_limit>0</ci_upper_limit>
            <estimate_desc>Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis considered change from baseline to be same for treatments in comparison.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.1690</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
            <method_desc>Hodges-Lehmann Wilcoxon non-parametric test</method_desc>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-10</ci_lower_limit>
            <ci_upper_limit>0</ci_upper_limit>
            <estimate_desc>Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis considered change from baseline to be same for treatments in comparison.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.3829</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
            <method_desc>Hodges-Lehmann Wilcoxon non-parametric test</method_desc>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5</ci_lower_limit>
            <ci_upper_limit>0</ci_upper_limit>
            <estimate_desc>Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Evaporative Air Sensitivity Response on a Visual Rating Scale (VRS) at Week 4</title>
        <description>Participants rated the intensity of their response to the stimulus using a 10 point Visual rating scale of 1 (no Pain) to 10 (intense pain).</description>
        <time_frame>Baseline to 4 weeks post administration of study treatment</time_frame>
        <population>ITT population: All randomized participants administered with at least one study treatment during the study and provided at least one post baseline assessment of efficacy.</population>
        <group_list>
          <group group_id="O1">
            <title>5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate</title>
            <description>Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate</description>
          </group>
          <group group_id="O2">
            <title>Sodium Monofluorophosphate</title>
            <description>Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate</description>
          </group>
          <group group_id="O3">
            <title>Sodium Fluoride</title>
            <description>Dentifrice containing 1100 ppm fluoride as sodium fluoride</description>
          </group>
          <group group_id="O4">
            <title>0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate</title>
            <description>Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Evaporative Air Sensitivity Response on a Visual Rating Scale (VRS) at Week 4</title>
          <description>Participants rated the intensity of their response to the stimulus using a 10 point Visual rating scale of 1 (no Pain) to 10 (intense pain).</description>
          <population>ITT population: All randomized participants administered with at least one study treatment during the study and provided at least one post baseline assessment of efficacy.</population>
          <units>Score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="34"/>
                <count group_id="O3" value="33"/>
                <count group_id="O4" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.22" lower_limit="-1.76" upper_limit="-0.69"/>
                    <measurement group_id="O2" value="-1.07" lower_limit="-1.60" upper_limit="-0.55"/>
                    <measurement group_id="O3" value="-1.35" lower_limit="-1.89" upper_limit="-0.81"/>
                    <measurement group_id="O4" value="-1.25" lower_limit="-1.80" upper_limit="-0.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis considered change from baseline to be same for treatments in comparison.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.9421</p_value>
            <method>ANCOVA</method>
            <method_desc>ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.</method_desc>
            <param_type>Adjusted Mean Difference</param_type>
            <param_value>0.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.74</ci_lower_limit>
            <ci_upper_limit>0.80</ci_upper_limit>
            <estimate_desc>Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis considered change from baseline to be same for treatments in comparison.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.6918</p_value>
            <method>ANCOVA</method>
            <method_desc>ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.</method_desc>
            <param_type>Adjusted Mean Difference</param_type>
            <param_value>-0.15</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.90</ci_lower_limit>
            <ci_upper_limit>0.60</ci_upper_limit>
            <estimate_desc>Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis considered change from baseline to be same for treatments in comparison.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.7421</p_value>
            <method>ANCOVA</method>
            <method_desc>From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.</method_desc>
            <param_type>Adjusted Mean Difference</param_type>
            <param_value>0.13</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.63</ci_lower_limit>
            <ci_upper_limit>0.88</ci_upper_limit>
            <estimate_desc>Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis considered change from baseline to be same for treatments in comparison.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.6433</p_value>
            <method>ANCOVA</method>
            <method_desc>From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.</method_desc>
            <param_type>Adjusted Mean Difference</param_type>
            <param_value>0.18</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.58</ci_lower_limit>
            <ci_upper_limit>0.94</ci_upper_limit>
            <estimate_desc>Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis considered change from baseline to be same for treatments in comparison.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.8010</p_value>
            <method>ANCOVA</method>
            <method_desc>From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.</method_desc>
            <param_type>Adjusted Mean Difference</param_type>
            <param_value>-0.10</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.86</ci_lower_limit>
            <ci_upper_limit>0.67</ci_upper_limit>
            <estimate_desc>Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis considered change from baseline to be same for treatments in comparison.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.4692</p_value>
            <method>ANCOVA</method>
            <method_desc>From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.</method_desc>
            <param_type>Adjusted Mean Difference</param_type>
            <param_value>0.28</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.48</ci_lower_limit>
            <ci_upper_limit>1.03</ci_upper_limit>
            <estimate_desc>Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Evaporative Air Sensitivity Response on VRS at Week 8</title>
        <description>Participants rated the intensity of their response to the stimulus using a 10 point VRS of 1 (no Pain) to 10 (intense pain).</description>
        <time_frame>Baseline to 8 weeks post administration of study treatment</time_frame>
        <population>ITT population: All randomized participants administered with at least one study treatment during the study and provided at least one post baseline assessment of efficacy.</population>
        <group_list>
          <group group_id="O1">
            <title>5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate</title>
            <description>Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate</description>
          </group>
          <group group_id="O2">
            <title>Sodium Monofluorophosphate</title>
            <description>Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate</description>
          </group>
          <group group_id="O3">
            <title>Sodium Fluoride</title>
            <description>Dentifrice containing 1100 ppm fluoride as sodium fluoride</description>
          </group>
          <group group_id="O4">
            <title>0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate</title>
            <description>Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Evaporative Air Sensitivity Response on VRS at Week 8</title>
          <description>Participants rated the intensity of their response to the stimulus using a 10 point VRS of 1 (no Pain) to 10 (intense pain).</description>
          <population>ITT population: All randomized participants administered with at least one study treatment during the study and provided at least one post baseline assessment of efficacy.</population>
          <units>Score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="34"/>
                <count group_id="O3" value="33"/>
                <count group_id="O4" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.76" lower_limit="-2.35" upper_limit="-1.17"/>
                    <measurement group_id="O2" value="-1.22" lower_limit="-1.81" upper_limit="-0.63"/>
                    <measurement group_id="O3" value="-1.31" lower_limit="-1.90" upper_limit="-0.71"/>
                    <measurement group_id="O4" value="-2.06" lower_limit="-2.67" upper_limit="-1.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis considered change from baseline to be same for treatments in comparison.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.4797</p_value>
            <method>ANCOVA</method>
            <method_desc>From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.</method_desc>
            <param_type>Adjusted Mean Difference</param_type>
            <param_value>0.31</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.55</ci_lower_limit>
            <ci_upper_limit>1.16</ci_upper_limit>
            <estimate_desc>Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis considered change from baseline to be same for treatments in comparison.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.2023</p_value>
            <method>ANCOVA</method>
            <method_desc>From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.</method_desc>
            <param_type>Adjusted Mean Difference</param_type>
            <param_value>-0.54</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.37</ci_lower_limit>
            <ci_upper_limit>0.29</ci_upper_limit>
            <estimate_desc>Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis considered change from baseline to be same for treatments in comparison.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.2917</p_value>
            <method>ANCOVA</method>
            <method_desc>From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.</method_desc>
            <param_type>Adjusted Mean Difference</param_type>
            <param_value>-0.45</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.29</ci_lower_limit>
            <ci_upper_limit>0.39</ci_upper_limit>
            <estimate_desc>Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis considered change from baseline to be same for treatments in comparison.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0503</p_value>
            <method>ANCOVA</method>
            <method_desc>From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.</method_desc>
            <param_type>Adjusted Mean Difference</param_type>
            <param_value>0.85</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.00</ci_lower_limit>
            <ci_upper_limit>1.69</ci_upper_limit>
            <estimate_desc>Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis considered change from baseline to be same for treatments in comparison.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0811</p_value>
            <method>ANCOVA</method>
            <method_desc>From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.</method_desc>
            <param_type>Adjusted Mean Difference</param_type>
            <param_value>0.76</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.09</ci_lower_limit>
            <ci_upper_limit>1.61</ci_upper_limit>
            <estimate_desc>Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis considered change from baseline to be same for treatments in comparison.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.8322</p_value>
            <method>ANCOVA</method>
            <method_desc>From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.</method_desc>
            <param_type>Adjusted Mean Difference</param_type>
            <param_value>0.09</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.75</ci_lower_limit>
            <ci_upper_limit>0.93</ci_upper_limit>
            <estimate_desc>Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate</title>
          <description>Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate</description>
        </group>
        <group group_id="E2">
          <title>0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate</title>
          <description>Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate</description>
        </group>
        <group group_id="E3">
          <title>Sodium Monofluorophosphate</title>
          <description>Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate</description>
        </group>
        <group group_id="E4">
          <title>Sodium Fluoride</title>
          <description>Dentifrice containing 1100 ppm fluoride as sodium fluoride</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="34"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="33"/>
              </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="34"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="33"/>
              </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/NCT01691560
org study id: RH01426
nct id: NCT01691560
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this exploratory study is to compare the treatment effect on dentinal
      hypersensitivity of a tubule occluding dentifrice as measured by Schiff and Tactile
      sensitivity. This proof of concept study will compare the test dentifrice with three other
      treatment groups.
This will be a single center, eight week, randomized, controlled, examiner blind, four
      treatment arm, parallel design, stratified (by maximum baseline Schiff Sensitivity Score of
      the two selected test teeth), exploratory study in participants with at least two sensitive
      teeth that meet all the criteria at the Screening and Baseline visit. Participants will be
      assessed at Baseline, four and eight weeks to monitor clinical efficacy and safety.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change From Baseline in Evaporative Air Sensitivity Pain Response on Schiff Sensitivity Scale at Week 4
time frame: Baseline to 4 weeks post administration of study treatment
description: Response to a constant jet of air applied to hypersensitive teeth was evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant does not respond to air stimulation, 1 - participant responds to air stimulus but does not request discontinuation of stimulus, 2 - participant responds to air stimulus and request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus.
measure: Change From Baseline in Tactile Sensitivity Pain Response (g) at Week 4
time frame: Baseline to 4 weeks post administration of study treatment
description: Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. In tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response was recorded or the maximum force was reached.
measure: Change From Baseline in Evaporative Air Sensitivity Pain Response on Schiff Sensitivity Scale at Week 8
time frame: Baseline to 8 weeks post administration of study treatment
description: Response to a constant jet of air applied to hypersensitive teeth was evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant does not respond to air stimulation, 1 - participant responds to air stimulus but does not request discontinuation of stimulus, 2 - participant responds to air stimulus and request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus.
measure: Change From Baseline in Tactile Sensitivity Pain Response (g) at Week 8
time frame: Baseline to 8 weeks post administration of study treatment
description: Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. In tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response was recorded or the maximum force was reached.
measure: Change From Baseline in Evaporative Air Sensitivity Response on a Visual Rating Scale (VRS) at Week 4
time frame: Baseline to 4 weeks post administration of study treatment
description: Participants rated the intensity of their response to the stimulus using a 10 point Visual rating scale of 1 (no Pain) to 10 (intense pain).
measure: Change From Baseline in Evaporative Air Sensitivity Response on VRS at Week 8
time frame: Baseline to 8 weeks post administration of study treatment
description: Participants rated the intensity of their response to the stimulus using a 10 point VRS of 1 (no Pain) to 10 (intense pain).
arm group label: 5% calcium sodium phosphosilicate/sodium monofluorophosphate
arm group type: Experimental
description: Dentifrice containing 5.0% w/w calcium sodium phosphosilicate with sodium monofluorophosphate containing 1500 parts per million fluoride (ppmF).
arm group label: 0% calcium sodium phosphosilicate/sodium monofluorophosphate
arm group type: Active Comparator
description: Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppmF as sodium monofluorophosphate
arm group label: Sodium monofluorophosphate
arm group type: Active Comparator
description: Dentifrice containing 1000 ppmF as sodium monofluorophosphate
arm group label: Sodium fluoride
arm group type: Active Comparator
description: Dentifrice containing 1100 ppmF as sodium fluoride
intervention type: Drug
intervention name: 5% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice
description: Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppmF as sodium monofluorophosphate
arm group label: 5% calcium sodium phosphosilicate/sodium monofluorophosphate
intervention type: Drug
intervention name: 0% calcium sodium phosphosilicate/sodium monofluorophosphate dentifrice
description: Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppmF as sodium monofluorophosphate
arm group label: 0% calcium sodium phosphosilicate/sodium monofluorophosphate
intervention type: Drug
intervention name: Sodium monofluorophosphate dentifrice
description: Dentifrice containing 1000 ppmF as sodium monofluorophosphate
arm group label: Sodium monofluorophosphate
intervention type: Drug
intervention name: Sodium fluoride dentifrice
description: Dentifrice containing 1100 ppmF as sodium fluoride
arm group label: Sodium fluoride
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
facility: 
country: United States
responsible party type: Sponsor
mesh term: Dentin Sensitivity
mesh term: Hypersensitivity
mesh term: Calcium, Dietary
mesh term: Listerine
mesh term: Calcium
mesh term: Fluorides
mesh term: Sodium Fluoride
mesh term: Fluorophosphate
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 