<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/NCT02226562</url>
  </required_header>
  <id_info>
    <org_study_id>202196</org_study_id>
    <secondary_id>RH02492</secondary_id>
    <nct_id>NCT02226562</nct_id>
  </id_info>
  <brief_title>Clinical Study Investigating the Efficacy of a Mouthwash in Providing Long Term Relief From Dentinal Hypersensitivity</brief_title>
  <official_title>A Clinical Study Investigating the Efficacy of a Mouthwash in Providing Long Term Relief From Dentinal Hypersensitivity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to investigate the longitudinal efficacy of a potassium nitrate&#xD;
      mouthwash formulation when used as an adjunct to brushing with a standard fluoride dentifrice&#xD;
      for the relief of dentinal hypersensitivity (DH) compared to brushing with a standard&#xD;
      fluoride dentifrice alone. This will be a single centre, eight week, randomised, examiner&#xD;
      blind, two treatment arm, parallel design, stratified (by maximum baseline Schiff Sensitivity&#xD;
      Score of the two selected test teeth) study in participants with at least two sensitive teeth&#xD;
      that meet all the criteria at the Screening and Baseline visit. Participants will be assessed&#xD;
      at Baseline, and at four and eight weeks to monitor clinical efficacy and safety.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2, 2014</start_date>
  <completion_date type="Actual">December 5, 2014</completion_date>
  <primary_completion_date type="Actual">December 1, 2014</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>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Change From Baseline in Schiff Sensitivity Score at Week 8</measure>
    <time_frame>Baseline to 8 week</time_frame>
    <description>The examiner indicated the participant's response to an evaporaitve air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score is indicative of an imrpovement in sensitivity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Schiff Sensitivity Score at Week 4</measure>
    <time_frame>Baseline to 4 week</time_frame>
    <description>The examiner indicated the participant's response to an evaporaitve air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score is indicative of an imrpovement in sensitivity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Tactile Threshold at Week 8</measure>
    <time_frame>Baseline to 8 week</time_frame>
    <description>The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Tactile Threshold at Week 4</measure>
    <time_frame>Baseline to 4 week</time_frame>
    <description>The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Visual Rating Scale (VRS) at Week 8</measure>
    <time_frame>Baseline to 8 week</time_frame>
    <description>Participants rated the intensity of their response to an evaporative air stimulus using a 10 point VRS scale with 1 indicating 'no pain' and 10 indicating 'Intense pain'. A reduction in the score is indicative of an improvement in sensitivity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in VRS at Week 4</measure>
    <time_frame>Baseline to 4 week</time_frame>
    <description>Participants rated the intensity of their response to an evaporative air stimulus using a 10 point VRS scale with 1 indicating 'no pain' and 10 indicating 'Intense pain'. A reduction in the score is indicative of an improvement in sensitivity.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">191</enrollment>
  <condition>Dentin Sensitivity</condition>
  <arm_group>
    <arm_group_label>Potassium nitrate and sodium fluoride</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3.0% weight by weight (w/w) potassium nitrate mouthwash with 0.02% sodium fluoride</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard fluoride dentifrice</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Standard fluoride dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate (SMFP)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Potassium nitrate and sodium fluoride</intervention_name>
    <description>3.0% w/w potassium nitrate mouthwash with 0.02% sodium fluoride</description>
    <arm_group_label>Potassium nitrate and sodium fluoride</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Standard fluoride dentifrice</intervention_name>
    <description>Standard fluoride dentifrice containing 1000 ppm fluoride as SMFP</description>
    <arm_group_label>Standard fluoride dentifrice</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants in good general health, with self-reported history of dentinal&#xD;
             hypersensitivity lasting more than 6 months but not more than 10 years.&#xD;
&#xD;
          -  Participants with minimum of 20 natural teeth.&#xD;
&#xD;
          -  At screening, a minimum of four, non-adjacent teeth.&#xD;
&#xD;
               1. Teeth showing signs of facial/cervical gingival recession and/or signs of erosion&#xD;
                  or abrasion.&#xD;
&#xD;
               2. Teeth with Gingival Index score ≤1 and a clinical mobility of ≤1.&#xD;
&#xD;
               3. Teeth that are determined to be sensitive by the participant following a 1 second&#xD;
                  air blast to the cervical margin.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of chronic debilitating disease which, in the opinion of the investigator,&#xD;
             could affect study outcomes.&#xD;
&#xD;
          -  Any condition which, in the opinion of the investigator, causes dry mouth.&#xD;
&#xD;
          -  Tooth with evidence of current or recent caries, or reported treatment of decay in 12&#xD;
             months of screening.&#xD;
&#xD;
          -  In the 8 weeks prior to screening use of an oral care product indicated for the relief&#xD;
             of DH.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Fort Wayne</city>
        <state>Indiana</state>
        <zip>46825</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>August 25, 2014</study_first_submitted>
  <study_first_submitted_qc>August 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2014</study_first_posted>
  <results_first_submitted>July 30, 2015</results_first_submitted>
  <results_first_submitted_qc>July 30, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">August 26, 2015</results_first_posted>
  <last_update_submitted>July 26, 2018</last_update_submitted>
  <last_update_submitted_qc>July 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 27, 2018</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>Listerine</mesh_term>
    <mesh_term>Fluorides</mesh_term>
    <mesh_term>Sodium Fluoride</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The participants were recruited at a clinical site in the USA</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Dentifrice Plus Oral Rinse</title>
          <description>3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice</description>
        </group>
        <group group_id="P2">
          <title>Dentifrice Alone</title>
          <description>Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="95"/>
                <participants group_id="P2" count="96"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="95"/>
                <participants group_id="P2" count="95">Lost to follow up</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Dentifrice Plus Oral Rinse</title>
          <description>3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice</description>
        </group>
        <group group_id="B2">
          <title>Dentifrice Alone</title>
          <description>Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)</description>
        </group>
        <group group_id="B3">
          <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="95"/>
            <count group_id="B2" value="96"/>
            <count group_id="B3" value="191"/>
          </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="41.7" spread="8.62"/>
                    <measurement group_id="B2" value="39.7" spread="8.14"/>
                    <measurement group_id="B3" value="40.7" spread="8.42"/>
                  </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="81"/>
                    <measurement group_id="B2" value="79"/>
                    <measurement group_id="B3" value="160"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mean Change From Baseline in Schiff Sensitivity Score at Week 8</title>
        <description>The examiner indicated the participant's response to an evaporaitve air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score is indicative of an imrpovement in sensitivity.</description>
        <time_frame>Baseline to 8 week</time_frame>
        <population>The primary population for efficacy assessment was intent-to-treat (ITT) population.The ITT population comprised of participants, who were randomized, received at least one dose of study treatment and provided at least one post-baseline assessment of efficacy.</population>
        <group_list>
          <group group_id="O1">
            <title>Dentifrice Plus Oral Rinse</title>
            <description>3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice</description>
          </group>
          <group group_id="O2">
            <title>Dentifrice Alone</title>
            <description>Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Schiff Sensitivity Score at Week 8</title>
          <description>The examiner indicated the participant's response to an evaporaitve air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score is indicative of an imrpovement in sensitivity.</description>
          <population>The primary population for efficacy assessment was intent-to-treat (ITT) population.The ITT population comprised of participants, who were randomized, received at least one dose of study treatment and provided at least one post-baseline assessment of efficacy.</population>
          <units>Score on scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="95"/>
                <count group_id="O2" value="95"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.47" spread="0.065"/>
                    <measurement group_id="O2" value="-0.37" spread="0.065"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0001</p_value>
            <p_value_desc>The P-value was less than 0.0001</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>ANCOVA with a factor for treatment and baseline as covariate</method_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-1.10</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.28</ci_lower_limit>
            <ci_upper_limit>-0.92</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Schiff Sensitivity Score at Week 4</title>
        <description>The examiner indicated the participant's response to an evaporaitve air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score is indicative of an imrpovement in sensitivity.</description>
        <time_frame>Baseline to 4 week</time_frame>
        <population>The primary population for efficacy assessment was intent-to-treat (ITT) population.The ITT population comprised of participants, who were randomized, received at least one dose of study treatment and provided at least one post-baseline assessment of efficacy.</population>
        <group_list>
          <group group_id="O1">
            <title>Dentifrice Plus Oral Rinse</title>
            <description>3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice</description>
          </group>
          <group group_id="O2">
            <title>Dentifrice Alone</title>
            <description>Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Schiff Sensitivity Score at Week 4</title>
          <description>The examiner indicated the participant's response to an evaporaitve air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score is indicative of an imrpovement in sensitivity.</description>
          <population>The primary population for efficacy assessment was intent-to-treat (ITT) population.The ITT population comprised of participants, who were randomized, received at least one dose of study treatment and provided at least one post-baseline assessment of efficacy.</population>
          <units>Scores on scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="95"/>
                <count group_id="O2" value="95"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.94" spread="0.719"/>
                    <measurement group_id="O2" value="-0.31" spread="0.542"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Tactile Threshold at Week 8</title>
        <description>The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.</description>
        <time_frame>Baseline to 8 week</time_frame>
        <population>The primary population for efficacy assessment was intent-to-treat (ITT) population.The ITT population comprised of participants, who were randomized, received at least one dose of study treatment and provided at least one post-baseline assessment of efficacy.</population>
        <group_list>
          <group group_id="O1">
            <title>Dentifrice Plus Oral Rinse</title>
            <description>3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice</description>
          </group>
          <group group_id="O2">
            <title>Dentifrice Alone</title>
            <description>Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Tactile Threshold at Week 8</title>
          <description>The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.</description>
          <population>The primary population for efficacy assessment was intent-to-treat (ITT) population.The ITT population comprised of participants, who were randomized, received at least one dose of study treatment and provided at least one post-baseline assessment of efficacy.</population>
          <units>Gram(g)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="95"/>
                <count group_id="O2" value="95"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.32" spread="27.869"/>
                    <measurement group_id="O2" value="3.74" spread="13.188"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Tactile Threshold at Week 4</title>
        <description>The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.</description>
        <time_frame>Baseline to 4 week</time_frame>
        <population>The primary population for efficacy assessment was intent-to-treat (ITT) population.The ITT population comprised of participants, who were randomized, received at least one dose of study treatment and provided at least one post-baseline assessment of efficacy.</population>
        <group_list>
          <group group_id="O1">
            <title>Dentifrice Plus Oral Rinse</title>
            <description>3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice</description>
          </group>
          <group group_id="O2">
            <title>Dentifrice Alone</title>
            <description>Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Tactile Threshold at Week 4</title>
          <description>The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.</description>
          <population>The primary population for efficacy assessment was intent-to-treat (ITT) population.The ITT population comprised of participants, who were randomized, received at least one dose of study treatment and provided at least one post-baseline assessment of efficacy.</population>
          <units>Gram (g)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="95"/>
                <count group_id="O2" value="95"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.11" spread="21.276"/>
                    <measurement group_id="O2" value="0.74" spread="4.434"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Visual Rating Scale (VRS) at Week 8</title>
        <description>Participants rated the intensity of their response to an evaporative air stimulus using a 10 point VRS scale with 1 indicating 'no pain' and 10 indicating 'Intense pain'. A reduction in the score is indicative of an improvement in sensitivity.</description>
        <time_frame>Baseline to 8 week</time_frame>
        <population>The primary population for efficacy assessment was intent-to-treat (ITT) population.The ITT population comprised of participants, who were randomized, received at least one dose of study treatment and provided at least one post-baseline assessment of efficacy.</population>
        <group_list>
          <group group_id="O1">
            <title>Dentifrice Plus Oral Rinse</title>
            <description>3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice</description>
          </group>
          <group group_id="O2">
            <title>Dentifrice Alone</title>
            <description>Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Visual Rating Scale (VRS) at Week 8</title>
          <description>Participants rated the intensity of their response to an evaporative air stimulus using a 10 point VRS scale with 1 indicating 'no pain' and 10 indicating 'Intense pain'. A reduction in the score is indicative of an improvement in sensitivity.</description>
          <population>The primary population for efficacy assessment was intent-to-treat (ITT) population.The ITT population comprised of participants, who were randomized, received at least one dose of study treatment and provided at least one post-baseline assessment of efficacy.</population>
          <units>Score on scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="95"/>
                <count group_id="O2" value="95"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.05" spread="2.038"/>
                    <measurement group_id="O2" value="-1.05" spread="1.673"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in VRS at Week 4</title>
        <description>Participants rated the intensity of their response to an evaporative air stimulus using a 10 point VRS scale with 1 indicating 'no pain' and 10 indicating 'Intense pain'. A reduction in the score is indicative of an improvement in sensitivity.</description>
        <time_frame>Baseline to 4 week</time_frame>
        <population>The primary population for efficacy assessment was intent-to-treat (ITT) population.The ITT population comprised of participants, who were randomized, received at least one dose of study treatment and provided at least one post-baseline assessment of efficacy.</population>
        <group_list>
          <group group_id="O1">
            <title>Dentifrice Plus Oral Rinse</title>
            <description>3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice</description>
          </group>
          <group group_id="O2">
            <title>Dentifrice Alone</title>
            <description>Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in VRS at Week 4</title>
          <description>Participants rated the intensity of their response to an evaporative air stimulus using a 10 point VRS scale with 1 indicating 'no pain' and 10 indicating 'Intense pain'. A reduction in the score is indicative of an improvement in sensitivity.</description>
          <population>The primary population for efficacy assessment was intent-to-treat (ITT) population.The ITT population comprised of participants, who were randomized, received at least one dose of study treatment and provided at least one post-baseline assessment of efficacy.</population>
          <units>Score on scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="95"/>
                <count group_id="O2" value="95"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.64" spread="1.651"/>
                    <measurement group_id="O2" value="-0.86" spread="1.295"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Upto 8 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Dentifrice Plus Oral Rinse</title>
          <description>3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice</description>
        </group>
        <group group_id="E2">
          <title>Dentifrice Alone</title>
          <description>Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)</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="95"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="96"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="95"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="96"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Sensitivity of teeth</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="95"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="96"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="95"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="96"/>
              </event>
              <event>
                <sub_title>Mouth ulceration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="95"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="96"/>
              </event>
              <event>
                <sub_title>Tooth impacted</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="95"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="96"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Device failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="95"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="96"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Vulvovaginal mycotic infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="95"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="96"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="95"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="96"/>
              </event>
              <event>
                <sub_title>Pharyngitis streptococcal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="95"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="96"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="95"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="96"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="95"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="96"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Traumatic ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="95"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="96"/>
              </event>
              <event>
                <sub_title>Epicondylitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="95"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="96"/>
              </event>
              <event>
                <sub_title>Mouth injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="95"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="96"/>
              </event>
              <event>
                <sub_title>Thermal burn</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="95"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="96"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypercholesterolemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="95"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="96"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="95"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="96"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="95"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="96"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis contact</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="95"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="96"/>
              </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/NCT02226562
org study id: 202196
secondary id: RH02492
nct id: NCT02226562
lead sponsor: 
has dmc: No
The aim of this study is to investigate the longitudinal efficacy of a potassium nitrate
      mouthwash formulation when used as an adjunct to brushing with a standard fluoride dentifrice
      for the relief of dentinal hypersensitivity (DH) compared to brushing with a standard
      fluoride dentifrice alone. This will be a single centre, eight week, randomised, examiner
      blind, two treatment arm, parallel design, stratified (by maximum baseline Schiff Sensitivity
      Score of the two selected test teeth) 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, and at four and eight weeks to monitor clinical efficacy and safety.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Mean Change From Baseline in Schiff Sensitivity Score at Week 8
time frame: Baseline to 8 week
description: The examiner indicated the participant's response to an evaporaitve air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score is indicative of an imrpovement in sensitivity.
measure: Mean Change From Baseline in Schiff Sensitivity Score at Week 4
time frame: Baseline to 4 week
description: The examiner indicated the participant's response to an evaporaitve air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score is indicative of an imrpovement in sensitivity.
measure: Mean Change From Baseline in Tactile Threshold at Week 8
time frame: Baseline to 8 week
description: The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.
measure: Mean Change From Baseline in Tactile Threshold at Week 4
time frame: Baseline to 4 week
description: The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.
measure: Mean Change From Baseline in Visual Rating Scale (VRS) at Week 8
time frame: Baseline to 8 week
description: Participants rated the intensity of their response to an evaporative air stimulus using a 10 point VRS scale with 1 indicating 'no pain' and 10 indicating 'Intense pain'. A reduction in the score is indicative of an improvement in sensitivity.
measure: Mean Change From Baseline in VRS at Week 4
time frame: Baseline to 4 week
description: Participants rated the intensity of their response to an evaporative air stimulus using a 10 point VRS scale with 1 indicating 'no pain' and 10 indicating 'Intense pain'. A reduction in the score is indicative of an improvement in sensitivity.
arm group label: Potassium nitrate and sodium fluoride
arm group type: Experimental
description: 3.0% weight by weight (w/w) potassium nitrate mouthwash with 0.02% sodium fluoride
arm group label: Standard fluoride dentifrice
arm group type: Other
description: Standard fluoride dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate (SMFP)
intervention type: Drug
intervention name: Potassium nitrate and sodium fluoride
description: 3.0% w/w potassium nitrate mouthwash with 0.02% sodium fluoride
arm group label: Potassium nitrate and sodium fluoride
intervention type: Drug
intervention name: Standard fluoride dentifrice
description: Standard fluoride dentifrice containing 1000 ppm fluoride as SMFP
arm group label: Standard fluoride dentifrice
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
facility: 
country: United States
responsible party type: Sponsor
mesh term: Dentin Sensitivity
mesh term: Hypersensitivity
mesh term: Listerine
mesh term: Fluorides
mesh term: Sodium Fluoride
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 