<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/NCT03238352</url>
  </required_header>
  <id_info>
    <org_study_id>207656</org_study_id>
    <nct_id>NCT03238352</nct_id>
  </id_info>
  <brief_title>A Study to Assess Efficacy of an Experimental Oral Rinse in Providing Long Term Relief From Dentinal Hypersensitivity</brief_title>
  <official_title>A Method Development Clinical Study Investigating the Efficacy of an Experimental Oral Rinse 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>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigate the efficacy of an experimental oral rinse, containing 1.5% potassium oxalate&#xD;
      (KOX) and 0 parts per million (ppm) fluoride in relieving dentine hypersensitivity (DH) after&#xD;
      8 weeks use compared with a placebo oral rinse and a commercialized fluoride oral rinse.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This will be a single centre, eight week, randomized, examiner-blind, three treatment,&#xD;
      parallel group, stratified study. It will be conducted in healthy participants, with at least&#xD;
      two sensitive teeth that meet all of the study criteria at the Screening and Baseline visits.&#xD;
      DH will be assessed at Baseline, and after 4 and 8 weeks twice daily treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 7, 2017</start_date>
  <completion_date type="Actual">October 27, 2017</completion_date>
  <primary_completion_date type="Actual">October 27, 2017</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>Change From Baseline in Schiff Sensitivity Score</measure>
    <time_frame>Week 8</time_frame>
    <description>The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale which was scored as follows - 0: Participant did not respond to air stimulation; 1: Participant responded to air stimulus but does not request discontinuation of stimulus; 2: Participant responded to air stimulus and requested discontinuation or moves from stimulus; 3: Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus. A reduction in Schiff Sensitivity score will be indicative of an improvement in sensitivity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Tactile Threshold</measure>
    <time_frame>Week 8</time_frame>
    <description>The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed the application of a known force to the dentin surface, starting at 10 grams (g) 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 participant whether the sensation caused discomfort. The pressure setting at which the participant 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>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">89</enrollment>
  <condition>Dentin Sensitivity</condition>
  <arm_group>
    <arm_group_label>Test Product</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will rinse twice daily (morning and evening) with 10 milliliters (mL) of oral rinse for 60 timed seconds and expectorate. No further rinsing with water will be permitted after use of the oral rinse.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Negative Control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants will rinse twice daily (morning and evening) with 10 mL of oral rinse for 60 timed seconds and expectorate. No further rinsing with water will be permitted after use of the oral rinse.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will rinse twice daily (morning and evening) with 10 mL of oral rinse for 60 timed seconds and expectorate. No further rinsing with water will be permitted after use of the oral rinse.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Potassium oxalate</intervention_name>
    <description>Oral rinse containing 1.5 percent (%) KOX and 0 ppm fluoride</description>
    <arm_group_label>Test Product</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sodium fluoride</intervention_name>
    <description>Oral rinse containing 0.02% weight by weight (w/w) sodium fluoride (NaF)</description>
    <arm_group_label>Negative Control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Oral rinse containing 0% KOX and 0 ppm fluoride</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Demonstrates understanding of the study procedures, restrictions and willingness to&#xD;
             participate as evidenced by voluntary written informed consent and has received a&#xD;
             signed and dated copy of the informed consent form.&#xD;
&#xD;
          -  Good general and mental health with, in the opinion of the investigator or medically&#xD;
             qualified designee: a) No clinically significant and relevant abnormalities in medical&#xD;
             history or oral Examination and b) Absence of any condition that would impact on the&#xD;
             participant's safety or wellbeing or affect the individual's ability to understand and&#xD;
             follow study procedures and requirements.&#xD;
&#xD;
          -  Dental Health at Screening: a) Self-reported history of DH lasting more than six&#xD;
             months but not more than 10 Years, b) Minimum of 20 natural teeth, c) Minimum of 4&#xD;
             accessible non-adjacent teeth (incisors, canines, premolars), preferably in different&#xD;
             quadrants, that meet all of the following criteria: Signs of facial/cervical gingival&#xD;
             recession and/or signs of erosion or abrasion (EAR), Tooth with MGI score =0 adjacent&#xD;
             to the test area (exposed dentine) only and a clinical mobility of ≤1 and tooth with&#xD;
             signs of sensitivity measured by qualifying evaporative air assessment (Schiff&#xD;
             sensitivity score ≥ 2).&#xD;
&#xD;
          -  Dental Health at Baseline: Minimum of two, non-adjacent accessible teeth (incisors,&#xD;
             canines, premolars), that meet all of the following criteria: Tooth with signs of&#xD;
             sensitivity, measured by qualifying tactile stimulus (Yeaple ≤20g) and evaporative air&#xD;
             assessment (Schiff sensitivity score ≥ 2.&#xD;
&#xD;
          -  Females of childbearing potential who are, in the opinion of the investigator,&#xD;
             practicing a reliable method of contraception. Adequate contraception is defined as&#xD;
             abstinence, oral contraceptive, either combined or progestogen alone or injectable&#xD;
             progestogen or implants of levonorgestrel or estrogenic vaginal ring or percutaneous&#xD;
             contraceptive patches or intrauterine device or intrauterine system or double barrier&#xD;
             method (condom or occlusive cap [diaphragm or cervical vault caps] plus spermicidal&#xD;
             agent [foam, gel, film, cream, suppository]) or male partner sterilization prior to&#xD;
             the female participant's entry into the study, and this male is the sole partner for&#xD;
             that participant).&#xD;
&#xD;
          -  Participant will be current and regular (twice daily), users of an over the counter&#xD;
             (OTC) Monograph or cosmetic oral rinse.&#xD;
&#xD;
          -  Participant will be cell phone owners so that they can contactable by SMS.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A woman who is known to be pregnant or who is intending to become pregnant over the&#xD;
             duration of the study.&#xD;
&#xD;
          -  A woman who is breast-feeding.&#xD;
&#xD;
          -  Known or suspected intolerance or hypersensitivity to the study materials (or closely&#xD;
             related compounds) or any of their stated ingredients.&#xD;
&#xD;
          -  Participation in another clinical study (including cosmetic studies) or receipt of an&#xD;
             investigational drug within 30 days of the screening visit or previous participation&#xD;
             in this study.&#xD;
&#xD;
          -  Recent history (within the last year) of alcohol or other substance abuse.&#xD;
&#xD;
          -  An employee of the sponsor or the study site or members of their immediate family.&#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 xerostomia.&#xD;
&#xD;
          -  Dental prophylaxis within 4 weeks of Screening.&#xD;
&#xD;
          -  Tongue or lip piercing.&#xD;
&#xD;
          -  Desensitizing treatment within 8 weeks of Screening (professional sensitivity,&#xD;
             treatments and non-dentifrice sensitivity treatments).&#xD;
&#xD;
          -  Gross periodontal disease, treatment of periodontal disease (including surgery) within&#xD;
             12 months of Screening, scaling or root planning within 3 months of Screening.&#xD;
&#xD;
          -  Teeth bleaching and any teeth whitening procedures within 8 weeks of Screening.&#xD;
&#xD;
          -  Tooth with evidence of current or recent caries, or reported treatment of decay within&#xD;
             12 months of Screening.&#xD;
&#xD;
          -  Tooth with exposed dentine but with deep, defective or facial restorations, teeth used&#xD;
             as abutments for fixed or removable partial dentures, dental implants, teeth with full&#xD;
             crowns or veneers, orthodontic bands or cracked enamel. Sensitive teeth with&#xD;
             contributing aetiologies other than erosion, abrasion or recession of exposed dentine.&#xD;
&#xD;
          -  Sensitive tooth not expected to respond to treatment with an over-the-counter&#xD;
             dentifrice in the opinion of the investigator.&#xD;
&#xD;
          -  Use of an oral care product indicated for the relief of dentine hypersensitivity&#xD;
             within 8 weeks of screening (Participants will be required to bring their current oral&#xD;
             care products to the site in order to verify the absence of known anti-sensitivity&#xD;
             ingredients).&#xD;
&#xD;
          -  Daily doses of medication/treatments which, in the opinion of the investigator, could&#xD;
             interfere with the perception of pain. Examples of such medications include&#xD;
             analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation,&#xD;
             sedatives, tranquilisers, anti-depressants, mood-altering and anti-inflammatory drugs.&#xD;
&#xD;
          -  Currently taking antibiotics or has taken antibiotics within two weeks of Baseline.&#xD;
&#xD;
          -  Daily dose of a medication which, in the opinion of the investigator, is causing&#xD;
             xerostomia.&#xD;
&#xD;
          -  Presence of kidney disease, hyperoxaluria, or any other condition that may be&#xD;
             exacerbated by oxalic acid or oxalate salts.&#xD;
&#xD;
          -  Presence of chronic debilitating disease which, in the opinion of the investigator,&#xD;
             could affect study outcomes.&#xD;
&#xD;
          -  Any participant who, in the judgment of the investigator, should not participate in&#xD;
             the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>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>October 2018</verification_date>
  <study_first_submitted>July 19, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <results_first_submitted>October 15, 2018</results_first_submitted>
  <results_first_submitted_qc>October 15, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">November 14, 2018</results_first_posted>
  <last_update_submitted>October 15, 2018</last_update_submitted>
  <last_update_submitted_qc>October 15, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 14, 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>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 25, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/52/NCT03238352/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 5, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/52/NCT03238352/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were recruited from one center in USA.</recruitment_details>
      <pre_assignment_details>A total of 123 participates were screened, out of which 89 participants were enrolled and randomized in the study. 34 participants were not randomized as all the 34 participants did not meet study criteria.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Test Product (1.5% KOX, 0 Ppm Fluoride, pH 7)</title>
          <description>Participants rinsed twice daily (morning and evening) with 10 milliliters (mL) of oral rinse (1.5% KOX, 0 parts per million [ppm] fluoride, pH 7) for 60 seconds using standard fluoride dentifrice and then expectorated. No further rinsing with water was allowed after use of the oral rinse. This regimen was performed twice daily for 8 weeks.</description>
        </group>
        <group group_id="P2">
          <title>Negative Control (0.02% w/w Sodium Fluoride)</title>
          <description>Participants rinsed twice daily (morning and evening) with 10 mL of oral rinse (0.02% weight by weight [w/w] sodium fluoride) for 60 seconds using standard fluoride dentifrice and then expectorated. No further rinsing with water was allowed after use of the oral rinse. This regimen was performed twice daily for 8 weeks.</description>
        </group>
        <group group_id="P3">
          <title>Placebo (0% KOX, 0 Ppm Fluoride, pH 7)</title>
          <description>Participants rinsed twice daily (morning and evening) with 10 mL of oral rinse (0% KOX, 0 ppm fluoride, pH 7) for 60 seconds using standard fluoride dentifrice and then expectorated. No further rinsing with water was allowed after use of the oral rinse. This regimen was performed twice daily for 8 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="43"/>
                <participants group_id="P2" count="23"/>
                <participants group_id="P3" count="23"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="43"/>
                <participants group_id="P2" count="20"/>
                <participants group_id="P3" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety population comprised of all randomized participants who received at least 1 dose of study treatment. This population was based on the treatment the participant actually received.</population>
      <group_list>
        <group group_id="B1">
          <title>Test Product (1.5% KOX, 0 Ppm Fluoride, pH 7)</title>
          <description>Participants rinsed twice daily (morning and evening) with 10 mL of oral rinse (1.5% KOX, 0 ppm fluoride, pH 7) for 60 seconds using standard fluoride dentifrice and then expectorated. No further rinsing with water was allowed after use of the oral rinse. This regimen was performed twice daily for 8 weeks.</description>
        </group>
        <group group_id="B2">
          <title>Negative Control (0.02% w/w Sodium Fluoride)</title>
          <description>Participants rinsed twice daily (morning and evening) with 10 mL of oral rinse (0.02% w/w sodium fluoride) for 60 seconds using standard fluoride dentifrice and then expectorated. No further rinsing with water was allowed after use of the oral rinse. This regimen was performed twice daily for 8 weeks.</description>
        </group>
        <group group_id="B3">
          <title>Placebo (0% KOX, 0 Ppm Fluoride, pH 7)</title>
          <description>Participants rinsed twice daily (morning and evening) with 10 mL of oral rinse (0% KOX, 0 ppm fluoride, pH 7) for 60 seconds using standard fluoride dentifrice and then expectorated. No further rinsing with water was allowed after use of the oral rinse. This regimen was performed twice daily for 8 weeks.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="43"/>
            <count group_id="B2" value="23"/>
            <count group_id="B3" value="23"/>
            <count group_id="B4" value="89"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="46.0" spread="9.27"/>
                    <measurement group_id="B2" value="41.5" spread="9.76"/>
                    <measurement group_id="B3" value="43.0" spread="8.75"/>
                    <measurement group_id="B4" value="44.1" spread="9.38"/>
                  </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="37"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="23"/>
                    <measurement group_id="B4" value="79"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="22"/>
                    <measurement group_id="B4" value="86"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="20"/>
                    <measurement group_id="B4" value="77"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Schiff Sensitivity Score</title>
        <description>The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale which was scored as follows - 0: Participant did not respond to air stimulation; 1: Participant responded to air stimulus but does not request discontinuation of stimulus; 2: Participant responded to air stimulus and requested discontinuation or moves from stimulus; 3: Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus. A reduction in Schiff Sensitivity score will be indicative of an improvement in sensitivity.</description>
        <time_frame>Week 8</time_frame>
        <population>The Intent-to-Treat (ITT) (N=85) population comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline efficacy evaluation. This population was based on the treatment to which the participant was randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>Test Product (1.5% KOX, 0 Ppm Fluoride, pH 7)</title>
            <description>Participants rinsed twice daily (morning and evening) with 10 mL of oral rinse (1.5% KOX, 0 ppm fluoride, pH 7) for 60 seconds using standard fluoride dentifrice and then expectorated. No further rinsing with water was allowed after use of the oral rinse. This regimen was performed twice daily for 8 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Negative Control (0.02% w/w Sodium Fluoride)</title>
            <description>Participants rinsed twice daily (morning and evening) with 10 mL of oral rinse (0.02% w/w sodium fluoride) for 60 seconds using standard fluoride dentifrice and then expectorated. No further rinsing with water was allowed after use of the oral rinse. This regimen was performed twice daily for 8 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Placebo (0% KOX, 0 Ppm Fluoride, pH 7)</title>
            <description>Participants rinsed twice daily (morning and evening) with 10 mL of oral rinse (0% KOX, 0 ppm fluoride, pH 7) for 60 seconds using standard fluoride dentifrice and then expectorated. No further rinsing with water was allowed after use of the oral rinse. This regimen was performed twice daily for 8 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Schiff Sensitivity Score</title>
          <description>The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale which was scored as follows - 0: Participant did not respond to air stimulation; 1: Participant responded to air stimulus but does not request discontinuation of stimulus; 2: Participant responded to air stimulus and requested discontinuation or moves from stimulus; 3: Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus. A reduction in Schiff Sensitivity score will be indicative of an improvement in sensitivity.</description>
          <population>The Intent-to-Treat (ITT) (N=85) population comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline efficacy evaluation. This population was based on the treatment to which the participant was randomized.</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="43"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Schiff score at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.59" spread="0.382"/>
                    <measurement group_id="O2" value="2.68" spread="0.406"/>
                    <measurement group_id="O3" value="2.52" spread="0.361"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline in Schiff score at Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.94" spread="0.773"/>
                    <measurement group_id="O2" value="-0.75" spread="0.866"/>
                    <measurement group_id="O3" value="-0.64" spread="0.848"/>
                  </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>
            <groups_desc>Test Product versus Negative Control at Week 8 is a primary endpoint comparison.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>ANCOVA</method>
            <method_desc>From ANCOVA model with treatment as factor and baseline Schiff score as covariate.</method_desc>
            <param_type>Difference of Least Square mean</param_type>
            <param_value>-1.22</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.220</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.657</ci_lower_limit>
            <ci_upper_limit>-0.782</ci_upper_limit>
            <estimate_desc>Difference is first named treatment minus second named treatment such that a negative 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>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <method>ANCOVA</method>
            <method_desc>From ANCOVA model with treatment as factor and baseline Schiff score as covariate.</method_desc>
            <param_type>Difference of Least Square mean</param_type>
            <param_value>-1.28</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.213</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.705</ci_lower_limit>
            <ci_upper_limit>-0.858</ci_upper_limit>
            <estimate_desc>Difference is first named treatment minus second named treatment such that a negative 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>O3</group_id>
            </group_id_list>
            <groups_desc>Test Product versus Combined Control (Placebo and Negative Control) group was obtained by using estimates statement in the ANCOVA model.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>ANCOVA</method>
            <method_desc>From ANCOVA model with treatment as factor and baseline Schiff score as covariate.</method_desc>
            <param_type>Difference of Least Square mean</param_type>
            <param_value>-1.25</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.176</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.600</ci_lower_limit>
            <ci_upper_limit>-0.901</ci_upper_limit>
            <estimate_desc>Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Tactile Threshold</title>
        <description>The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed the application of a known force to the dentin surface, starting at 10 grams (g) 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 participant whether the sensation caused discomfort. The pressure setting at which the participant 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>Week 8</time_frame>
        <population>The ITT (N=85) population included all participants who were randomized received at least one dose of investigational product and had at least one post-baseline efficacy evaluation. This population was based on the treatment to which the participant was randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>Test Product (1.5% KOX, 0 Ppm Fluoride, pH 7)</title>
            <description>Participants rinsed twice daily (morning and evening) with 10 mL of oral rinse (1.5% KOX, 0 ppm fluoride, pH 7) for 60 seconds using standard fluoride dentifrice and then expectorated. No further rinsing with water was allowed after use of the oral rinse. This regimen was performed twice daily for 8 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Negative Control (0.02% w/w Sodium Fluoride)</title>
            <description>Participants rinsed twice daily (morning and evening) with 10 mL of oral rinse (0.02% w/w sodium fluoride) for 60 seconds using standard fluoride dentifrice and then expectorated. No further rinsing with water was allowed after use of the oral rinse. This regimen was performed twice daily for 8 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Placebo (0% KOX, 0 Ppm Fluoride, pH 7)</title>
            <description>Participants rinsed twice daily (morning and evening) with 10 mL of oral rinse (0% KOX, 0 ppm fluoride, pH 7) for 60 seconds using standard fluoride dentifrice and then expectorated. No further rinsing with water was allowed after use of the oral rinse. This regimen was performed twice daily for 8 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Tactile Threshold</title>
          <description>The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed the application of a known force to the dentin surface, starting at 10 grams (g) 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 participant whether the sensation caused discomfort. The pressure setting at which the participant 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 ITT (N=85) population included all participants who were randomized received at least one dose of investigational product and had at least one post-baseline efficacy evaluation. This population was based on the treatment to which the participant was randomized.</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="43"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Tactile threshold at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.35" spread="1.289"/>
                    <measurement group_id="O2" value="10.25" spread="1.118"/>
                    <measurement group_id="O3" value="10.23" spread="1.066"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline at Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.28" spread="22.095"/>
                    <measurement group_id="O2" value="23.75" spread="35.499"/>
                    <measurement group_id="O3" value="11.59" spread="26.788"/>
                  </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>Other</non_inferiority_type>
            <p_value>&lt;0.0004</p_value>
            <p_value_desc>P-value from Van Elteren test</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline tactile threshold as a covariate.</method_desc>
            <param_type>Diference of Least Square mean</param_type>
            <param_value>37.46</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>7.306</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>22.916</ci_lower_limit>
            <ci_upper_limit>51.995</ci_upper_limit>
            <estimate_desc>Difference is the 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>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <p_value_desc>P-value from Van Elteren test</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline tactile threshold as a covariate.</method_desc>
            <param_type>Diference of Least Square mean</param_type>
            <param_value>49.88</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>7.079</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>35.791</ci_lower_limit>
            <ci_upper_limit>63.966</ci_upper_limit>
            <estimate_desc>Difference is the 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>O3</group_id>
            </group_id_list>
            <groups_desc>Test Product versus Combined Control (Placebo and Negative Control) group is obtained by using estimates statement in the ANCOVA model</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <p_value_desc>P-value from Van Elteren test.</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline tactile threshold as a covariate.</method_desc>
            <param_type>Diference of Least Square mean</param_type>
            <param_value>43.67</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>5.862</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>32.001</ci_lower_limit>
            <ci_upper_limit>55.334</ci_upper_limit>
            <estimate_desc>Difference is the first named treatment minus second named treatment such that a positive difference favors the first named treatment.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>8 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Test Product (1.5% KOX, 0 Ppm Fluoride, pH 7)</title>
          <description>Participants rinsed twice daily (morning and evening) with 10 mL of oral rinse (1.5% KOX, 0 ppm] fluoride, pH 7) for 60 seconds using standard fluoride dentifrice and then expectorated. No further rinsing with water was allowed after use of the oral rinse. This regimen was performed twice daily for 8 weeks.</description>
        </group>
        <group group_id="E2">
          <title>Negative Control (0.02% w/w Sodium Fluoride)</title>
          <description>Participants rinsed twice daily (morning and evening) with 10 mL of oral rinse (0.02% w/w sodium fluoride) for 60 seconds using standard fluoride dentifrice and then expectorated. No further rinsing with water was allowed after use of the oral rinse. This regimen was performed twice daily for 8 weeks.</description>
        </group>
        <group group_id="E3">
          <title>Placebo (0% KOX, 0 Ppm Fluoride, pH 7)</title>
          <description>Participants rinsed twice daily (morning and evening) with 10 mL of oral rinse (0% KOX, 0 ppm fluoride, pH 7) for 60 seconds using standard fluoride dentifrice and then expectorated. No further rinsing with water was allowed after use of the oral rinse. This regimen was performed twice daily for 8 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</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="4" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>LIP ULCERATION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>MOUTH ULCERATION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>ORAL DISCOMFORT</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>ORAL MUCOSAL EXFOLIATION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>GASTROENTERITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </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="43"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </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>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03238352
org study id: 207656
nct id: NCT03238352
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
To investigate the efficacy of an experimental oral rinse, containing 1.5% potassium oxalate
      (KOX) and 0 parts per million (ppm) fluoride in relieving dentine hypersensitivity (DH) after
      8 weeks use compared with a placebo oral rinse and a commercialized fluoride oral rinse.
This will be a single centre, eight week, randomized, examiner-blind, three treatment,
      parallel group, stratified study. It will be conducted in healthy participants, with at least
      two sensitive teeth that meet all of the study criteria at the Screening and Baseline visits.
      DH will be assessed at Baseline, and after 4 and 8 weeks twice daily treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Change From Baseline in Schiff Sensitivity Score
time frame: Week 8
description: The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale which was scored as follows - 0: Participant did not respond to air stimulation; 1: Participant responded to air stimulus but does not request discontinuation of stimulus; 2: Participant responded to air stimulus and requested discontinuation or moves from stimulus; 3: Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus. A reduction in Schiff Sensitivity score will be indicative of an improvement in sensitivity.
measure: Change From Baseline in Tactile Threshold
time frame: Week 8
description: The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed the application of a known force to the dentin surface, starting at 10 grams (g) 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 participant whether the sensation caused discomfort. The pressure setting at which the participant 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.
arm group label: Test Product
arm group type: Experimental
description: Participants will rinse twice daily (morning and evening) with 10 milliliters (mL) of oral rinse for 60 timed seconds and expectorate. No further rinsing with water will be permitted after use of the oral rinse.
arm group label: Negative Control
arm group type: Other
description: Participants will rinse twice daily (morning and evening) with 10 mL of oral rinse for 60 timed seconds and expectorate. No further rinsing with water will be permitted after use of the oral rinse.
arm group label: Placebo
arm group type: Placebo Comparator
description: Participants will rinse twice daily (morning and evening) with 10 mL of oral rinse for 60 timed seconds and expectorate. No further rinsing with water will be permitted after use of the oral rinse.
intervention type: Device
intervention name: Potassium oxalate
description: Oral rinse containing 1.5 percent (%) KOX and 0 ppm fluoride
arm group label: Test Product
intervention type: Drug
intervention name: Sodium fluoride
description: Oral rinse containing 0.02% weight by weight (w/w) sodium fluoride (NaF)
arm group label: Negative Control
intervention type: Other
intervention name: Placebo
description: Oral rinse containing 0% KOX and 0 ppm fluoride
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
facility: 
country: United States
responsible party type: Sponsor
mesh term: Dentin Sensitivity
mesh term: Hypersensitivity
mesh term: Listerine
mesh term: Fluorides
mesh term: Sodium Fluoride
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 