<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/NCT02221349</url>
  </required_header>
  <id_info>
    <org_study_id>2014069</org_study_id>
    <nct_id>NCT02221349</nct_id>
  </id_info>
  <brief_title>A Clinical Study of Two Dentinal Hypersensitivity Treatments Used With Normal Oral Hygiene</brief_title>
  <official_title>A Randomized Clinical Study of the Safety and Effectiveness of Two Dentinal Hypersensitivity Treatments Used With Normal Oral Hygiene</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Procter and Gamble</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Procter and Gamble</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will compare the safety and effectiveness of normal oral hygiene with two&#xD;
      different marketed dentifrices, on longer term dentinal hypersensitivity response following&#xD;
      use of potassium oxalate desensitizers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">October 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline Air Challenge</measure>
    <time_frame>60 days</time_frame>
    <description>The Schiff Sensitivity Scale was assessed for each test tooth via an evaporative air challenge. The examiner recorded the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows: 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subjects responds to stimulus and requests discontinuation or moves from stimulus, 3: tooth/subject responds to stimulus considers stimulus to be painful, and requests discontinuation of the stimulus. The higher the Schiff score, the more sensitive the tooth. The mean change from Baseline was calculated for this measure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline Visual Analog Scale</measure>
    <time_frame>60 days</time_frame>
    <description>Visual Analog Scale (VAS) - subjects are asked to look at a VAS and designate the level of hypersensitivity they experienced as a result of the thermal and water challenges using a continuum scale of 0 = No tooth pain up to 100 = Worst tooth pain ever experienced.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Dentin Sensitivity</condition>
  <arm_group>
    <arm_group_label>oxalate liquid &amp; gel plus SnF2 paste</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Stannous fluoride paste, self applied</description>
  </arm_group>
  <arm_group>
    <arm_group_label>oxalate liquid &amp; gel plus NaF paste</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Sodium fluoride paste, self applied</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Potassium oxalate</intervention_name>
    <description>Professionally applied (liquid) and self applied (gel)</description>
    <arm_group_label>oxalate liquid &amp; gel plus NaF paste</arm_group_label>
    <arm_group_label>oxalate liquid &amp; gel plus SnF2 paste</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sodium fluoride paste</intervention_name>
    <description>Toothpaste used by subject</description>
    <arm_group_label>oxalate liquid &amp; gel plus NaF paste</arm_group_label>
    <other_name>NaF paste</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Stannous fluoride paste</intervention_name>
    <description>Toothpaste used by subject</description>
    <arm_group_label>oxalate liquid &amp; gel plus SnF2 paste</arm_group_label>
    <other_name>SnF2 paste</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be at least 18 years of age&#xD;
&#xD;
          -  Provide written informed consent prior to participation and be given a signed copy of&#xD;
             the informed consent form&#xD;
&#xD;
          -  Complete a confidentiality disclosure agreement&#xD;
&#xD;
          -  Be in good general health as determined by the Investigator/designee&#xD;
&#xD;
          -  Have at least one tooth with a Schiff sensitivity score of at least 1 in response to&#xD;
             the air challenge.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Self-reported pregnancy or nursing&#xD;
&#xD;
          -  Severe periodontal disease, as characterized by purulent exudate, generalized&#xD;
             mobility, and/or severe recession&#xD;
&#xD;
          -  Active treatment of periodontitis&#xD;
&#xD;
          -  Fixed facial orthodontic appliances&#xD;
&#xD;
          -  A history of kidney stones&#xD;
&#xD;
          -  Known allergies to the following ingredients; aqua, glycerin, cellulose gum,&#xD;
             dipotassium oxalate, carbomer, sodium hydroxide, sodium benzoate, and potassium&#xD;
             sorbate&#xD;
&#xD;
          -  Any diseases or conditions that might interfere with the safe completion of the study&#xD;
&#xD;
          -  An inability to undergo any study procedures.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chad J Anderson, MS, DMD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chad J Anderson DMD Inc</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chad J Anderson DMD Inc</name>
      <address>
        <city>Fresno</city>
        <state>California</state>
        <zip>93730</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>August 12, 2014</study_first_submitted>
  <study_first_submitted_qc>August 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2014</study_first_posted>
  <results_first_submitted>August 30, 2019</results_first_submitted>
  <results_first_submitted_qc>September 8, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">September 9, 2020</results_first_posted>
  <last_update_submitted>September 8, 2020</last_update_submitted>
  <last_update_submitted_qc>September 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Sensitivity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dentin Sensitivity</mesh_term>
    <mesh_term>Hypersensitivity</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Listerine</mesh_term>
    <mesh_term>Fluorides</mesh_term>
    <mesh_term>Sodium Fluoride</mesh_term>
    <mesh_term>Tin Fluorides</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Oxalate Liquid &amp; Gel Plus SnF2 Paste</title>
          <description>Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Stannous fluoride paste, self applied&#xD;
Potassium oxalate: Professionally applied (liquid) and self applied (gel)&#xD;
Stannous fluoride paste: Toothpaste used by subject</description>
        </group>
        <group group_id="P2">
          <title>Oxalate Liquid &amp; Gel Plus NaF Paste</title>
          <description>Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Sodium fluoride paste, self applied&#xD;
Potassium oxalate: Professionally applied (liquid) and self applied (gel)&#xD;
Sodium fluoride paste: Toothpaste used by subject</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Oxalate Liquid &amp; Gel Plus SnF2 Paste</title>
          <description>Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Stannous fluoride paste, self applied&#xD;
Potassium oxalate: Professionally applied (liquid) and self applied (gel)&#xD;
Stannous fluoride paste: Toothpaste used by subject</description>
        </group>
        <group group_id="B2">
          <title>Oxalate Liquid &amp; Gel Plus NaF Paste</title>
          <description>Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Sodium fluoride paste, self applied&#xD;
Potassium oxalate: Professionally applied (liquid) and self applied (gel)&#xD;
Sodium fluoride paste: Toothpaste used by subject</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="15"/>
            <count group_id="B2" value="15"/>
            <count group_id="B3" value="30"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <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="41.5" spread="10.97"/>
                    <measurement group_id="B2" value="44.9" spread="12.52"/>
                    <measurement group_id="B3" value="43.2" spread="11.69"/>
                  </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="14"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Hispanic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>American Indian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian Oriental</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Caucasian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Multi-Racial</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline Air Challenge</title>
        <description>The Schiff Sensitivity Scale was assessed for each test tooth via an evaporative air challenge. The examiner recorded the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows: 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subjects responds to stimulus and requests discontinuation or moves from stimulus, 3: tooth/subject responds to stimulus considers stimulus to be painful, and requests discontinuation of the stimulus. The higher the Schiff score, the more sensitive the tooth. The mean change from Baseline was calculated for this measure.</description>
        <time_frame>60 days</time_frame>
        <population>Thirty (30) subjects received study products and were measured at the Baseline visit. Twenty-Nine (29) subjects completed the study thus, one subject dropped from the study prior to Day 60 and was not analyzed for the 60 day measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Oxalate Liquid &amp; Gel Plus SnF2 Paste</title>
            <description>Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Stannous fluoride paste, self applied&#xD;
Potassium oxalate: Professionally applied (liquid) and self applied (gel)&#xD;
Stannous fluoride paste: Toothpaste used by subject</description>
          </group>
          <group group_id="O2">
            <title>Oxalate Liquid &amp; Gel Plus NaF Paste</title>
            <description>Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Sodium fluoride paste, self applied&#xD;
Potassium oxalate: Professionally applied (liquid) and self applied (gel)&#xD;
Sodium fluoride paste: Toothpaste used by subject</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline Air Challenge</title>
          <description>The Schiff Sensitivity Scale was assessed for each test tooth via an evaporative air challenge. The examiner recorded the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows: 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subjects responds to stimulus and requests discontinuation or moves from stimulus, 3: tooth/subject responds to stimulus considers stimulus to be painful, and requests discontinuation of the stimulus. The higher the Schiff score, the more sensitive the tooth. The mean change from Baseline was calculated for this measure.</description>
          <population>Thirty (30) subjects received study products and were measured at the Baseline visit. Twenty-Nine (29) subjects completed the study thus, one subject dropped from the study prior to Day 60 and was not analyzed for the 60 day measure.</population>
          <units>Units on a 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="14"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.643" spread="0.770"/>
                    <measurement group_id="O2" value="-1.500" spread="0.906"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline Visual Analog Scale</title>
        <description>Visual Analog Scale (VAS) - subjects are asked to look at a VAS and designate the level of hypersensitivity they experienced as a result of the thermal and water challenges using a continuum scale of 0 = No tooth pain up to 100 = Worst tooth pain ever experienced.</description>
        <time_frame>60 days</time_frame>
        <population>Thirty (30) subjects received study products. Twenty-Nine (29) subjects completed the study thus, one subject dropped from the study prior to Day 60 and was not analyzed for the 60 day measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Oxalate Liquid &amp; Gel Plus SnF2 Paste</title>
            <description>Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Stannous fluoride paste, self applied&#xD;
Potassium oxalate: Professionally applied (liquid) and self applied (gel)&#xD;
Stannous fluoride paste: Toothpaste used by subject</description>
          </group>
          <group group_id="O2">
            <title>Oxalate Liquid &amp; Gel Plus NaF Paste</title>
            <description>Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Sodium fluoride paste, self applied&#xD;
Potassium oxalate: Professionally applied (liquid) and self applied (gel)&#xD;
Sodium fluoride paste: Toothpaste used by subject</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline Visual Analog Scale</title>
          <description>Visual Analog Scale (VAS) - subjects are asked to look at a VAS and designate the level of hypersensitivity they experienced as a result of the thermal and water challenges using a continuum scale of 0 = No tooth pain up to 100 = Worst tooth pain ever experienced.</description>
          <population>Thirty (30) subjects received study products. Twenty-Nine (29) subjects completed the study thus, one subject dropped from the study prior to Day 60 and was not analyzed for the 60 day measure.</population>
          <units>Units on a 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="14"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-29.82" spread="18.65"/>
                    <measurement group_id="O2" value="-24.67" spread="26.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Oxalate Liquid &amp; Gel Plus SnF2 Paste</title>
          <description>Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Stannous fluoride paste, self applied&#xD;
Potassium oxalate: Professionally applied (liquid) and self applied (gel)&#xD;
Stannous fluoride paste: Toothpaste used by subject</description>
        </group>
        <group group_id="E2">
          <title>Oxalate Liquid &amp; Gel Plus NaF Paste</title>
          <description>Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Sodium fluoride paste, self applied&#xD;
Potassium oxalate: Professionally applied (liquid) and self applied (gel)&#xD;
Sodium fluoride paste: Toothpaste used by subject</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="1" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>COSTART</default_vocab>
        <default_assessment>Non-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="1" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperesthesia</sub_title>
                <description>Burning and painful mouth</description>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>PAIN</sub_title>
                <description>Painful mouth, mild and possibly related</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Trial Manager</name_or_title>
      <organization>The Procter &amp; Gamble Company</organization>
      <phone>513-622-2489</phone>
      <email>peters.j.2@pg.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/NCT02221349
org study id: 2014069
nct id: NCT02221349
lead sponsor: 
has dmc: No
This study will compare the safety and effectiveness of normal oral hygiene with two
      different marketed dentifrices, on longer term dentinal hypersensitivity response following
      use of potassium oxalate desensitizers.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change From Baseline Air Challenge
time frame: 60 days
description: The Schiff Sensitivity Scale was assessed for each test tooth via an evaporative air challenge. The examiner recorded the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows: 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subjects responds to stimulus and requests discontinuation or moves from stimulus, 3: tooth/subject responds to stimulus considers stimulus to be painful, and requests discontinuation of the stimulus. The higher the Schiff score, the more sensitive the tooth. The mean change from Baseline was calculated for this measure.
measure: Change From Baseline Visual Analog Scale
time frame: 60 days
description: Visual Analog Scale (VAS) - subjects are asked to look at a VAS and designate the level of hypersensitivity they experienced as a result of the thermal and water challenges using a continuum scale of 0 = No tooth pain up to 100 = Worst tooth pain ever experienced.
arm group label: oxalate liquid & gel plus SnF2 paste
arm group type: Other
description: Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Stannous fluoride paste, self applied
arm group label: oxalate liquid & gel plus NaF paste
arm group type: Other
description: Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Sodium fluoride paste, self applied
intervention type: Device
intervention name: Potassium oxalate
description: Professionally applied (liquid) and self applied (gel)
arm group label: oxalate liquid & gel plus NaF paste
arm group label: oxalate liquid & gel plus SnF2 paste
intervention type: Drug
intervention name: Sodium fluoride paste
description: Toothpaste used by subject
arm group label: oxalate liquid & gel plus NaF paste
other name: NaF paste
intervention type: Drug
intervention name: Stannous fluoride paste
description: Toothpaste used by subject
arm group label: oxalate liquid & gel plus SnF2 paste
other name: SnF2 paste
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Chad J Anderson, MS, DMD
role: Principal Investigator
affiliation: Chad J Anderson DMD Inc
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
mesh term: Tin Fluorides
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 