<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/NCT02189382</url>
  </required_header>
  <id_info>
    <org_study_id>2014029</org_study_id>
    <nct_id>NCT02189382</nct_id>
  </id_info>
  <brief_title>Evaluation of the Safety and Efficacy of an Oxalate Gel or Negative Control on Dentinal Hypersensitivity</brief_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>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will compare the safety and effectiveness of a potassium oxalate desensitizer or&#xD;
      negative control on dentinal hypersensitivity.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">July 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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline Air Challenge</measure>
    <time_frame>30 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/subject responds to stimulus and requests discontinuation or moves form 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 in Tactile Threshold</measure>
    <time_frame>30 days</time_frame>
    <description>Tactile Threshold was measured using a Yeaple probe. Testing was performed beginning at 10 g. The examiner recorded tactile scores for responding teeth. After treatment, testing began at 10 g and increase by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increased until a &quot;yes&quot; response was repeated. If a second &quot;yes&quot; was not obtained, the force setting was increased to the next step and continued until a force was found which elicited two consecutive &quot;yes&quot; responses and was recorded as the threshold on the Tactile Sensitivity Score form. The mean change from Baseline was calculated for this measure.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Dentin Sensitivity</condition>
  <arm_group>
    <arm_group_label>Potassium Oxalate Gel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Self Applied</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Water</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Self Applied</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Potassium Oxalate</intervention_name>
    <arm_group_label>Potassium Oxalate Gel</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Water</intervention_name>
    <arm_group_label>Water</arm_group_label>
  </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;
          -  agree not to participate in any other oral/dental product studies during the course of&#xD;
             this study;&#xD;
&#xD;
          -  agree to delay any dentistry (including dental prophylaxis) until the study has been&#xD;
             completed;&#xD;
&#xD;
          -  agree to refrain from the use of any non-study oral hygiene products;&#xD;
&#xD;
          -  agree to return for all scheduled visits and follow study procedures; and.&#xD;
&#xD;
          -  have at least one tooth with a Schiff sensitivity score of at least 1 in response to&#xD;
             air challenge and a Yeaple Probe score of 10-40 in response to tactile 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;
             or&#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>
  <location>
    <facility>
      <name>Silverstone Research Group</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89146</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>July 8, 2014</study_first_submitted>
  <study_first_submitted_qc>July 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 14, 2014</study_first_posted>
  <results_first_submitted>May 9, 2018</results_first_submitted>
  <results_first_submitted_qc>July 20, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">August 20, 2018</results_first_posted>
  <last_update_submitted>July 20, 2018</last_update_submitted>
  <last_update_submitted_qc>July 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 20, 2018</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>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Potassium Oxalate Gel</title>
          <description>Self Applied&#xD;
Potassium Oxalate</description>
        </group>
        <group group_id="P2">
          <title>Water</title>
          <description>Self Applied&#xD;
Water</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
                <participants group_id="P2" count="35"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
                <participants group_id="P2" count="35"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Potassium Oxalate Gel</title>
          <description>Self Applied&#xD;
Potassium Oxalate</description>
        </group>
        <group group_id="B2">
          <title>Water</title>
          <description>Self Applied&#xD;
Water</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="35"/>
            <count group_id="B2" value="35"/>
            <count group_id="B3" value="70"/>
          </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="34.5" spread="11.13"/>
                    <measurement group_id="B2" value="36.6" spread="14.25"/>
                    <measurement group_id="B3" value="35.6" spread="12.74"/>
                  </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="20"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="28"/>
                  </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>Ethnicity</title>
              <category_list>
                <category>
                  <title>Asian Indian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian Oriental</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Caucasian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Hispanic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Multi-Racial</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </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/subject responds to stimulus and requests discontinuation or moves form 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>30 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Potassium Oxalate Gel</title>
            <description>Self Applied&#xD;
Potassium Oxalate</description>
          </group>
          <group group_id="O2">
            <title>Water</title>
            <description>Self Applied&#xD;
Water</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/subject responds to stimulus and requests discontinuation or moves form 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>
          <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="35"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.200" spread="0.677"/>
                    <measurement group_id="O2" value="-0.086" spread="0.284"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Tactile Threshold</title>
        <description>Tactile Threshold was measured using a Yeaple probe. Testing was performed beginning at 10 g. The examiner recorded tactile scores for responding teeth. After treatment, testing began at 10 g and increase by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increased until a &quot;yes&quot; response was repeated. If a second &quot;yes&quot; was not obtained, the force setting was increased to the next step and continued until a force was found which elicited two consecutive &quot;yes&quot; responses and was recorded as the threshold on the Tactile Sensitivity Score form. The mean change from Baseline was calculated for this measure.</description>
        <time_frame>30 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Potassium Oxalate Gel</title>
            <description>Self Applied&#xD;
Potassium Oxalate</description>
          </group>
          <group group_id="O2">
            <title>Water</title>
            <description>Self Applied&#xD;
Water</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Tactile Threshold</title>
          <description>Tactile Threshold was measured using a Yeaple probe. Testing was performed beginning at 10 g. The examiner recorded tactile scores for responding teeth. After treatment, testing began at 10 g and increase by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increased until a &quot;yes&quot; response was repeated. If a second &quot;yes&quot; was not obtained, the force setting was increased to the next step and continued until a force was found which elicited two consecutive &quot;yes&quot; responses and was recorded as the threshold on the Tactile Sensitivity Score form. The mean change from Baseline was calculated for this measure.</description>
          <units>Grams (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="35"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.857" spread="12.312"/>
                    <measurement group_id="O2" value="0.286" spread="2.956"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>30 Days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Potassium Oxalate Gel</title>
          <description>Self Applied&#xD;
Potassium Oxalate</description>
        </group>
        <group group_id="E2">
          <title>Water</title>
          <description>Self Applied&#xD;
Water</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="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="35"/>
              </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>Written consent from sponsor.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Trial Manager</name_or_title>
      <organization>Procter and Gamble</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/NCT02189382
org study id: 2014029
nct id: NCT02189382
lead sponsor: 
has dmc: Yes
This study will compare the safety and effectiveness of a potassium oxalate desensitizer or
      negative control on dentinal hypersensitivity.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Change From Baseline Air Challenge
time frame: 30 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/subject responds to stimulus and requests discontinuation or moves form 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 in Tactile Threshold
time frame: 30 days
description: Tactile Threshold was measured using a Yeaple probe. Testing was performed beginning at 10 g. The examiner recorded tactile scores for responding teeth. After treatment, testing began at 10 g and increase by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increased until a "yes" response was repeated. If a second "yes" was not obtained, the force setting was increased to the next step and continued until a force was found which elicited two consecutive "yes" responses and was recorded as the threshold on the Tactile Sensitivity Score form. The mean change from Baseline was calculated for this measure.
arm group label: Potassium Oxalate Gel
arm group type: Experimental
description: Self Applied
arm group label: Water
arm group type: Other
description: Self Applied
intervention type: Device
intervention name: Potassium Oxalate
arm group label: Potassium Oxalate Gel
intervention type: Other
intervention name: Water
arm group label: Water
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Dentin Sensitivity
mesh term: Hypersensitivity
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 