<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/NCT01669785</url>
  </required_header>
  <id_info>
    <org_study_id>CTP-002</org_study_id>
    <nct_id>NCT01669785</nct_id>
  </id_info>
  <brief_title>NUPRO Sensodyne Prophylaxis Paste With NovaMin Sensitivity Relief Study</brief_title>
  <official_title>NUPRO Sensodyne Prophylaxis Paste With NovaMin for the Treatment of Dentin Hypersensitivity.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dentsply International</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dentsply Sirona Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is intended to verify through clinical measurement that the NUPRO Sensodyne&#xD;
      Prophylaxis Paste with Novamin provides immediate sensitivity relief as well as extended&#xD;
      relief up to 28 days.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It is hypothesized that the prophy paste with Novamin will give patients immediate&#xD;
      sensitivity relief, as well as sensitivity relief up to 4 weeks (28 days) after measurement.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2012</start_date>
  <completion_date type="Actual">May 2012</completion_date>
  <primary_completion_date type="Actual">April 2012</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Baseline Pre-Prophy Assessment (Tactile Sensitivity)</measure>
    <time_frame>Pre-treatment measurement</time_frame>
    <description>Pre-prophy procedure baseline assessment is measured with an electronic force sensing probe (Yeaple probe). Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. 10,20,30,40, up to 50 grams of force are applied to the hypersensitive tooth until pain is elicited. The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitiv&#xD;
Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Immediate Sensitivity Relief (Tactile Sensitivity)</measure>
    <time_frame>Immediately after treatment .</time_frame>
    <description>Assessment of sensitivity score via tactile and air blast measurements immediately after treatment. Tactile hypersensitivity is measured with an electronic force sensing probel (Yeaple probe). Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. 10, 20, 30, 40 up to 50 grams of force are applied to the hypersensitive tooth until pain is elicited. The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitivity.&#xD;
Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Long-term Sensitivity Relief (Tactile Sensitivity)</measure>
    <time_frame>28 days (+/- 2 days) post treatment.</time_frame>
    <description>Assessment of sensitivity score via tactile measurements long term after treatment.&#xD;
Tactile hypersensitivity is measured with an electronic force sensing probel (Yeaple probe). Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. 10 to 50 grams of force are applied to the hypersensitive tooth until pain is elicited. The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitivity.&#xD;
Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Baseline Pre-Prophy Assessment (Air Blast Sensitivity)</measure>
    <time_frame>Pre-treatment measurement</time_frame>
    <description>Pre-prophy procedure baseline assessment using Schiff Cold Air Sensitivity scale (0-3).&#xD;
Air blast hypersensitivity is measured using the Schiff Cold Air Sensitivty scale (0-3). The scale is scored as follows:&#xD;
0=Subject does not respond to stimulus; 1= Subject responds to stimulus but does not request discontinuation of stimulus; 2=Subject responds to stimulus and requests discontinuation or moves from air stimulus; 3=Subject responds to stimulus, considers it painful and requests discontinuation.&#xD;
The higher the score, the higher the hypersensitivity.&#xD;
Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Immediate Sensitivity Relief (Schiff Air Blast Sensitivity)</measure>
    <time_frame>Immediately after treatment .</time_frame>
    <description>Assessment of sensitivity score via air blast measurements immediately after treatment.&#xD;
Air blast hypersensitivity is measured using the Schiff Cold Air Sensitivity scale (0-3). The scale is scored as follows:&#xD;
0=Subject does not respond to stimulus; 1= Subject responds to stimulus but does not request discontinuation of stimulus; 2=Subject responds to stimulus and requests discontinuation or moves from air stimulus; 3=Subject responds to stimulus, considers it painful and requests discontinuation.&#xD;
Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Long-term Sensitivity Relief (Schiff Air Blast Sensitivity)</measure>
    <time_frame>28 days (+/- 2 days) post treatment.</time_frame>
    <description>Assessment of sensitivity score Schiff air blast measurements long term after treatment.&#xD;
Air blast hypersensitivity is measured using the Schiff Cold Air Sensitivity scale (0-3). The scale is scored as follows:&#xD;
0=Subject does not respond to stimulus; 1= Subject responds to stimulus but does not request discontinuation of stimulus; 2=Subject responds to stimulus and requests discontinuation or moves from air stimulus; 3=Subject responds to stimulus, considers it painful and requests discontinuation.&#xD;
Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sensitivity Relief (Self-Assessment)</measure>
    <time_frame>Pre-Treatment</time_frame>
    <description>All subjects completed a questionnaire titled &quot;How sensitive are your teeth?&quot; to assess their whole-mouth tooth sensitivity prior to the baseline assessments.&#xD;
The questionnaire contained a 4-item verbal descriptor scale as follows:&#xD;
Score 0= no discomfort or awareness of sensitivity; 1=mild discomfort/pain from sensitive teeth; 2=moderate discomfort/pain from sensitive teeth; 3=severe pain from sensitive teeth.&#xD;
The higher the score, the higher the hypersensitivity.&#xD;
Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post- Scaling Sensitivity Relief (Self-Assessment)</measure>
    <time_frame>Post-scaling procedure,immediate</time_frame>
    <description>All subjects completed a questionnaire titled &quot;How sensitive are your teeth?&quot; to assess their whole-mouth tooth sensitivity immediately following the scaling procedure.&#xD;
The questionnaire contained a 4-item verbal descriptor scale as follows:&#xD;
Score 0= no discomfort or awareness of sensitivity; 1=mild discomfort/pain from sensitive teeth; 2=moderate discomfort/pain from sensitive teeth; 3=severe pain from sensitive teeth.&#xD;
The higher the score, the higher the hypersensitivity.&#xD;
Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-prophylaxis Sensitivity Relief (Self-Assessment)</measure>
    <time_frame>Immediately following post-prophylaxis treatment.</time_frame>
    <description>All subjects completed a questionnaire titled &quot;How sensitive are your teeth?&quot; to assess their whole-mouth tooth sensitivity immediately following the timed, 1-minute prophylaxis paste application.&#xD;
The questionnaire contained a 4-item verbal descriptor scale as follows:&#xD;
Score 0= no discomfort or awareness of sensitivity; 1=mild discomfort/pain from sensitive teeth;2=moderate discomfort/pain from sensitive teeth; 3=severe pain from sensitive teeth.&#xD;
The higher the score, the higher the hypersensitivity.&#xD;
Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Long-term Sensitivity Relief (Self-Assessment)</measure>
    <time_frame>28 days post-prophylaxis treatment.</time_frame>
    <description>All subjects completed a questionnaire titled &quot;How sensitive are your teeth?&quot; to assess their whole-mouth tooth sensitivity 28 days following prophylaxis treatment.&#xD;
The questionnaire contained a 4-item verbal descriptor scale as follows:&#xD;
Score 0= no discomfort or awareness of sensitivity;1=mild discomfort/pain from sensitive teeth; 2=moderate discomfort/pain from sensitive teeth; 3=severe pain from sensitive teeth.&#xD;
The higher the score, the higher the hypersensitivity.&#xD;
Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">139</enrollment>
  <condition>Tooth Hypersensitivity</condition>
  <arm_group>
    <arm_group_label>Group C</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>NUPRO Classic Prophy Paste&#xD;
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride..&#xD;
Leave in contact for 60 seconds, rinse with water and expectorate.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>NUPRO Sensodyne Prophy Paste w/ Novamin&#xD;
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride.&#xD;
Leave in contact for 60 seconds, rinse with water and expectorate</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride&#xD;
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.&#xD;
Leave in contact for 60 seconds, rinse with water and expectorate.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Group C</intervention_name>
    <description>Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.</description>
    <arm_group_label>Group C</arm_group_label>
    <other_name>NUPRO Classic Prophy Paste</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Group A</intervention_name>
    <description>Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.</description>
    <arm_group_label>Group B</arm_group_label>
    <other_name>NUPRO Sensodyne Prophy Paste with NovaMin with Fluoride.</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Group B</intervention_name>
    <description>Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.</description>
    <arm_group_label>Group A</arm_group_label>
    <other_name>NUPRO Sensodyne Prophy Paste with NovaMin without Fluoride.</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Availability to complete in the 28 day duration.&#xD;
&#xD;
          -  Two sensitive teeth, which are not adjacent to each other and preferably in different&#xD;
             quadrants, which demonstrate cervical erosion, abrasion and gingival recession.&#xD;
&#xD;
          -  Qualifying response to tactile stimuli as defined by a score of &lt;/= 20 grams.&#xD;
&#xD;
          -  Qualifying response to air blast stimuli as defined by a score of &gt;/= 1 on the Schiff&#xD;
             Cold Air Sensitivity Scale.&#xD;
&#xD;
          -  Subjects need to satisfy the qualifying response to stimuli for both parameters&#xD;
             assesses (Tactile or Air Blast) on at least two teeth (non-adjacent) to be entered&#xD;
             into the study.&#xD;
&#xD;
          -  Good general health with no known allergies to products being tested.&#xD;
&#xD;
          -  Use of a non-desensitizing dentifrice for 2 weeks prior to entry into the study.&#xD;
&#xD;
          -  Subjects must have a minimum of 10 natural teeth, excluding 3rd molars.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals who exhibit gross oral pathology.&#xD;
&#xD;
          -  Females who may be pregnant or lactating or intending to become pregnant.&#xD;
&#xD;
          -  Individuals who require anesthetic during scaling.&#xD;
&#xD;
          -  Dental pathology which may cause pain similar to tooth sensitivity.&#xD;
&#xD;
          -  Individuals with large amounts of calculus.&#xD;
&#xD;
          -  Subjects with active infectious diseases such as hepatitis, HIV, or tuberculosis.&#xD;
&#xD;
          -  Any condition requiring antibiotic prophylaxis for dental treatment.&#xD;
&#xD;
          -  Excessive gingival inflammation.&#xD;
&#xD;
          -  Individuals who had their teeth cleaned within 30 days of the screening appointment.&#xD;
&#xD;
          -  Individuals who have had desensitizing treatment or tooth bleaching within 90 days of&#xD;
             screening appointment.&#xD;
&#xD;
          -  Oral pathology, chronic disease, or history of allergy to test products.&#xD;
&#xD;
          -  Advanced periodontal disease or treatment for periodontal disease (including surgery)&#xD;
             within the past twelve months.&#xD;
&#xD;
          -  Sensitive teeth with mobility greater than one.&#xD;
&#xD;
          -  Teeth with extensive/defective restorations (including prosthetic crowns), suspected&#xD;
             pulpitis, caries, cracked enamel, or used as abutments for removable partial dentures.&#xD;
&#xD;
          -  Regular use of sedatives, anti-inflammatory drugs, or analgesic.&#xD;
&#xD;
          -  Participation in a desensitizing dentifrice study or regular use of a desensitizing&#xD;
             dentifrice within the past 4 weeks.&#xD;
&#xD;
          -  Current participation in any other clinical study or receipt of an investigational&#xD;
             drug within 30 days of the screening visit at the start of the study.&#xD;
&#xD;
          -  Personnel; a) an employee of the sponsor; b0 A member or relative of teh study site&#xD;
             staff directly involved with the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeffrey L Milleman, DDS, MPA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Salus Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Salus Research, Inc.</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>August 2014</verification_date>
  <study_first_submitted>June 8, 2012</study_first_submitted>
  <study_first_submitted_qc>August 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2012</study_first_posted>
  <results_first_submitted>February 20, 2014</results_first_submitted>
  <results_first_submitted_qc>August 20, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">August 21, 2014</results_first_posted>
  <last_update_submitted>August 20, 2014</last_update_submitted>
  <last_update_submitted_qc>August 20, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 21, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dentin Sensitivity</mesh_term>
    <mesh_term>Hypersensitivity</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Listerine</mesh_term>
    <mesh_term>Fluorides</mesh_term>
    <mesh_term>Sodium Fluoride</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Group A</title>
          <description>NUPRO Sensodyne Prophy Paste w/ Novamin&#xD;
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride.&#xD;
Leave in contact for 60 seconds, rinse with water and expectorate.</description>
        </group>
        <group group_id="P2">
          <title>Group B</title>
          <description>NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride&#xD;
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.&#xD;
Leave in contact for 60 seconds, rinse with water and expectorate.</description>
        </group>
        <group group_id="P3">
          <title>Group C</title>
          <description>NUPRO Classic Prophy Paste&#xD;
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride..&#xD;
Leave in contact for 60 seconds, rinse with water and expectorate.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="45"/>
                <participants group_id="P2" count="48"/>
                <participants group_id="P3" count="46"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="45"/>
                <participants group_id="P2" count="48"/>
                <participants group_id="P3" count="46"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Group A</title>
          <description>NUPRO Sensodyne Prophy Paste w/ Novamin. Administered on day one only.Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride.&#xD;
Leave in contact for 60 seconds, rinse with water and expectorate.</description>
        </group>
        <group group_id="B2">
          <title>Group B</title>
          <description>NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride.Administered on day one only.Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.&#xD;
Leave in contact for 60 seconds, rinse with water and expectorate.</description>
        </group>
        <group group_id="B3">
          <title>Group C</title>
          <description>NUPRO Classic Prophy Paste.Administered on day one only.Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride.Leave in contact for 60 seconds, rinse with water and expectorate.</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="45"/>
            <count group_id="B2" value="48"/>
            <count group_id="B3" value="46"/>
            <count group_id="B4" value="139"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>mean years of age</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="44" spread="11.18274"/>
                    <measurement group_id="B2" value="41" spread="11.21829"/>
                    <measurement group_id="B3" value="43" spread="10.928"/>
                    <measurement group_id="B4" value="43" spread="11.10967"/>
                  </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="36"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="35"/>
                    <measurement group_id="B4" value="110"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                    <measurement group_id="B2" value="48"/>
                    <measurement group_id="B3" value="46"/>
                    <measurement group_id="B4" value="139"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Baseline Pre-Prophy Assessment (Tactile Sensitivity)</title>
        <description>Pre-prophy procedure baseline assessment is measured with an electronic force sensing probe (Yeaple probe). Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. 10,20,30,40, up to 50 grams of force are applied to the hypersensitive tooth until pain is elicited. The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitiv&#xD;
Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.</description>
        <time_frame>Pre-treatment measurement</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>NUPRO Sensodyne Prophy Paste w/ Novamin&#xD;
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride.&#xD;
Leave in contact for 60 seconds, rinse with water and expectorate.</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride&#xD;
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.&#xD;
Leave in contact for 60 seconds, rinse with water and expectorate.</description>
          </group>
          <group group_id="O3">
            <title>Group C</title>
            <description>NUPRO Classic Prophy Paste&#xD;
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride..&#xD;
Leave in contact for 60 seconds, rinse with water and expectorate.</description>
          </group>
        </group_list>
        <measure>
          <title>Baseline Pre-Prophy Assessment (Tactile Sensitivity)</title>
          <description>Pre-prophy procedure baseline assessment is measured with an electronic force sensing probe (Yeaple probe). Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. 10,20,30,40, up to 50 grams of force are applied to the hypersensitive tooth until pain is elicited. The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitiv&#xD;
Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.</description>
          <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="45"/>
                <count group_id="O2" value="48"/>
                <count group_id="O3" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.56" spread="1.59"/>
                    <measurement group_id="O2" value="10.00" spread="0.00"/>
                    <measurement group_id="O3" value="10.98" spread="2.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Immediate Sensitivity Relief (Tactile Sensitivity)</title>
        <description>Assessment of sensitivity score via tactile and air blast measurements immediately after treatment. Tactile hypersensitivity is measured with an electronic force sensing probel (Yeaple probe). Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. 10, 20, 30, 40 up to 50 grams of force are applied to the hypersensitive tooth until pain is elicited. The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitivity.&#xD;
Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.</description>
        <time_frame>Immediately after treatment .</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride&#xD;
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.&#xD;
Leave in contact for 60 seconds, rinse with water and expectorate.</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride&#xD;
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.&#xD;
Leave in contact for 60 seconds, rinse with water and expectorate.</description>
          </group>
          <group group_id="O3">
            <title>Group C</title>
            <description>NUPRO Classic Prophy Paste&#xD;
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride..&#xD;
Leave in contact for 60 seconds, rinse with water and expectorate.</description>
          </group>
        </group_list>
        <measure>
          <title>Immediate Sensitivity Relief (Tactile Sensitivity)</title>
          <description>Assessment of sensitivity score via tactile and air blast measurements immediately after treatment. Tactile hypersensitivity is measured with an electronic force sensing probel (Yeaple probe). Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. 10, 20, 30, 40 up to 50 grams of force are applied to the hypersensitive tooth until pain is elicited. The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitivity.&#xD;
Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.</description>
          <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="45"/>
                <count group_id="O2" value="48"/>
                <count group_id="O3" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.61" spread="11.31"/>
                    <measurement group_id="O2" value="16.67" spread="9.01"/>
                    <measurement group_id="O3" value="12.01" spread="5.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Long-term Sensitivity Relief (Tactile Sensitivity)</title>
        <description>Assessment of sensitivity score via tactile measurements long term after treatment.&#xD;
Tactile hypersensitivity is measured with an electronic force sensing probel (Yeaple probe). Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. 10 to 50 grams of force are applied to the hypersensitive tooth until pain is elicited. The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitivity.&#xD;
Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.</description>
        <time_frame>28 days (+/- 2 days) post treatment.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>NUPRO Sensodyne Prophy Paste w/ Novamin&#xD;
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride.&#xD;
Leave in contact for 60 seconds, rinse with water and expectorate.</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride&#xD;
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.&#xD;
Leave in contact for 60 seconds, rinse with water and expectorate.</description>
          </group>
          <group group_id="O3">
            <title>Group C</title>
            <description>NUPRO Classic Prophy Paste&#xD;
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride..&#xD;
Leave in contact for 60 seconds, rinse with water and expectorate.</description>
          </group>
        </group_list>
        <measure>
          <title>Long-term Sensitivity Relief (Tactile Sensitivity)</title>
          <description>Assessment of sensitivity score via tactile measurements long term after treatment.&#xD;
Tactile hypersensitivity is measured with an electronic force sensing probel (Yeaple probe). Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. 10 to 50 grams of force are applied to the hypersensitive tooth until pain is elicited. The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitivity.&#xD;
Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.</description>
          <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="45"/>
                <count group_id="O2" value="48"/>
                <count group_id="O3" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.89" spread="11.46"/>
                    <measurement group_id="O2" value="16.51" spread="10.35"/>
                    <measurement group_id="O3" value="12.07" spread="5.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sensitivity Relief (Self-Assessment)</title>
        <description>All subjects completed a questionnaire titled &quot;How sensitive are your teeth?&quot; to assess their whole-mouth tooth sensitivity prior to the baseline assessments.&#xD;
The questionnaire contained a 4-item verbal descriptor scale as follows:&#xD;
Score 0= no discomfort or awareness of sensitivity; 1=mild discomfort/pain from sensitive teeth; 2=moderate discomfort/pain from sensitive teeth; 3=severe pain from sensitive teeth.&#xD;
The higher the score, the higher the hypersensitivity.&#xD;
Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.</description>
        <time_frame>Pre-Treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>NUPRO Sensodyne Prophy Paste w/ Novamin&#xD;
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride.&#xD;
Leave in contact for 60 seconds, rinse with water and expectorate.</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride&#xD;
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.&#xD;
Leave in contact for 60 seconds, rinse with water and expectorate.</description>
          </group>
          <group group_id="O3">
            <title>Group C</title>
            <description>NUPRO Classic Prophy Paste&#xD;
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride..&#xD;
Leave in contact for 60 seconds, rinse with water and expectorate.</description>
          </group>
        </group_list>
        <measure>
          <title>Sensitivity Relief (Self-Assessment)</title>
          <description>All subjects completed a questionnaire titled &quot;How sensitive are your teeth?&quot; to assess their whole-mouth tooth sensitivity prior to the baseline assessments.&#xD;
The questionnaire contained a 4-item verbal descriptor scale as follows:&#xD;
Score 0= no discomfort or awareness of sensitivity; 1=mild discomfort/pain from sensitive teeth; 2=moderate discomfort/pain from sensitive teeth; 3=severe pain from sensitive teeth.&#xD;
The higher the score, the higher the hypersensitivity.&#xD;
Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.</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="45"/>
                <count group_id="O2" value="48"/>
                <count group_id="O3" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.82" spread="0.72"/>
                    <measurement group_id="O2" value="0.67" spread="0.75"/>
                    <measurement group_id="O3" value="0.76" spread="0.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Baseline Pre-Prophy Assessment (Air Blast Sensitivity)</title>
        <description>Pre-prophy procedure baseline assessment using Schiff Cold Air Sensitivity scale (0-3).&#xD;
Air blast hypersensitivity is measured using the Schiff Cold Air Sensitivty scale (0-3). The scale is scored as follows:&#xD;
0=Subject does not respond to stimulus; 1= Subject responds to stimulus but does not request discontinuation of stimulus; 2=Subject responds to stimulus and requests discontinuation or moves from air stimulus; 3=Subject responds to stimulus, considers it painful and requests discontinuation.&#xD;
The higher the score, the higher the hypersensitivity.&#xD;
Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.</description>
        <time_frame>Pre-treatment measurement</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>NUPRO Sensodyne Prophy Paste w/ Novamin&#xD;
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride.&#xD;
Leave in contact for 60 seconds, rinse with water and expectorate.</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride&#xD;
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.&#xD;
Leave in contact for 60 seconds, rinse with water and expectorate.</description>
          </group>
          <group group_id="O3">
            <title>Group C</title>
            <description>NUPRO Classic Prophy Paste&#xD;
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride..&#xD;
Leave in contact for 60 seconds, rinse with water and expectorate.</description>
          </group>
        </group_list>
        <measure>
          <title>Baseline Pre-Prophy Assessment (Air Blast Sensitivity)</title>
          <description>Pre-prophy procedure baseline assessment using Schiff Cold Air Sensitivity scale (0-3).&#xD;
Air blast hypersensitivity is measured using the Schiff Cold Air Sensitivty scale (0-3). The scale is scored as follows:&#xD;
0=Subject does not respond to stimulus; 1= Subject responds to stimulus but does not request discontinuation of stimulus; 2=Subject responds to stimulus and requests discontinuation or moves from air stimulus; 3=Subject responds to stimulus, considers it painful and requests discontinuation.&#xD;
The higher the score, the higher the hypersensitivity.&#xD;
Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.</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="45"/>
                <count group_id="O2" value="48"/>
                <count group_id="O3" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.72" spread="0.58"/>
                    <measurement group_id="O2" value="1.70" spread="0.58"/>
                    <measurement group_id="O3" value="1.65" spread="0.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Immediate Sensitivity Relief (Schiff Air Blast Sensitivity)</title>
        <description>Assessment of sensitivity score via air blast measurements immediately after treatment.&#xD;
Air blast hypersensitivity is measured using the Schiff Cold Air Sensitivity scale (0-3). The scale is scored as follows:&#xD;
0=Subject does not respond to stimulus; 1= Subject responds to stimulus but does not request discontinuation of stimulus; 2=Subject responds to stimulus and requests discontinuation or moves from air stimulus; 3=Subject responds to stimulus, considers it painful and requests discontinuation.&#xD;
Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.</description>
        <time_frame>Immediately after treatment .</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>NUPRO Sensodyne Prophy Paste w/ Novamin&#xD;
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride.&#xD;
Leave in contact for 60 seconds, rinse with water and expectorate.</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride&#xD;
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.&#xD;
Leave in contact for 60 seconds, rinse with water and expectorate.</description>
          </group>
          <group group_id="O3">
            <title>Group C</title>
            <description>NUPRO Classic Prophy Paste&#xD;
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride..&#xD;
Leave in contact for 60 seconds, rinse with water and expectorate.</description>
          </group>
        </group_list>
        <measure>
          <title>Immediate Sensitivity Relief (Schiff Air Blast Sensitivity)</title>
          <description>Assessment of sensitivity score via air blast measurements immediately after treatment.&#xD;
Air blast hypersensitivity is measured using the Schiff Cold Air Sensitivity scale (0-3). The scale is scored as follows:&#xD;
0=Subject does not respond to stimulus; 1= Subject responds to stimulus but does not request discontinuation of stimulus; 2=Subject responds to stimulus and requests discontinuation or moves from air stimulus; 3=Subject responds to stimulus, considers it painful and requests discontinuation.&#xD;
Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.</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="45"/>
                <count group_id="O2" value="48"/>
                <count group_id="O3" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.88" spread="0.64"/>
                    <measurement group_id="O2" value="0.97" spread="0.52"/>
                    <measurement group_id="O3" value="1.72" spread="0.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Long-term Sensitivity Relief (Schiff Air Blast Sensitivity)</title>
        <description>Assessment of sensitivity score Schiff air blast measurements long term after treatment.&#xD;
Air blast hypersensitivity is measured using the Schiff Cold Air Sensitivity scale (0-3). The scale is scored as follows:&#xD;
0=Subject does not respond to stimulus; 1= Subject responds to stimulus but does not request discontinuation of stimulus; 2=Subject responds to stimulus and requests discontinuation or moves from air stimulus; 3=Subject responds to stimulus, considers it painful and requests discontinuation.&#xD;
Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.</description>
        <time_frame>28 days (+/- 2 days) post treatment.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>NUPRO Sensodyne Prophy Paste w/ Novamin&#xD;
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride.&#xD;
Leave in contact for 60 seconds, rinse with water and expectorate.</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride&#xD;
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.&#xD;
Leave in contact for 60 seconds, rinse with water and expectorate.</description>
          </group>
          <group group_id="O3">
            <title>Group C</title>
            <description>NUPRO Classic Prophy Paste&#xD;
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride..&#xD;
Leave in contact for 60 seconds, rinse with water and expectorate.</description>
          </group>
        </group_list>
        <measure>
          <title>Long-term Sensitivity Relief (Schiff Air Blast Sensitivity)</title>
          <description>Assessment of sensitivity score Schiff air blast measurements long term after treatment.&#xD;
Air blast hypersensitivity is measured using the Schiff Cold Air Sensitivity scale (0-3). The scale is scored as follows:&#xD;
0=Subject does not respond to stimulus; 1= Subject responds to stimulus but does not request discontinuation of stimulus; 2=Subject responds to stimulus and requests discontinuation or moves from air stimulus; 3=Subject responds to stimulus, considers it painful and requests discontinuation.&#xD;
Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.</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="45"/>
                <count group_id="O2" value="48"/>
                <count group_id="O3" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.87" spread="0.63"/>
                    <measurement group_id="O2" value="1.11" spread="0.61"/>
                    <measurement group_id="O3" value="1.67" spread="0.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Post- Scaling Sensitivity Relief (Self-Assessment)</title>
        <description>All subjects completed a questionnaire titled &quot;How sensitive are your teeth?&quot; to assess their whole-mouth tooth sensitivity immediately following the scaling procedure.&#xD;
The questionnaire contained a 4-item verbal descriptor scale as follows:&#xD;
Score 0= no discomfort or awareness of sensitivity; 1=mild discomfort/pain from sensitive teeth; 2=moderate discomfort/pain from sensitive teeth; 3=severe pain from sensitive teeth.&#xD;
The higher the score, the higher the hypersensitivity.&#xD;
Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.</description>
        <time_frame>Post-scaling procedure,immediate</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>NUPRO Sensodyne Prophy Paste w/ Novamin&#xD;
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride.&#xD;
Leave in contact for 60 seconds, rinse with water and expectorate.</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride&#xD;
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.&#xD;
Leave in contact for 60 seconds, rinse with water and expectorate.</description>
          </group>
          <group group_id="O3">
            <title>Group C</title>
            <description>NUPRO Classic Prophy Paste&#xD;
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride..&#xD;
Leave in contact for 60 seconds, rinse with water and expectorate.</description>
          </group>
        </group_list>
        <measure>
          <title>Post- Scaling Sensitivity Relief (Self-Assessment)</title>
          <description>All subjects completed a questionnaire titled &quot;How sensitive are your teeth?&quot; to assess their whole-mouth tooth sensitivity immediately following the scaling procedure.&#xD;
The questionnaire contained a 4-item verbal descriptor scale as follows:&#xD;
Score 0= no discomfort or awareness of sensitivity; 1=mild discomfort/pain from sensitive teeth; 2=moderate discomfort/pain from sensitive teeth; 3=severe pain from sensitive teeth.&#xD;
The higher the score, the higher the hypersensitivity.&#xD;
Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.</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="45"/>
                <count group_id="O2" value="48"/>
                <count group_id="O3" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.31" spread="0.79"/>
                    <measurement group_id="O2" value="0.98" spread="0.67"/>
                    <measurement group_id="O3" value="1.28" spread="0.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Post-prophylaxis Sensitivity Relief (Self-Assessment)</title>
        <description>All subjects completed a questionnaire titled &quot;How sensitive are your teeth?&quot; to assess their whole-mouth tooth sensitivity immediately following the timed, 1-minute prophylaxis paste application.&#xD;
The questionnaire contained a 4-item verbal descriptor scale as follows:&#xD;
Score 0= no discomfort or awareness of sensitivity; 1=mild discomfort/pain from sensitive teeth;2=moderate discomfort/pain from sensitive teeth; 3=severe pain from sensitive teeth.&#xD;
The higher the score, the higher the hypersensitivity.&#xD;
Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.</description>
        <time_frame>Immediately following post-prophylaxis treatment.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>NUPRO Sensodyne Prophy Paste w/ Novamin&#xD;
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride.&#xD;
Leave in contact for 60 seconds, rinse with water and expectorate.</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride&#xD;
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.&#xD;
Leave in contact for 60 seconds, rinse with water and expectorate.</description>
          </group>
          <group group_id="O3">
            <title>Group C</title>
            <description>NUPRO Classic Prophy Paste&#xD;
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride..&#xD;
Leave in contact for 60 seconds, rinse with water and expectorate.</description>
          </group>
        </group_list>
        <measure>
          <title>Post-prophylaxis Sensitivity Relief (Self-Assessment)</title>
          <description>All subjects completed a questionnaire titled &quot;How sensitive are your teeth?&quot; to assess their whole-mouth tooth sensitivity immediately following the timed, 1-minute prophylaxis paste application.&#xD;
The questionnaire contained a 4-item verbal descriptor scale as follows:&#xD;
Score 0= no discomfort or awareness of sensitivity; 1=mild discomfort/pain from sensitive teeth;2=moderate discomfort/pain from sensitive teeth; 3=severe pain from sensitive teeth.&#xD;
The higher the score, the higher the hypersensitivity.&#xD;
Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.</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="45"/>
                <count group_id="O2" value="48"/>
                <count group_id="O3" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.00" spread="0.90"/>
                    <measurement group_id="O2" value="0.90" spread="0.81"/>
                    <measurement group_id="O3" value="1.09" spread="0.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Long-term Sensitivity Relief (Self-Assessment)</title>
        <description>All subjects completed a questionnaire titled &quot;How sensitive are your teeth?&quot; to assess their whole-mouth tooth sensitivity 28 days following prophylaxis treatment.&#xD;
The questionnaire contained a 4-item verbal descriptor scale as follows:&#xD;
Score 0= no discomfort or awareness of sensitivity;1=mild discomfort/pain from sensitive teeth; 2=moderate discomfort/pain from sensitive teeth; 3=severe pain from sensitive teeth.&#xD;
The higher the score, the higher the hypersensitivity.&#xD;
Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.</description>
        <time_frame>28 days post-prophylaxis treatment.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>NUPRO Sensodyne Prophy Paste w/ Novamin&#xD;
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride.&#xD;
Leave in contact for 60 seconds, rinse with water and expectorate.</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride&#xD;
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.&#xD;
Leave in contact for 60 seconds, rinse with water and expectorate.</description>
          </group>
          <group group_id="O3">
            <title>Group C</title>
            <description>NUPRO Classic Prophy Paste&#xD;
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride..&#xD;
Leave in contact for 60 seconds, rinse with water and expectorate.</description>
          </group>
        </group_list>
        <measure>
          <title>Long-term Sensitivity Relief (Self-Assessment)</title>
          <description>All subjects completed a questionnaire titled &quot;How sensitive are your teeth?&quot; to assess their whole-mouth tooth sensitivity 28 days following prophylaxis treatment.&#xD;
The questionnaire contained a 4-item verbal descriptor scale as follows:&#xD;
Score 0= no discomfort or awareness of sensitivity;1=mild discomfort/pain from sensitive teeth; 2=moderate discomfort/pain from sensitive teeth; 3=severe pain from sensitive teeth.&#xD;
The higher the score, the higher the hypersensitivity.&#xD;
Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.</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="45"/>
                <count group_id="O2" value="48"/>
                <count group_id="O3" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.60" spread="0.62"/>
                    <measurement group_id="O2" value="0.50" spread="0.71"/>
                    <measurement group_id="O3" value="0.72" spread="0.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Patients were monitored for adverse events during intraoral examinations performed after paste application and 28 days following paste application.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Group A</title>
          <description>NUPRO Sensodyne Prophy Paste w/ Novamin&#xD;
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride.&#xD;
Leave in contact for 60 seconds, rinse with water and expectorate.</description>
        </group>
        <group group_id="E2">
          <title>Group B</title>
          <description>NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride&#xD;
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.&#xD;
Leave in contact for 60 seconds, rinse with water and expectorate.</description>
        </group>
        <group group_id="E3">
          <title>Group C</title>
          <description>NUPRO Classic Prophy Paste&#xD;
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride..&#xD;
Leave in contact for 60 seconds, rinse with water and expectorate.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
              </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="45"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
              </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>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Jeffery L. Milleman, DDS, MPA</name_or_title>
      <organization>Salus Research, Inc.</organization>
      <phone>260-755-1099</phone>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01669785
org study id: CTP-002
nct id: NCT01669785
lead sponsor: 
has dmc: No
The study is intended to verify through clinical measurement that the NUPRO Sensodyne
      Prophylaxis Paste with Novamin provides immediate sensitivity relief as well as extended
      relief up to 28 days.
It is hypothesized that the prophy paste with Novamin will give patients immediate
      sensitivity relief, as well as sensitivity relief up to 4 weeks (28 days) after measurement.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Baseline Pre-Prophy Assessment (Tactile Sensitivity)
time frame: Pre-treatment measurement
description: Pre-prophy procedure baseline assessment is measured with an electronic force sensing probe (Yeaple probe). Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. 10,20,30,40, up to 50 grams of force are applied to the hypersensitive tooth until pain is elicited. The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitiv
Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.
measure: Immediate Sensitivity Relief (Tactile Sensitivity)
time frame: Immediately after treatment .
description: Assessment of sensitivity score via tactile and air blast measurements immediately after treatment. Tactile hypersensitivity is measured with an electronic force sensing probel (Yeaple probe). Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. 10, 20, 30, 40 up to 50 grams of force are applied to the hypersensitive tooth until pain is elicited. The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitivity.
Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.
measure: Long-term Sensitivity Relief (Tactile Sensitivity)
time frame: 28 days (+/- 2 days) post treatment.
description: Assessment of sensitivity score via tactile measurements long term after treatment.
Tactile hypersensitivity is measured with an electronic force sensing probel (Yeaple probe). Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. 10 to 50 grams of force are applied to the hypersensitive tooth until pain is elicited. The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitivity.
Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.
measure: Baseline Pre-Prophy Assessment (Air Blast Sensitivity)
time frame: Pre-treatment measurement
description: Pre-prophy procedure baseline assessment using Schiff Cold Air Sensitivity scale (0-3).
Air blast hypersensitivity is measured using the Schiff Cold Air Sensitivty scale (0-3). The scale is scored as follows:
0=Subject does not respond to stimulus; 1= Subject responds to stimulus but does not request discontinuation of stimulus; 2=Subject responds to stimulus and requests discontinuation or moves from air stimulus; 3=Subject responds to stimulus, considers it painful and requests discontinuation.
The higher the score, the higher the hypersensitivity.
Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.
measure: Immediate Sensitivity Relief (Schiff Air Blast Sensitivity)
time frame: Immediately after treatment .
description: Assessment of sensitivity score via air blast measurements immediately after treatment.
Air blast hypersensitivity is measured using the Schiff Cold Air Sensitivity scale (0-3). The scale is scored as follows:
0=Subject does not respond to stimulus; 1= Subject responds to stimulus but does not request discontinuation of stimulus; 2=Subject responds to stimulus and requests discontinuation or moves from air stimulus; 3=Subject responds to stimulus, considers it painful and requests discontinuation.
Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.
measure: Long-term Sensitivity Relief (Schiff Air Blast Sensitivity)
time frame: 28 days (+/- 2 days) post treatment.
description: Assessment of sensitivity score Schiff air blast measurements long term after treatment.
Air blast hypersensitivity is measured using the Schiff Cold Air Sensitivity scale (0-3). The scale is scored as follows:
0=Subject does not respond to stimulus; 1= Subject responds to stimulus but does not request discontinuation of stimulus; 2=Subject responds to stimulus and requests discontinuation or moves from air stimulus; 3=Subject responds to stimulus, considers it painful and requests discontinuation.
Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.
measure: Sensitivity Relief (Self-Assessment)
time frame: Pre-Treatment
description: All subjects completed a questionnaire titled "How sensitive are your teeth?" to assess their whole-mouth tooth sensitivity prior to the baseline assessments.
The questionnaire contained a 4-item verbal descriptor scale as follows:
Score 0= no discomfort or awareness of sensitivity; 1=mild discomfort/pain from sensitive teeth; 2=moderate discomfort/pain from sensitive teeth; 3=severe pain from sensitive teeth.
The higher the score, the higher the hypersensitivity.
Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.
measure: Post- Scaling Sensitivity Relief (Self-Assessment)
time frame: Post-scaling procedure,immediate
description: All subjects completed a questionnaire titled "How sensitive are your teeth?" to assess their whole-mouth tooth sensitivity immediately following the scaling procedure.
The questionnaire contained a 4-item verbal descriptor scale as follows:
Score 0= no discomfort or awareness of sensitivity; 1=mild discomfort/pain from sensitive teeth; 2=moderate discomfort/pain from sensitive teeth; 3=severe pain from sensitive teeth.
The higher the score, the higher the hypersensitivity.
Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.
measure: Post-prophylaxis Sensitivity Relief (Self-Assessment)
time frame: Immediately following post-prophylaxis treatment.
description: All subjects completed a questionnaire titled "How sensitive are your teeth?" to assess their whole-mouth tooth sensitivity immediately following the timed, 1-minute prophylaxis paste application.
The questionnaire contained a 4-item verbal descriptor scale as follows:
Score 0= no discomfort or awareness of sensitivity; 1=mild discomfort/pain from sensitive teeth;2=moderate discomfort/pain from sensitive teeth; 3=severe pain from sensitive teeth.
The higher the score, the higher the hypersensitivity.
Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.
measure: Long-term Sensitivity Relief (Self-Assessment)
time frame: 28 days post-prophylaxis treatment.
description: All subjects completed a questionnaire titled "How sensitive are your teeth?" to assess their whole-mouth tooth sensitivity 28 days following prophylaxis treatment.
The questionnaire contained a 4-item verbal descriptor scale as follows:
Score 0= no discomfort or awareness of sensitivity;1=mild discomfort/pain from sensitive teeth; 2=moderate discomfort/pain from sensitive teeth; 3=severe pain from sensitive teeth.
The higher the score, the higher the hypersensitivity.
Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.
arm group label: Group C
arm group type: Active Comparator
description: NUPRO Classic Prophy Paste
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride..
Leave in contact for 60 seconds, rinse with water and expectorate.
arm group label: Group A
arm group type: Experimental
description: NUPRO Sensodyne Prophy Paste w/ Novamin
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride.
Leave in contact for 60 seconds, rinse with water and expectorate
arm group label: Group B
arm group type: Experimental
description: NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.
Leave in contact for 60 seconds, rinse with water and expectorate.
intervention type: Device
intervention name: Group C
description: Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
arm group label: Group C
other name: NUPRO Classic Prophy Paste
intervention type: Device
intervention name: Group A
description: Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
arm group label: Group B
other name: NUPRO Sensodyne Prophy Paste with NovaMin with Fluoride.
intervention type: Device
intervention name: Group B
description: Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
arm group label: Group A
other name: NUPRO Sensodyne Prophy Paste with NovaMin without Fluoride.
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jeffrey L Milleman, DDS, MPA
role: Principal Investigator
affiliation: Salus Research
facility: 
country: United States
responsible party type: Sponsor
mesh term: Dentin Sensitivity
mesh term: Hypersensitivity
mesh term: Listerine
mesh term: Fluorides
mesh term: Sodium Fluoride
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 