<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/NCT03244618</url>
  </required_header>
  <id_info>
    <org_study_id>ORL-SEN-2530</org_study_id>
    <nct_id>NCT03244618</nct_id>
  </id_info>
  <brief_title>A Study to Measure the Efficacy of a Toothpaste on Dentinal Hypersensitivity</brief_title>
  <official_title>A Medical Device Study to Measure the Efficacy of a Toothpaste Containing Calcium-silicate/Phosphate on Dentinal Hypersensitivity Compared to a Control Toothpaste Containing Fluoride.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Unilever R&amp;D</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Bristol</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Unilever R&amp;D</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Double blind parallel study to measure the efficacy of a toothpaste containing&#xD;
      calcium-silicate/phosphate on dentinal hypersensitivity compared to a control toothpaste&#xD;
      containing fluoride&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a double blind parallel design, with respect to the clinical assessor and subject,&#xD;
      study. A minimum of 280 (140 per group), male and female subjects will be recruited to ensure&#xD;
      that a minimum of 200 subjects (100 per group) complete the study. Subjects will attend the&#xD;
      test site on six (6) occasions.&#xD;
&#xD;
      Subjects will be screened according to the inclusion and exclusion criteria. Suitable&#xD;
      subjects will be given a standard fluoride toothpaste and a toothbrush to use for the&#xD;
      following four to six weeks (Run-in Phase).&#xD;
&#xD;
      On completion of the run in phase, the subjects will have a baseline sensitivity and soft&#xD;
      tissue assessments conducted and randomised to product (visit 3).&#xD;
&#xD;
      Subjects will be randomly assigned to the test groups.&#xD;
&#xD;
      Subjects will be given sufficient supplies of their allocated toothpaste and a toothbrush to&#xD;
      use for the following 2 weeks. Instructions for use (IFUs) will be given to the subjects&#xD;
      along with a toothbrushing diary and an appointment to return to the test site 2 weeks (+/-1&#xD;
      day) later.&#xD;
&#xD;
      At the Day 14 visit, subjects will have the dentinal hypersensitivity and soft tissue&#xD;
      assessments repeated.&#xD;
&#xD;
      Subjects will be given sufficient supplies of their allocated toothpaste and a toothbrush to&#xD;
      use for the following 2 weeks. A fresh toothbrushing diary will be given to the subject along&#xD;
      with an appointment to return to the test site 2 weeks later (Week 4 assessment). Subjects&#xD;
      will be instructed to brush their teeth as per the IFU for the following 2 weeks.&#xD;
&#xD;
      At the Day 28 visit subjects will have the dentinal hypersensitivity and soft tissue&#xD;
      assessments repeated. Prior to leaving the study site, the subjects will be asked to brush&#xD;
      their teeth as per the IFU. Subjects will be requested to brush their teeth at a specific&#xD;
      time and return to the study site the following day.&#xD;
&#xD;
      At the Day 29 visit, subjects will have the dentinal hypersensitivity and soft tissue&#xD;
      assessments repeated. On completion of the assessments, subjects will receive their&#xD;
      remuneration for the participating in the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 19, 2017</start_date>
  <completion_date type="Actual">June 13, 2018</completion_date>
  <primary_completion_date type="Actual">June 13, 2018</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, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Thermo-evaporative (Schiff Air Blast) Stimuli</measure>
    <time_frame>4-weeks of product use (Day 28)</time_frame>
    <description>Air blast sensitivity assessed by directing a one-second blast of air onto the exposed buccal root surface of sensitive tooth. Sensitivity recorded: 0 = Tooth/Subject does not respond; 1 Tooth/subject responds but does not request discontinuation; 2 Tooth/subject responds and requests discontinuation or moves;3 Tooth/subject responds, considers stimulus to be painful, and requests discontinuation. Each subject will be characterised at each visit by the average of the relevant scores for the two indicator teeth. HIgher score is worse outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tactile (Yeaple Probe) Stimuli</measure>
    <time_frame>4-weeks of product use (Day 28)</time_frame>
    <description>The Yeaple score is recorded in terms of quantified reproducible force (range 10-60 grams with higher values indicating a better outcome). The Yeaple probe tip with a force of 10 grams is passed over the exposed dentin on the buccal surface of the selected teeth, apical to the cementenamel junction and the applied force in increased each time by 10 grams until the participant indicates that he/she is experiencing discomfort, or until 20 grams (baseline) or 60 grams (post product use) of force is reached. A higher value indicates lower levels of dentinal hypersensitivity. Each subject will be characterised at each visit by the average of the relevant scores for the two indicator teeth.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Analogue Scale</measure>
    <time_frame>4-weeks of product use (Day 28)</time_frame>
    <description>Visual Analogue Scale values were recorded to give the outcome variable per subject at the same time asSchiff assessment. The VAS values were assigned a numerical value in the conventional order from 0 (no pain) to 100 (extremely pain).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Thermo-evaporative (Schiff Air Blast) Stimuli</measure>
    <time_frame>Day 29, 12 hours after product use has ceased</time_frame>
    <description>Air blast sensitivity assessed by directing a one-second blast of air onto the exposed buccal root surface of sensitive tooth. Sensitivity will be recorded: 0 = Tooth/Subject does not respond; 1 Tooth/subject responds but does not request discontinuation; 2 Tooth/subject responds and requests discontinuation or moves;3 Tooth/subject responds, considers stimulus to be painful, and requests discontinuation. Each subject will be characterised at each visit by the average of the relevant scores for the two indicator teeth.</description>
  </other_outcome>
  <other_outcome>
    <measure>Tactile (Yeaple Probe) Stimuli</measure>
    <time_frame>Day 29, 12 hours after product use has ceased</time_frame>
    <description>The Yeaple score is recorded in terms of quantified reproducible force (range 10-60 grams with higher values indicating a better outcome). The Yeaple probe tip with a force of 10 grams is passed over the exposed dentin on the buccal surface of the selected teeth, apical to the cementenamel junction and the applied force in increased each time by 10 grams until the participant indicates that he/she is experiencing discomfort, or until 20 grams (baseline) or 60 grams (post product use) of force is reached. A higher value indicates lower levels of dentinal hypersensitivity. Each subject will be characterised at each visit by the average of the relevant scores for the two indicator teeth.</description>
  </other_outcome>
  <other_outcome>
    <measure>Visual Analogue Scale</measure>
    <time_frame>Day 29, 12 hours after product use has ceased</time_frame>
    <description>Visual Analogue Scale values of the same teeth will be also be recorded to give the outcome variable per subject at the same time of Schiff assessment. The VAS values will be assigned a numerical value in the conventional order from 0 (no pain) to 100 (extremely pain).</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">272</enrollment>
  <condition>Dentin Sensitivity</condition>
  <arm_group>
    <arm_group_label>CSSP Toothpaste</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Toothpaste containing Calcium Silicate and Sodium Phosphate</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fluoride Toothpaste</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Toothpaste containing Sodium monofluorphosphate</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CSSP Toothpaste</intervention_name>
    <description>Toothpaste containing calcium silicate, sodium phosphate and sodium monofluorophosphate</description>
    <arm_group_label>CSSP Toothpaste</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Fluoride Toothpaste</intervention_name>
    <description>Toothpaste containing sodium monofluorphosphate</description>
    <arm_group_label>Fluoride Toothpaste</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female subjects aged 18 years and older.&#xD;
&#xD;
          -  Willing and physically able to carry out all study procedures.&#xD;
&#xD;
          -  Willing and able to give written informed consent and complete a medical history form.&#xD;
&#xD;
          -  Have at least one hypersensitive tooth in two quadrants, which are anterior to the&#xD;
             molars and demonstrate cervical dentine, which have an air-blast hypersensitivity&#xD;
             score of 2 or 3 on the Schiff sensitivity scale at Screening and Baseline and a&#xD;
             tactile hypersensitivity score of 10-20 grams of force at baseline.&#xD;
&#xD;
          -  Willing to comply with the oral hygiene and food and drink restrictions.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who have used anti sensitivity products in the 4 weeks prior to screening&#xD;
&#xD;
          -  Subjects with an active oral ulcer (Aphthous ulcer), or have similar experience within&#xD;
             past 1 month.&#xD;
&#xD;
          -  Subjects who use a powered toothbrush at least 4 times a week to brush their teeth&#xD;
&#xD;
          -  Subjects whose indicator teeth have abnormal oral pathology, for example:&#xD;
&#xD;
               -  Extensive restorations.&#xD;
&#xD;
               -  Observable caries.&#xD;
&#xD;
               -  Observable cracked enamel.&#xD;
&#xD;
               -  Leaking fillings or other restorations.&#xD;
&#xD;
               -  Cracked Tooth Syndrome&#xD;
&#xD;
               -  Suspected pulp pathology/abscess/pulpitis.&#xD;
&#xD;
               -  Atypical facial pain&#xD;
&#xD;
               -  Any tooth surface adjacent to those surfaces under investigation, which in the&#xD;
                  opinion of the investigator have any other condition(s) that provide confusing&#xD;
                  symptoms to those of cervical dentine hypersensitivity.&#xD;
&#xD;
          -  Currently undergoing dental treatment, including orthodontic treatment.&#xD;
&#xD;
          -  Subjects who have had vital bleaching within 4 weeks of the screening visit&#xD;
&#xD;
          -  Known allergies to any toothpaste ingredients, including the flavour components.&#xD;
&#xD;
          -  Obvious physical disability reducing tooth brushing ability.&#xD;
&#xD;
          -  Receiving concomitant medication/therapy that might affect dentine hypersensitivity,&#xD;
             e.g. regular use of analgesics, anti-histamines, non-steroidal anti-inflammatory drug&#xD;
             and selective serotonin reuptake inhibitor medication&#xD;
&#xD;
          -  Severe gingivitis, periodontitis and/or marked tooth mobility.&#xD;
&#xD;
          -  Gingival surgery in the previous six months.&#xD;
&#xD;
          -  In the opinion of the investigator unable to comply fully with the trial requirements.&#xD;
&#xD;
          -  Participation in other dental clinical trials in the previous 28 days&#xD;
&#xD;
          -  Subjects who have participated in an dentinal hypersensitivity study within the&#xD;
             previous 1 month.&#xD;
&#xD;
          -  Diabetic (both Type 1 and Type 2)&#xD;
&#xD;
          -  Medical condition(s) and/or regular use of any medication, which either could affect&#xD;
             the scientific validity of the study or if the subject was to participate in the study&#xD;
             could, affect their wellbeing.&#xD;
&#xD;
          -  Smokers or e-cigarette use or those who have smoked/vaped in the previous 12 months&#xD;
&#xD;
          -  Brushing &lt; 10 times a week during the Run-In period (self-reported)&#xD;
&#xD;
          -  Using &lt;17g or &gt; 53g of toothpaste in a two week period during the test phase&#xD;
&#xD;
          -  The subject is an employee of Unilever or the site conducting the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nicola X West, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Bristol</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>School of Oral and Dental Science</name>
      <address>
        <city>Bristol</city>
        <zip>BS1 2LY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>July 18, 2017</study_first_submitted>
  <study_first_submitted_qc>August 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <results_first_submitted>July 20, 2020</results_first_submitted>
  <results_first_submitted_qc>September 9, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">October 5, 2020</results_first_posted>
  <last_update_submitted>September 9, 2020</last_update_submitted>
  <last_update_submitted_qc>September 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 5, 2020</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>Fluorides</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 4, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/18/NCT03244618/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were recruited at a single center in Bristol, United Kingdom.</recruitment_details>
      <pre_assignment_details>Participants brushed for 4-6 weeks with fluoride toothpaste during run-in period between enrollment and randomization. 272 participants were enrolled out of which 263 were randomized. Reasons for participant not being randomized:&#xD;
Did not meet Baseline inclusion criteria (n=1)&#xD;
Withdrawal by subject (n=6)&#xD;
Lost to follow-up (n=2)</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>CSSP Toothpaste</title>
          <description>Toothpaste containing calcium silicate, sodium phosphate and sodium monofluorophosphate. Participants were asked to brush for two minutes with the toothpaste twice per day, morning and evening, using their normal routine. After the evening brush, partipants were instructed to massage a pea sized amount of the toothpaste into the sensitive surfaces of the two selected sensitive teeth for 30 seconds.</description>
        </group>
        <group group_id="P2">
          <title>Fluoride Toothpaste</title>
          <description>Toothpaste containing sodium monofluorphosphate. Participants were asked to brush for two minutes with the toothpaste twice per day, morning and evening, using their normal routine. After the evening brush, partipants were instructed to massage a pea sized amount of the toothpaste into the sensitive surfaces of the two selected sensitive teeth for 30 seconds.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="132"/>
                <participants group_id="P2" count="131"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Week 2</title>
              <participants_list>
                <participants group_id="P1" count="128"/>
                <participants group_id="P2" count="125"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="125"/>
                <participants group_id="P2" count="122"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>CSSP Toothpaste</title>
          <description>Toothpaste containing calcium silicate, sodium phosphate and sodium monofluorophosphate. Participants were asked to brush for two minutes with the toothpaste twice per day, morning and evening, using their normal routine. After the evening brush, partipants were instructed to massage a pea sized amount of the toothpaste into the sensitive surfaces of the two selected sensitive teeth for 30 seconds.</description>
        </group>
        <group group_id="B2">
          <title>Fluoride Toothpaste</title>
          <description>Toothpaste containing sodium monofluorphosphate. Participants were asked to brush for two minutes with the toothpaste twice per day, morning and evening, using their normal routine. After the evening brush, partipants were instructed to massage a pea sized amount of the toothpaste into the sensitive surfaces of the two selected sensitive teeth for 30 seconds.</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="132"/>
            <count group_id="B2" value="131"/>
            <count group_id="B3" value="263"/>
          </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="34.4" spread="12.7"/>
                    <measurement group_id="B2" value="37.4" spread="13.5"/>
                    <measurement group_id="B3" value="35.9" spread="13.2"/>
                  </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="72"/>
                    <measurement group_id="B2" value="71"/>
                    <measurement group_id="B3" value="143"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                    <measurement group_id="B2" value="60"/>
                    <measurement group_id="B3" value="120"/>
                  </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>Caucasian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="106"/>
                    <measurement group_id="B2" value="104"/>
                    <measurement group_id="B3" value="210"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                  </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 Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="132"/>
                    <measurement group_id="B2" value="131"/>
                    <measurement group_id="B3" value="263"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Thermo-evaporative (Schiff air blast) stimuli</title>
          <description>Air blast sensitivity assessed by directing a one-second blast of air onto the exposed buccal root surface of sensitive tooth. Sensitivity recorded: 0 = Tooth/Subject does not respond; 1 Tooth/subject responds but does not request discontinuation; 2 Tooth/subject responds and requests discontinuation or moves;3 Tooth/subject responds, considers stimulus to be painful, and requests discontinuation. Each subject will be characterised at each visit by the average of the relevant scores for the two indicator teeth. HIgher score is worse outcome.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.193" spread="0.336"/>
                    <measurement group_id="B2" value="2.256" spread="0.336"/>
                    <measurement group_id="B3" value="2.224" spread="0.337"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Thermo-evaporative (Schiff Air Blast) Stimuli</title>
        <description>Air blast sensitivity assessed by directing a one-second blast of air onto the exposed buccal root surface of sensitive tooth. Sensitivity recorded: 0 = Tooth/Subject does not respond; 1 Tooth/subject responds but does not request discontinuation; 2 Tooth/subject responds and requests discontinuation or moves;3 Tooth/subject responds, considers stimulus to be painful, and requests discontinuation. Each subject will be characterised at each visit by the average of the relevant scores for the two indicator teeth. HIgher score is worse outcome.</description>
        <time_frame>4-weeks of product use (Day 28)</time_frame>
        <population>Analysis was based on all available data at week 4 from subjects who were randomised</population>
        <group_list>
          <group group_id="O1">
            <title>CSSP Toothpaste</title>
            <description>Toothpaste containing calcium silicate, sodium phosphate and sodium monofluorophosphate. Participants were asked to brush for two minutes with the toothpaste twice per day, morning and evening, using their normal routine. After the evening brush, partipants were instructed to massage a pea sized amount of the toothpaste into the sensitive surfaces of the two selected sensitive teeth for 30 seconds.</description>
          </group>
          <group group_id="O2">
            <title>Fluoride Toothpaste</title>
            <description>Toothpaste containing sodium monofluorphosphate. Participants were asked to brush for two minutes with the toothpaste twice per day, morning and evening, using their normal routine. After the evening brush, partipants were instructed to massage a pea sized amount of the toothpaste into the sensitive surfaces of the two selected sensitive teeth for 30 seconds.</description>
          </group>
        </group_list>
        <measure>
          <title>Thermo-evaporative (Schiff Air Blast) Stimuli</title>
          <description>Air blast sensitivity assessed by directing a one-second blast of air onto the exposed buccal root surface of sensitive tooth. Sensitivity recorded: 0 = Tooth/Subject does not respond; 1 Tooth/subject responds but does not request discontinuation; 2 Tooth/subject responds and requests discontinuation or moves;3 Tooth/subject responds, considers stimulus to be painful, and requests discontinuation. Each subject will be characterised at each visit by the average of the relevant scores for the two indicator teeth. HIgher score is worse outcome.</description>
          <population>Analysis was based on all available data at week 4 from subjects who were randomised</population>
          <units>score 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="125"/>
                <count group_id="O2" value="122"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.188" spread="0.334"/>
                    <measurement group_id="O2" value="2.246" spread="0.329"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.268" spread="0.723"/>
                    <measurement group_id="O2" value="1.811" spread="0.624"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <method_desc>ANOVA model had treatment and gender as factors.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.544</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.712</ci_lower_limit>
            <ci_upper_limit>-0.377</ci_upper_limit>
            <estimate_desc>Difference is first named toothpaste minus second named toothpaste such that a negative difference favours first named toothpaste.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Tactile (Yeaple Probe) Stimuli</title>
        <description>The Yeaple score is recorded in terms of quantified reproducible force (range 10-60 grams with higher values indicating a better outcome). The Yeaple probe tip with a force of 10 grams is passed over the exposed dentin on the buccal surface of the selected teeth, apical to the cementenamel junction and the applied force in increased each time by 10 grams until the participant indicates that he/she is experiencing discomfort, or until 20 grams (baseline) or 60 grams (post product use) of force is reached. A higher value indicates lower levels of dentinal hypersensitivity. Each subject will be characterised at each visit by the average of the relevant scores for the two indicator teeth.</description>
        <time_frame>4-weeks of product use (Day 28)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>CSSP Toothpaste</title>
            <description>Toothpaste containing calcium silicate, sodium phosphate and sodium monofluorophosphate. Participants were asked to brush for two minutes with the toothpaste twice per day, morning and evening, using their normal routine. After the evening brush, partipants were instructed to massage a pea sized amount of the toothpaste into the sensitive surfaces of the two selected sensitive teeth for 30 seconds.</description>
          </group>
          <group group_id="O2">
            <title>Fluoride Toothpaste</title>
            <description>Toothpaste containing sodium monofluorphosphate. Participants were asked to brush for two minutes with the toothpaste twice per day, morning and evening, using their normal routine. After the evening brush, partipants were instructed to massage a pea sized amount of the toothpaste into the sensitive surfaces of the two selected sensitive teeth for 30 seconds.</description>
          </group>
        </group_list>
        <measure>
          <title>Tactile (Yeaple Probe) Stimuli</title>
          <description>The Yeaple score is recorded in terms of quantified reproducible force (range 10-60 grams with higher values indicating a better outcome). The Yeaple probe tip with a force of 10 grams is passed over the exposed dentin on the buccal surface of the selected teeth, apical to the cementenamel junction and the applied force in increased each time by 10 grams until the participant indicates that he/she is experiencing discomfort, or until 20 grams (baseline) or 60 grams (post product use) of force is reached. A higher value indicates lower levels of dentinal hypersensitivity. Each subject will be characterised at each visit by the average of the relevant scores for the two indicator teeth.</description>
          <units>score 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="125"/>
                <count group_id="O2" value="122"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.5" spread="3.46"/>
                    <measurement group_id="O2" value="16.6" spread="3.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.2" spread="14.4"/>
                    <measurement group_id="O2" value="27.5" spread="11.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <method_desc>ANOVA model had treatment and gender as factors.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>10.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>7.5</ci_lower_limit>
            <ci_upper_limit>14.0</ci_upper_limit>
            <estimate_desc>Difference is first names toothpaste minus second named toothpaste such that a positive difference favours the first named toothpaste.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Visual Analogue Scale</title>
        <description>Visual Analogue Scale values were recorded to give the outcome variable per subject at the same time asSchiff assessment. The VAS values were assigned a numerical value in the conventional order from 0 (no pain) to 100 (extremely pain).</description>
        <time_frame>4-weeks of product use (Day 28)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>CSSP Toothpaste</title>
            <description>Toothpaste containing calcium silicate, sodium phosphate and sodium monofluorophosphate. Participants were asked to brush for two minutes with the toothpaste twice per day, morning and evening, using their normal routine. After the evening brush, partipants were instructed to massage a pea sized amount of the toothpaste into the sensitive surfaces of the two selected sensitive teeth for 30 seconds.</description>
          </group>
          <group group_id="O2">
            <title>Fluoride Toothpaste</title>
            <description>Toothpaste containing sodium monofluorphosphate. Participants were asked to brush for two minutes with the toothpaste twice per day, morning and evening, using their normal routine. After the evening brush, partipants were instructed to massage a pea sized amount of the toothpaste into the sensitive surfaces of the two selected sensitive teeth for 30 seconds.</description>
          </group>
        </group_list>
        <measure>
          <title>Visual Analogue Scale</title>
          <description>Visual Analogue Scale values were recorded to give the outcome variable per subject at the same time asSchiff assessment. The VAS values were assigned a numerical value in the conventional order from 0 (no pain) to 100 (extremely pain).</description>
          <units>score 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="125"/>
                <count group_id="O2" value="122"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.1" spread="20.5"/>
                    <measurement group_id="O2" value="49.9" spread="19.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.1" spread="22.8"/>
                    <measurement group_id="O2" value="42.0" spread="22.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <method_desc>ANOVA model had treatment and gender as factors.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-11.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-16.4</ci_lower_limit>
            <ci_upper_limit>-5.5</ci_upper_limit>
            <estimate_desc>Difference is first named toothpaste minus second named toothpaste such that a negative difference favours the first named toothpaste.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Thermo-evaporative (Schiff Air Blast) Stimuli</title>
        <description>Air blast sensitivity assessed by directing a one-second blast of air onto the exposed buccal root surface of sensitive tooth. Sensitivity will be recorded: 0 = Tooth/Subject does not respond; 1 Tooth/subject responds but does not request discontinuation; 2 Tooth/subject responds and requests discontinuation or moves;3 Tooth/subject responds, considers stimulus to be painful, and requests discontinuation. Each subject will be characterised at each visit by the average of the relevant scores for the two indicator teeth.</description>
        <time_frame>Day 29, 12 hours after product use has ceased</time_frame>
        <group_list>
          <group group_id="O1">
            <title>CSSP Toothpaste</title>
            <description>Toothpaste containing calcium silicate, sodium phosphate and sodium monofluorophosphate. Participants were asked to brush for two minutes with the toothpaste twice per day, morning and evening, using their normal routine. After the evening brush, partipants were instructed to massage a pea sized amount of the toothpaste into the sensitive surfaces of the two selected sensitive teeth for 30 seconds.</description>
          </group>
          <group group_id="O2">
            <title>Fluoride Toothpaste</title>
            <description>Toothpaste containing sodium monofluorphosphate. Participants were asked to brush for two minutes with the toothpaste twice per day, morning and evening, using their normal routine. After the evening brush, partipants were instructed to massage a pea sized amount of the toothpaste into the sensitive surfaces of the two selected sensitive teeth for 30 seconds.</description>
          </group>
        </group_list>
        <measure>
          <title>Thermo-evaporative (Schiff Air Blast) Stimuli</title>
          <description>Air blast sensitivity assessed by directing a one-second blast of air onto the exposed buccal root surface of sensitive tooth. Sensitivity will be recorded: 0 = Tooth/Subject does not respond; 1 Tooth/subject responds but does not request discontinuation; 2 Tooth/subject responds and requests discontinuation or moves;3 Tooth/subject responds, considers stimulus to be painful, and requests discontinuation. Each subject will be characterised at each visit by the average of the relevant scores for the two indicator teeth.</description>
          <units>score 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="125"/>
                <count group_id="O2" value="122"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.188" spread="0.334"/>
                    <measurement group_id="O2" value="2.246" spread="0.329"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29, 12hr after last product use</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.044" spread="0.773"/>
                    <measurement group_id="O2" value="1.713" spread="0.671"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <method_desc>ANOVA model had treatment and gender as factors.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.670</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.850</ci_lower_limit>
            <ci_upper_limit>-0.489</ci_upper_limit>
            <estimate_desc>Difference is first named toothpaste minus second named toothpaste such that a negative value favours the first named toothpaste.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Tactile (Yeaple Probe) Stimuli</title>
        <description>The Yeaple score is recorded in terms of quantified reproducible force (range 10-60 grams with higher values indicating a better outcome). The Yeaple probe tip with a force of 10 grams is passed over the exposed dentin on the buccal surface of the selected teeth, apical to the cementenamel junction and the applied force in increased each time by 10 grams until the participant indicates that he/she is experiencing discomfort, or until 20 grams (baseline) or 60 grams (post product use) of force is reached. A higher value indicates lower levels of dentinal hypersensitivity. Each subject will be characterised at each visit by the average of the relevant scores for the two indicator teeth.</description>
        <time_frame>Day 29, 12 hours after product use has ceased</time_frame>
        <group_list>
          <group group_id="O1">
            <title>CSSP Toothpaste</title>
            <description>Toothpaste containing calcium silicate, sodium phosphate and sodium monofluorophosphate. Participants were asked to brush for two minutes with the toothpaste twice per day, morning and evening, using their normal routine. After the evening brush, partipants were instructed to massage a pea sized amount of the toothpaste into the sensitive surfaces of the two selected sensitive teeth for 30 seconds.</description>
          </group>
          <group group_id="O2">
            <title>Fluoride Toothpaste</title>
            <description>Toothpaste containing sodium monofluorphosphate. Participants were asked to brush for two minutes with the toothpaste twice per day, morning and evening, using their normal routine. After the evening brush, partipants were instructed to massage a pea sized amount of the toothpaste into the sensitive surfaces of the two selected sensitive teeth for 30 seconds.</description>
          </group>
        </group_list>
        <measure>
          <title>Tactile (Yeaple Probe) Stimuli</title>
          <description>The Yeaple score is recorded in terms of quantified reproducible force (range 10-60 grams with higher values indicating a better outcome). The Yeaple probe tip with a force of 10 grams is passed over the exposed dentin on the buccal surface of the selected teeth, apical to the cementenamel junction and the applied force in increased each time by 10 grams until the participant indicates that he/she is experiencing discomfort, or until 20 grams (baseline) or 60 grams (post product use) of force is reached. A higher value indicates lower levels of dentinal hypersensitivity. Each subject will be characterised at each visit by the average of the relevant scores for the two indicator teeth.</description>
          <units>score 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="125"/>
                <count group_id="O2" value="122"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.5" spread="3.46"/>
                    <measurement group_id="O2" value="16.6" spread="3.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29, 12hr after last product use</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.5" spread="14.2"/>
                    <measurement group_id="O2" value="29.7" spread="11.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <method_desc>ANOVA model had treatment and gender as factors.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>11.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>8.6</ci_lower_limit>
            <ci_upper_limit>15.1</ci_upper_limit>
            <estimate_desc>Difference is first named toothpaste minus second named toothpaste such that a positive difference favours first named toothpaste</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Visual Analogue Scale</title>
        <description>Visual Analogue Scale values of the same teeth will be also be recorded to give the outcome variable per subject at the same time of Schiff assessment. The VAS values will be assigned a numerical value in the conventional order from 0 (no pain) to 100 (extremely pain).</description>
        <time_frame>Day 29, 12 hours after product use has ceased</time_frame>
        <group_list>
          <group group_id="O1">
            <title>CSSP Toothpaste</title>
            <description>Toothpaste containing calcium silicate, sodium phosphate and sodium monofluorophosphate. Participants were asked to brush for two minutes with the toothpaste twice per day, morning and evening, using their normal routine. After the evening brush, partipants were instructed to massage a pea sized amount of the toothpaste into the sensitive surfaces of the two selected sensitive teeth for 30 seconds.</description>
          </group>
          <group group_id="O2">
            <title>Fluoride Toothpaste</title>
            <description>Toothpaste containing sodium monofluorphosphate. Participants were asked to brush for two minutes with the toothpaste twice per day, morning and evening, using their normal routine. After the evening brush, partipants were instructed to massage a pea sized amount of the toothpaste into the sensitive surfaces of the two selected sensitive teeth for 30 seconds.</description>
          </group>
        </group_list>
        <measure>
          <title>Visual Analogue Scale</title>
          <description>Visual Analogue Scale values of the same teeth will be also be recorded to give the outcome variable per subject at the same time of Schiff assessment. The VAS values will be assigned a numerical value in the conventional order from 0 (no pain) to 100 (extremely pain).</description>
          <units>score 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="125"/>
                <count group_id="O2" value="122"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.1" spread="20.5"/>
                    <measurement group_id="O2" value="49.9" spread="19.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29, 12hr after last product use</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.2" spread="23.2"/>
                    <measurement group_id="O2" value="38.1" spread="22.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <method_desc>ANOVA model had treatment and gender as factors.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-10.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-16.6</ci_lower_limit>
            <ci_upper_limit>-5.2</ci_upper_limit>
            <estimate_desc>Difference is first named toothpaste minus second named toothpaste such that a negative difference favours the first named toothpaste.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From start of screening until final assessment visit (up to 61 days)</time_frame>
      <desc>Systematic assessment undertaken of oral soft tissues at assessment visits. Non-systematic assessment also used i.e. subject self-report.</desc>
      <group_list>
        <group group_id="E1">
          <title>CSSP Toothpaste</title>
          <description>Toothpaste containing calcium silicate, sodium phosphate and sodium monofluorophosphate. Participants were asked to brush for two minutes with the toothpaste twice per day, morning and evening, using their normal routine. After the evening brush, partipants were instructed to massage a pea sized amount of the toothpaste into the sensitive surfaces of the two selected sensitive teeth for 30 seconds.</description>
        </group>
        <group group_id="E2">
          <title>Fluoride Toothpaste</title>
          <description>Toothpaste containing sodium monofluorphosphate. Participants were asked to brush for two minutes with the toothpaste twice per day, morning and evening, using their normal routine. After the evening brush, partipants were instructed to massage a pea sized amount of the toothpaste into the sensitive surfaces of the two selected sensitive teeth for 30 seconds.</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="132"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="131"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="131"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0.5</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="132"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="131"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cold</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="132"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="131"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="132"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="131"/>
              </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>Dr Jane Matheson</name_or_title>
      <organization>Unilever</organization>
      <phone>+44 (0)1516413633</phone>
      <email>jane.matheson@unilever.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/NCT03244618
org study id: ORL-SEN-2530
nct id: NCT03244618
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Double blind parallel study to measure the efficacy of a toothpaste containing
      calcium-silicate/phosphate on dentinal hypersensitivity compared to a control toothpaste
      containing fluoride
This is a double blind parallel design, with respect to the clinical assessor and subject,
      study. A minimum of 280 (140 per group), male and female subjects will be recruited to ensure
      that a minimum of 200 subjects (100 per group) complete the study. Subjects will attend the
      test site on six (6) occasions.

      Subjects will be screened according to the inclusion and exclusion criteria. Suitable
      subjects will be given a standard fluoride toothpaste and a toothbrush to use for the
      following four to six weeks (Run-in Phase).

      On completion of the run in phase, the subjects will have a baseline sensitivity and soft
      tissue assessments conducted and randomised to product (visit 3).

      Subjects will be randomly assigned to the test groups.

      Subjects will be given sufficient supplies of their allocated toothpaste and a toothbrush to
      use for the following 2 weeks. Instructions for use (IFUs) will be given to the subjects
      along with a toothbrushing diary and an appointment to return to the test site 2 weeks (+/-1
      day) later.

      At the Day 14 visit, subjects will have the dentinal hypersensitivity and soft tissue
      assessments repeated.

      Subjects will be given sufficient supplies of their allocated toothpaste and a toothbrush to
      use for the following 2 weeks. A fresh toothbrushing diary will be given to the subject along
      with an appointment to return to the test site 2 weeks later (Week 4 assessment). Subjects
      will be instructed to brush their teeth as per the IFU for the following 2 weeks.

      At the Day 28 visit subjects will have the dentinal hypersensitivity and soft tissue
      assessments repeated. Prior to leaving the study site, the subjects will be asked to brush
      their teeth as per the IFU. Subjects will be requested to brush their teeth at a specific
      time and return to the study site the following day.

      At the Day 29 visit, subjects will have the dentinal hypersensitivity and soft tissue
      assessments repeated. On completion of the assessments, subjects will receive their
      remuneration for the participating in the study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Thermo-evaporative (Schiff Air Blast) Stimuli
time frame: 4-weeks of product use (Day 28)
description: Air blast sensitivity assessed by directing a one-second blast of air onto the exposed buccal root surface of sensitive tooth. Sensitivity recorded: 0 = Tooth/Subject does not respond; 1 Tooth/subject responds but does not request discontinuation; 2 Tooth/subject responds and requests discontinuation or moves;3 Tooth/subject responds, considers stimulus to be painful, and requests discontinuation. Each subject will be characterised at each visit by the average of the relevant scores for the two indicator teeth. HIgher score is worse outcome.
measure: Tactile (Yeaple Probe) Stimuli
time frame: 4-weeks of product use (Day 28)
description: The Yeaple score is recorded in terms of quantified reproducible force (range 10-60 grams with higher values indicating a better outcome). The Yeaple probe tip with a force of 10 grams is passed over the exposed dentin on the buccal surface of the selected teeth, apical to the cementenamel junction and the applied force in increased each time by 10 grams until the participant indicates that he/she is experiencing discomfort, or until 20 grams (baseline) or 60 grams (post product use) of force is reached. A higher value indicates lower levels of dentinal hypersensitivity. Each subject will be characterised at each visit by the average of the relevant scores for the two indicator teeth.
measure: Visual Analogue Scale
time frame: 4-weeks of product use (Day 28)
description: Visual Analogue Scale values were recorded to give the outcome variable per subject at the same time asSchiff assessment. The VAS values were assigned a numerical value in the conventional order from 0 (no pain) to 100 (extremely pain).
measure: Thermo-evaporative (Schiff Air Blast) Stimuli
time frame: Day 29, 12 hours after product use has ceased
description: Air blast sensitivity assessed by directing a one-second blast of air onto the exposed buccal root surface of sensitive tooth. Sensitivity will be recorded: 0 = Tooth/Subject does not respond; 1 Tooth/subject responds but does not request discontinuation; 2 Tooth/subject responds and requests discontinuation or moves;3 Tooth/subject responds, considers stimulus to be painful, and requests discontinuation. Each subject will be characterised at each visit by the average of the relevant scores for the two indicator teeth.
measure: Tactile (Yeaple Probe) Stimuli
time frame: Day 29, 12 hours after product use has ceased
description: The Yeaple score is recorded in terms of quantified reproducible force (range 10-60 grams with higher values indicating a better outcome). The Yeaple probe tip with a force of 10 grams is passed over the exposed dentin on the buccal surface of the selected teeth, apical to the cementenamel junction and the applied force in increased each time by 10 grams until the participant indicates that he/she is experiencing discomfort, or until 20 grams (baseline) or 60 grams (post product use) of force is reached. A higher value indicates lower levels of dentinal hypersensitivity. Each subject will be characterised at each visit by the average of the relevant scores for the two indicator teeth.
measure: Visual Analogue Scale
time frame: Day 29, 12 hours after product use has ceased
description: Visual Analogue Scale values of the same teeth will be also be recorded to give the outcome variable per subject at the same time of Schiff assessment. The VAS values will be assigned a numerical value in the conventional order from 0 (no pain) to 100 (extremely pain).
arm group label: CSSP Toothpaste
arm group type: Experimental
description: Toothpaste containing Calcium Silicate and Sodium Phosphate
arm group label: Fluoride Toothpaste
arm group type: Placebo Comparator
description: Toothpaste containing Sodium monofluorphosphate
intervention type: Device
intervention name: CSSP Toothpaste
description: Toothpaste containing calcium silicate, sodium phosphate and sodium monofluorophosphate
arm group label: CSSP Toothpaste
intervention type: Device
intervention name: Fluoride Toothpaste
description: Toothpaste containing sodium monofluorphosphate
arm group label: Fluoride Toothpaste
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Nicola X West, Professor
role: Principal Investigator
affiliation: University of Bristol
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Dentin Sensitivity
mesh term: Hypersensitivity
mesh term: Fluorides
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 