<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/NCT03037307</url>
  </required_header>
  <id_info>
    <org_study_id>207545</org_study_id>
    <nct_id>NCT03037307</nct_id>
  </id_info>
  <brief_title>A Clinical Bite Force Study of Two Marketed Adhesives Against no Adhesive</brief_title>
  <official_title>A Bite Force Study Assessing Two Currently Marketed Denture Adhesive Products Compared to No-Adhesive Control</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</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>
      The objective of this study will be to compare bite force (BF) measurements over a 12-hour&#xD;
      period of a currently marketed denture adhesive cream based on carbomer technology (test),&#xD;
      with a positive control and a negative/no treatment control.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This will be a single centre, randomized, crossover, 3-treatment, 3-period study to compare&#xD;
      BF measurements over a 12 hour period of a currently marketed denture adhesive cream based on&#xD;
      carbomer technology (test), with a positive control, and a negative/no treatment control. A&#xD;
      short questionnaire regarding the flavor and texture characteristics of each denture adhesive&#xD;
      after a single use will also be used to generate data for these attributes. This study&#xD;
      included four visits: Visit 1 (screening visit), Visit 2, 3, 4 (treatment visits).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 13, 2017</start_date>
  <completion_date type="Actual">May 4, 2017</completion_date>
  <primary_completion_date type="Actual">May 4, 2017</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area Over Baseline Over 12 Hours (AOB0-12) for the Incisal Bite Force (Positive Control Adhesive Versus [vs.] Negative Control)</measure>
    <time_frame>Up to 12 hours</time_frame>
    <description>Area over baseline over 12 hours (AOB0-12) was assessed to measure the incisal bite force. AOB0-12 was calculated as area under the curve over 12 hours [AUC0-12])/12 hours minus baseline bite force (pounds [lbs]). AUC0-12 was calculated using the trapezoidal method. This transformation returned the measurement to the same scale as the original observations. Higher values of AOB0-12 demonstrate a stronger bite force overtime than lower values.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Over Baseline Over 12 Hours (AOB0-12) for the Incisal Bite Force (Test Adhesive vs. Negative Control)</measure>
    <time_frame>Up to 12 hours</time_frame>
    <description>Area over baseline over 12 hours (AOB0-12) was assessed to measure the incisal bite force. AOB0-12 was calculated as area under the curve over 12 hours [AUC0-12])/12 hours minus baseline bite force (lbs). AUC0-12 was calculated using the trapezoidal method. This transformation returned the measurement to the same scale as the original observations. Higher values of AOB0-12 demonstrate a stronger bite force overtime than lower values.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Denture Retention</condition>
  <arm_group>
    <arm_group_label>Test product</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will topically apply the test product to clean wet denture (upper denture) fit surface in a pattern consistent with product label and application instructions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Positive Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will topically apply the positive control to clean wet denture (upper denture) fit surface in a pattern consistent with product label and application instructions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Negative Control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants of this group will not be assigned to any treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Test Product</intervention_name>
    <description>Five strips of test adhesive cream for upper denture, as per application instructions.</description>
    <arm_group_label>Test product</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Positive Contol</intervention_name>
    <description>Three dabs of positive control adhesive cream for upper denture, as per application instructions.</description>
    <arm_group_label>Positive Control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Negative Control</intervention_name>
    <description>No adhesive</description>
    <arm_group_label>Negative Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Demonstrates understanding of the study procedures, restrictions and willingness to&#xD;
             participate as evidenced by voluntary written informed consent and has received a&#xD;
             signed and dated copy of the informed consent form.&#xD;
&#xD;
          -  Aged between 18 to 85 years.&#xD;
&#xD;
          -  Good general and mental health with, in the opinion of the investigator or medically&#xD;
             qualified designee: No clinically significant and relevant abnormalities in medical&#xD;
             history or upon oral examination; absence of any condition that could affect the&#xD;
             participant's safety or wellbeing or their ability to understand and follow study&#xD;
             procedures and requirements.&#xD;
&#xD;
          -  Diagnosis: a) Completely edentulous maxillary arch restored with a conventional full&#xD;
             acrylic based upper complete denture, b) Dentate, partial or full edentulous&#xD;
             mandibular arch. Partial or full edentulous arch may be restored with a stable&#xD;
             complete, partial or implant supported denture, c) Maxillary dentures must be&#xD;
             considered to be moderately well-fitting at the screening visit (Kapur Index, Olshan&#xD;
             Modification: retention score &gt;2, stability score &gt;2) d) Maxillary dentures and&#xD;
             mandibular dentures, if present, must be considered to be well-made based on design&#xD;
             and construction criteria specified in the protocol e) The qualifying maxillary&#xD;
             incisal BF readings (without adhesive) must be less than or equal to 9 pounds at the&#xD;
             Screening Visit and subsequent visit pretreatment baseline bites. f) At least 2 of the&#xD;
             4 qualifying bite readings at the Screening Visit must be reproducible (+2lb). At&#xD;
             subsequent visits the bite force readings must be within +2lb for 1 of the 3 practice&#xD;
             bites and the pre-treatment baseline bite.&#xD;
&#xD;
          -  Understands and is willing, able and likely to comply with all study procedures and&#xD;
             restrictions.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A woman who is known to be pregnant or who is intending to become pregnant&#xD;
             (self-reported) over the duration of the study.&#xD;
&#xD;
          -  A woman who is breast-feeding.&#xD;
&#xD;
          -  a) Implanted with a cardiac pacemaker, b) Daily doses of medication that might&#xD;
             interfere with the ability to perform the study according to protocol (as determined&#xD;
             by the Investigator), c) Insulin dependent diabetics, d) Taking or have taken a&#xD;
             bisphosphonate drug for treatment of osteoporosis, e) A serious chronic disease&#xD;
             requiring hospitalization, f) Any condition not previously mentioned that in the&#xD;
             Investigator's opinion may impair the study evaluation.&#xD;
&#xD;
          -  Known or suspected intolerance or hypersensitivity to the study materials (or closely&#xD;
             related compounds) or any of their stated ingredients.&#xD;
&#xD;
          -  a) Any clinically significant or relevant oral abnormality (e.g. temporomandibular&#xD;
             joint [TMJ] problems) that, in the opinion of the investigator, could affect the&#xD;
             participant's participation in the study, b) Any participant clinically identified as&#xD;
             having an incisal bite relation which could affect the bite force measurements, c)&#xD;
             Severe dry mouth that may affect denture retention in the opinion of the Investigator,&#xD;
             d) OST examination findings such as stomatitis, open sores, lesions, redness or&#xD;
             swelling that, in the opinion of the investigator, could affect the participant's&#xD;
             participation in the study. e) A serious chronic disease requiring hospitalization. f)&#xD;
             Any condition not previously mentioned that in the Investigator's opinion may impair&#xD;
             the study evaluation.&#xD;
&#xD;
          -  Known or suspected intolerance or hypersensitivity to the study materials (or closely&#xD;
             related compounds) or any of their stated ingredients.&#xD;
&#xD;
          -  a) Any clinically significant or relevant oral abnormality (e.g. temporomandibular&#xD;
             joint [TMJ] problems) that, in the opinion of the investigator, could affect the&#xD;
             participant's participation in the study, b) Any participant clinically identified as&#xD;
             having an incisal bite relation which could affect the bite force measurements, c)&#xD;
             Severe dry mouth that may affect denture retention in the opinion of the Investigator,&#xD;
             d) OST examination findings such as stomatitis, open sores, lesions, redness or&#xD;
             swelling that, in the opinion of the investigator, could affect the participant's&#xD;
             participation in the study.&#xD;
&#xD;
          -  a) Participation in another clinical study (including cosmetic studies) or receipt of&#xD;
             an investigational drug within 30 days of the screening visit, b) Previous&#xD;
             participation in this study.&#xD;
&#xD;
          -  Recent history (within the last year) of alcohol or other substance abuse.&#xD;
&#xD;
          -  A participant who is unwilling to refrain from smoking, including e-cigarettes and the&#xD;
             use of chewing tobacco or other tobacco products for the duration of screening and&#xD;
             each treatment day (12-14 hours).&#xD;
&#xD;
          -  An employee of the sponsor or the study site or members of their immediate family.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>January 27, 2017</study_first_submitted>
  <study_first_submitted_qc>January 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <results_first_submitted>April 20, 2018</results_first_submitted>
  <results_first_submitted_qc>June 15, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">August 31, 2018</results_first_posted>
  <last_update_submitted>June 15, 2018</last_update_submitted>
  <last_update_submitted_qc>June 15, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 17, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/07/NCT03037307/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 9, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/07/NCT03037307/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>All participants were recruited at a single center in the United States.</recruitment_details>
      <pre_assignment_details>A total of 53 participants were screened. Out of which 44 participants were randomized in the study. 9 participants were not randomized because they did not meet the study criteria.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Test Adhesive/No Treatment/Positive Control Adhesive</title>
          <description>Participants in this arm received topical application of test adhesive, followed by no treatment, positive control adhesive in Period 1, 2 and 3 respectively. Each treatment period was separated by a wash out period of at least 24 hours up to 14 days. Study products were applied by site study staff, to clean wet denture (upper denture) fit surface in a pattern consistent with product label and application instructions.</description>
        </group>
        <group group_id="P2">
          <title>Test Adhesive/Positive Control Adhesive/No Treatment</title>
          <description>Participants in this arm received topical application of test adhesive, followed by positive control adhesive and no treatment in Period 1, 2 and 3 respectively. Each treatment period was separated by a wash out period of at least 24 hours up to 14 days. Study products was applied by site study staff, to clean wet denture (upper denture) fit surface in a pattern consistent with product label and application instructions.</description>
        </group>
        <group group_id="P3">
          <title>No Treatment/Test Adhesive/Positive Control Adhesive</title>
          <description>Participants in this arm received no treatment, followed by topical application of test adhesive and positive control adhesive in Period 1, 2 and 3 respectively. Each treatment period was separated by a wash out period of at least 24 hours up to 14 days. Study products was applied by site study staff, to clean wet denture (upper denture) fit surface in a pattern consistent with product label and application instructions.</description>
        </group>
        <group group_id="P4">
          <title>No Treatment/Positive Control Adhesive/Test Adhesive</title>
          <description>Participants in this arm received no treatment, followed by topical application of positive control adhesive and test adhesive in Period 1, 2 and 3 respectively. Each treatment period was separated by a wash out period of at least 24 hours up to 14 days. Study products was applied by site study staff, to clean wet denture (upper denture) fit surface in a pattern consistent with product label and application instructions.</description>
        </group>
        <group group_id="P5">
          <title>Positive Control Adhesive/Test Adhesive/No Treatment</title>
          <description>Participants in this arm received topical application of positive control adhesive, followed by test adhesive and no treatment in Period 1, 2 and 3 respectively. Each treatment period was separated by a wash out period of at least 24 hours up to 14 days. Study products was applied by site study staff, to clean wet denture (upper denture) fit surface in a pattern consistent with product label and application instructions.</description>
        </group>
        <group group_id="P6">
          <title>Positive Control Adhesive/No Treatment/Test Adhesive</title>
          <description>Participants in this arm received topical application of positive control adhesive, followed by no treatment and test adhesive in Period 1, 2 and 3 respectively. Each treatment period was separated by a wash out period of at least 24 hours up to 14 days. Study products was applied by site study staff, to clean wet denture (upper denture) fit surface in a pattern consistent with product label and application instructions.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Period 1</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="7"/>
                <participants group_id="P5" count="7"/>
                <participants group_id="P6" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="7"/>
                <participants group_id="P6" count="8"/>
              </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 group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Did Not Meet Study Criteria</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Wash Out Period 1</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="7"/>
                <participants group_id="P6" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="7"/>
                <participants group_id="P6" count="8"/>
              </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 group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Period 2</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="7"/>
                <participants group_id="P6" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="7"/>
                <participants group_id="P6" count="8"/>
              </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 group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Wash Out Period 2</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="7"/>
                <participants group_id="P6" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="7"/>
                <participants group_id="P6" count="8"/>
              </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 group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Period 3</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="7"/>
                <participants group_id="P6" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="7"/>
                <participants group_id="P6" count="8"/>
              </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 group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Overall Study Participants</title>
          <description>All randomized participants who received test adhesive, positive control adhesive and did not receive any treatment were included in the baseline assessment.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="44"/>
          </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="67.0" spread="9.39"/>
                  </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="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Area Over Baseline Over 12 Hours (AOB0-12) for the Incisal Bite Force (Positive Control Adhesive Versus [vs.] Negative Control)</title>
        <description>Area over baseline over 12 hours (AOB0-12) was assessed to measure the incisal bite force. AOB0-12 was calculated as area under the curve over 12 hours [AUC0-12])/12 hours minus baseline bite force (pounds [lbs]). AUC0-12 was calculated using the trapezoidal method. This transformation returned the measurement to the same scale as the original observations. Higher values of AOB0-12 demonstrate a stronger bite force overtime than lower values.</description>
        <time_frame>Up to 12 hours</time_frame>
        <population>Analysis for this outcome was performed on intention-to-treat (ITT) population which included all randomized participants with at least one post baseline assessment of efficacy.</population>
        <group_list>
          <group group_id="O1">
            <title>Positive Control Adhesive</title>
            <description>Participants of this arm received topical application of positive control adhesive (super poligrip free, commercially available) by site study staff, to clean wet denture (upper denture) fit surface in a pattern consistent with product label and application instructions.</description>
          </group>
          <group group_id="O2">
            <title>Negative Control</title>
            <description>Participants of this arm did not receive any adhesive to apply on upper denture.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Over Baseline Over 12 Hours (AOB0-12) for the Incisal Bite Force (Positive Control Adhesive Versus [vs.] Negative Control)</title>
          <description>Area over baseline over 12 hours (AOB0-12) was assessed to measure the incisal bite force. AOB0-12 was calculated as area under the curve over 12 hours [AUC0-12])/12 hours minus baseline bite force (pounds [lbs]). AUC0-12 was calculated using the trapezoidal method. This transformation returned the measurement to the same scale as the original observations. Higher values of AOB0-12 demonstrate a stronger bite force overtime than lower values.</description>
          <population>Analysis for this outcome was performed on intention-to-treat (ITT) population which included all randomized participants with at least one post baseline assessment of efficacy.</population>
          <units>lbs</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.78" spread="0.657"/>
                    <measurement group_id="O2" value="2.03" spread="0.657"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <p_value_desc>Treatment Comparison for study validity.</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>ANCOVA: factors for participant (random effect); period &amp; treatment, participant-level &amp; period-level pre-treatment baseline bite force as covariates.</method_desc>
            <param_type>Least square (LS) mean difference</param_type>
            <param_value>2.76</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.89</ci_lower_limit>
            <ci_upper_limit>3.63</ci_upper_limit>
            <estimate_desc>Difference is first-named treatment minus second-named treatment such that a positive difference favours the first named treatment.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Area Over Baseline Over 12 Hours (AOB0-12) for the Incisal Bite Force (Test Adhesive vs. Negative Control)</title>
        <description>Area over baseline over 12 hours (AOB0-12) was assessed to measure the incisal bite force. AOB0-12 was calculated as area under the curve over 12 hours [AUC0-12])/12 hours minus baseline bite force (lbs). AUC0-12 was calculated using the trapezoidal method. This transformation returned the measurement to the same scale as the original observations. Higher values of AOB0-12 demonstrate a stronger bite force overtime than lower values.</description>
        <time_frame>Up to 12 hours</time_frame>
        <population>Analysis for this outcome was performed on ITT population which included all randomized participants with at least one post baseline assessment of efficacy.</population>
        <group_list>
          <group group_id="O1">
            <title>Test Adhesive</title>
            <description>Participants of this arm received topical application of test adhesive (commercially available) by site study staff, to clean wet denture (upper denture) fit surface in a pattern consistent with product label and application instructions.</description>
          </group>
          <group group_id="O2">
            <title>Negative Control</title>
            <description>Participants of this arm did not receive any adhesive to apply on upper denture.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Over Baseline Over 12 Hours (AOB0-12) for the Incisal Bite Force (Test Adhesive vs. Negative Control)</title>
          <description>Area over baseline over 12 hours (AOB0-12) was assessed to measure the incisal bite force. AOB0-12 was calculated as area under the curve over 12 hours [AUC0-12])/12 hours minus baseline bite force (lbs). AUC0-12 was calculated using the trapezoidal method. This transformation returned the measurement to the same scale as the original observations. Higher values of AOB0-12 demonstrate a stronger bite force overtime than lower values.</description>
          <population>Analysis for this outcome was performed on ITT population which included all randomized participants with at least one post baseline assessment of efficacy.</population>
          <units>lbs</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.15" spread="0.659"/>
                    <measurement group_id="O2" value="2.03" spread="0.657"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <method>ANCOVA</method>
            <method_desc>ANCOVA: factors for participant (random effect); period &amp; treatment, participant-level &amp; period-level pre-treatment baseline bite force as covariates</method_desc>
            <param_type>Least Square (LS) mean difference</param_type>
            <param_value>2.12</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.25</ci_lower_limit>
            <ci_upper_limit>3.00</ci_upper_limit>
            <estimate_desc>Difference is first-named treatment minus second-named treatment such that a positive difference favours the first named treatment.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>up to 51 days (AEs were collected from OST examination from screening until 5 days following last administration of study product on Visit 4)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Test Adhesive</title>
          <description>Participants of this arm received topical application of test adhesive (commercially available) by site study staff, to clean wet denture (upper denture) fit surface in a pattern consistent with product label and application instructions.</description>
        </group>
        <group group_id="E2">
          <title>Positive Control Adhesive</title>
          <description>Participants of this arm received topical application of positive control adhesive (super poligrip free, commercially available) by site study staff, to clean wet denture (upper denture) fit surface in a pattern consistent with product label and application instructions.</description>
        </group>
        <group group_id="E3">
          <title>Negative Control</title>
          <description>Participants of this arm did not receive any adhesive to apply on upper denture.</description>
        </group>
        <group group_id="E4">
          <title>Overall Participants</title>
          <description>This arm included all the participants randomized to receive test adhesive, positive control adhesive and no treatment.</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="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="43"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gingival erythema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Oral mucosal erythema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Medical device pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Mouth injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>GSK Response Center</name_or_title>
      <organization>GlaxoSmithKline</organization>
      <phone>866-435-7343</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03037307
org study id: 207545
nct id: NCT03037307
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The objective of this study will be to compare bite force (BF) measurements over a 12-hour
      period of a currently marketed denture adhesive cream based on carbomer technology (test),
      with a positive control and a negative/no treatment control.
This will be a single centre, randomized, crossover, 3-treatment, 3-period study to compare
      BF measurements over a 12 hour period of a currently marketed denture adhesive cream based on
      carbomer technology (test), with a positive control, and a negative/no treatment control. A
      short questionnaire regarding the flavor and texture characteristics of each denture adhesive
      after a single use will also be used to generate data for these attributes. This study
      included four visits: Visit 1 (screening visit), Visit 2, 3, 4 (treatment visits).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Area Over Baseline Over 12 Hours (AOB0-12) for the Incisal Bite Force (Positive Control Adhesive Versus [vs.] Negative Control)
time frame: Up to 12 hours
description: Area over baseline over 12 hours (AOB0-12) was assessed to measure the incisal bite force. AOB0-12 was calculated as area under the curve over 12 hours [AUC0-12])/12 hours minus baseline bite force (pounds [lbs]). AUC0-12 was calculated using the trapezoidal method. This transformation returned the measurement to the same scale as the original observations. Higher values of AOB0-12 demonstrate a stronger bite force overtime than lower values.
measure: Area Over Baseline Over 12 Hours (AOB0-12) for the Incisal Bite Force (Test Adhesive vs. Negative Control)
time frame: Up to 12 hours
description: Area over baseline over 12 hours (AOB0-12) was assessed to measure the incisal bite force. AOB0-12 was calculated as area under the curve over 12 hours [AUC0-12])/12 hours minus baseline bite force (lbs). AUC0-12 was calculated using the trapezoidal method. This transformation returned the measurement to the same scale as the original observations. Higher values of AOB0-12 demonstrate a stronger bite force overtime than lower values.
arm group label: Test product
arm group type: Experimental
description: Participants will topically apply the test product to clean wet denture (upper denture) fit surface in a pattern consistent with product label and application instructions.
arm group label: Positive Control
arm group type: Active Comparator
description: Participants will topically apply the positive control to clean wet denture (upper denture) fit surface in a pattern consistent with product label and application instructions.
arm group label: Negative Control
arm group type: Other
description: Participants of this group will not be assigned to any treatment.
intervention type: Other
intervention name: Test Product
description: Five strips of test adhesive cream for upper denture, as per application instructions.
arm group label: Test product
intervention type: Other
intervention name: Positive Contol
description: Three dabs of positive control adhesive cream for upper denture, as per application instructions.
arm group label: Positive Control
intervention type: Other
intervention name: Negative Control
description: No adhesive
arm group label: Negative Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
facility: 
country: United States
responsible party type: Sponsor
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 