<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/NCT01712802</url>
  </required_header>
  <id_info>
    <org_study_id>KAKEN-24390439</org_study_id>
    <nct_id>NCT01712802</nct_id>
  </id_info>
  <brief_title>Multicenter Study of Denture Adhesive</brief_title>
  <acronym>DAG</acronym>
  <official_title>Multicenter Randomized Clinical Study of Denture Adhesive to Establish the Guideline</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nihon University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Iwate Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tohoku University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tsurumi University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kanagawa Dental University Junior College</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tokyo Medical and Dental University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Osaka Dental University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hiroshima University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Tokushima</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Nagasaki University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kagoshima University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Nihon University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To establish evidence based guidelines for denture adhesives (powder and cream), multicenter&#xD;
      cross over randomized clinical trial will be carried out.&#xD;
&#xD;
      The null hypotheses are that there are no difference on improvement from baseline to post&#xD;
      application of two adhesives powder and cream, in terms of general satisfaction, oral related&#xD;
      quality of life, masticatory function and oral conditions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is multicenter study of 10 academic affiliated institutions. The clinical trial will be&#xD;
      carried out in randomized allocation at each site, and data will be gathered. The&#xD;
      intervention will be 3-arms and center institution (Nihon University) will generate each site&#xD;
      random numbers for allocation and each site will follow this randomization. Research protocol&#xD;
      had been published at Nihon University and distributed to each site.To survey its protocol&#xD;
      compliance, the study meeting will be held periodically (twice an year).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2012</start_date>
  <completion_date type="Actual">March 2017</completion_date>
  <primary_completion_date type="Actual">February 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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>General satisfaction Patient reported outcomes</measure>
    <time_frame>day 3 of adhesives application</time_frame>
    <description>General satisfaction (100mm visual analogue scale)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Moisture Objective outcomes</measure>
    <time_frame>day 3 of each adhesives application</time_frame>
    <description>moisture(%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>masticatory function</measure>
    <time_frame>day 3 of each adhesives application</time_frame>
    <description>Color change of chewing gum measured by color sensing machine (color scale: categorical)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>retentive force</measure>
    <time_frame>day 3 of each adhesives application</time_frame>
    <description>The maximum occlusal force that can bite before denture moves(N)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oral related quality of life</measure>
    <time_frame>day 3 of adhesives application</time_frame>
    <description>Oral health impact profile (OHIP) edentulous Japanese version</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Edentulous</condition>
  <arm_group>
    <arm_group_label>Denture Adhesives: Cream</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Parallel arm that receives application of Cream denture adhesives.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Denture Adhesives: Powder</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Parallel arm that receives application of powder denture adhesive.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Parallel arm that receive placebo.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Denture Adhesives: Cream</intervention_name>
    <description>Using Polident as denture adhesive to compare its effect on PRO and subjective outcomes.</description>
    <arm_group_label>Denture Adhesives: Cream</arm_group_label>
    <other_name>Polident</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Denture Adhesives: Powder</intervention_name>
    <description>Using Poligrip powder as denture adhesive to compare its effect on PRO and subjective outcomes.</description>
    <arm_group_label>Denture Adhesives: Powder</arm_group_label>
    <other_name>Poligrip powder</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Saline</intervention_name>
    <description>work as control for Denture Adhesives: Cream and Powder</description>
    <arm_group_label>control</arm_group_label>
    <other_name>Otsuka normal saline</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  edentulous&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cannot answer the questionnaire&#xD;
&#xD;
          -  Deteriorating general conditions&#xD;
&#xD;
          -  Maxillofacial defect&#xD;
&#xD;
          -  Metal denture user&#xD;
&#xD;
          -  Already denture adhesive users&#xD;
&#xD;
          -  Severe xerostomia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yasuhiko Kawai, DDS MSc PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Nihon University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nihon University</name>
      <address>
        <city>Matsudo</city>
        <state>Chiba</state>
        <zip>2718587</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>October 17, 2012</study_first_submitted>
  <study_first_submitted_qc>October 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 24, 2012</study_first_posted>
  <last_update_submitted>March 27, 2017</last_update_submitted>
  <last_update_submitted_qc>March 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nihon University</investigator_affiliation>
    <investigator_full_name>Yasuhiko Kawai</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mouth, Edentulous</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT01712802
org study id: KAKEN-24390439
nct id: NCT01712802
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
To establish evidence based guidelines for denture adhesives (powder and cream), multicenter
      cross over randomized clinical trial will be carried out.

      The null hypotheses are that there are no difference on improvement from baseline to post
      application of two adhesives powder and cream, in terms of general satisfaction, oral related
      quality of life, masticatory function and oral conditions.
This is multicenter study of 10 academic affiliated institutions. The clinical trial will be
      carried out in randomized allocation at each site, and data will be gathered. The
      intervention will be 3-arms and center institution (Nihon University) will generate each site
      random numbers for allocation and each site will follow this randomization. Research protocol
      had been published at Nihon University and distributed to each site.To survey its protocol
      compliance, the study meeting will be held periodically (twice an year).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: General satisfaction Patient reported outcomes
time frame: day 3 of adhesives application
description: General satisfaction (100mm visual analogue scale)
measure: Moisture Objective outcomes
time frame: day 3 of each adhesives application
description: moisture(%)
measure: masticatory function
time frame: day 3 of each adhesives application
description: Color change of chewing gum measured by color sensing machine (color scale: categorical)
measure: retentive force
time frame: day 3 of each adhesives application
description: The maximum occlusal force that can bite before denture moves(N)
measure: Oral related quality of life
time frame: day 3 of adhesives application
description: Oral health impact profile (OHIP) edentulous Japanese version
arm group label: Denture Adhesives: Cream
arm group type: Experimental
description: Parallel arm that receives application of Cream denture adhesives.
arm group label: Denture Adhesives: Powder
arm group type: Experimental
description: Parallel arm that receives application of powder denture adhesive.
arm group label: control
arm group type: Placebo Comparator
description: Parallel arm that receive placebo.
intervention type: Other
intervention name: Denture Adhesives: Cream
description: Using Polident as denture adhesive to compare its effect on PRO and subjective outcomes.
arm group label: Denture Adhesives: Cream
other name: Polident
intervention type: Other
intervention name: Denture Adhesives: Powder
description: Using Poligrip powder as denture adhesive to compare its effect on PRO and subjective outcomes.
arm group label: Denture Adhesives: Powder
other name: Poligrip powder
intervention type: Other
intervention name: Saline
description: work as control for Denture Adhesives: Cream and Powder
arm group label: control
other name: Otsuka normal saline
criteria: 
gender: All
minimum age: 50 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yasuhiko Kawai, DDS MSc PhD
role: Study Chair
affiliation: Nihon University
facility: 
country: Japan
responsible party type: Principal Investigator
investigator affiliation: Nihon University
investigator full name: Yasuhiko Kawai
investigator title: Professor
mesh term: Mouth, Edentulous