<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/NCT03018158</url>
  </required_header>
  <id_info>
    <org_study_id>EC 15-019</org_study_id>
    <nct_id>NCT03018158</nct_id>
  </id_info>
  <brief_title>MR Images Variation With or Without Denture Wear</brief_title>
  <official_title>MR Images Variation With or Without Denture Wear. Motion Artifacts Related With Tongue Movements</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nihon University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nihon University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study was to compare level of artifact while tongue at rest and in&#xD;
      motion of dentulous subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The magnetic resonance imaging (MRI) is useful to diagnose soft tissue morphology, especially&#xD;
      to detect cancer and disk displacement with temporomandibular disorders. The prevalence of&#xD;
      tongue cancer may increase with ageing population. A clear MR image is indispensable for&#xD;
      clinical diagnosis. However, tongue motion associated with the habitual or swallowing tongue&#xD;
      movement may cause artifacts on MRI. This occurrence of motion artifact is speculated to be&#xD;
      prominent with the patients without the occlusal support. The objective of this pilot study&#xD;
      was to compare level of artifact while tongue at rest and in motion of dentulous subjects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">March 2018</completion_date>
  <primary_completion_date type="Actual">March 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Luminance standard deviation value on MR image</measure>
    <time_frame>MR Imaging was collected with each condition.Through study completion, an average of 2 year</time_frame>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Magnetic Resonance Imaging</condition>
  <arm_group>
    <arm_group_label>dentulous</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>MR Imaging was collected with condition at the tongue at rest position.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>edentulous without denture wear.</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>MR Imaging was collected without denture wear.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>edentulous with denture wear.</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MR Imaging was collected with denture wear.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>denture wear.</intervention_name>
    <description>MR Imaging was collected with or without denture wear.</description>
    <arm_group_label>edentulous with denture wear.</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  dentulous&#xD;
&#xD;
          -  edentulous classified Eichner' s classfication&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  involuntary motion occurs during imaging&#xD;
&#xD;
          -  absolutely contraindicated or as a rule contraindicated of MRI examination&#xD;
&#xD;
          -  subjects have ferromagnetic metals in the oral cavity&#xD;
&#xD;
          -  subjects can not swallow naturally&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>100 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 Hospital</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>April 2018</verification_date>
  <study_first_submitted>December 28, 2016</study_first_submitted>
  <study_first_submitted_qc>January 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <last_update_submitted>April 9, 2018</last_update_submitted>
  <last_update_submitted_qc>April 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 11, 2018</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 Dr.Yasuhiko kawai</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03018158
org study id: EC 15-019
nct id: NCT03018158
lead sponsor: 
has dmc: No
The objective of this study was to compare level of artifact while tongue at rest and in
      motion of dentulous subjects.
The magnetic resonance imaging (MRI) is useful to diagnose soft tissue morphology, especially
      to detect cancer and disk displacement with temporomandibular disorders. The prevalence of
      tongue cancer may increase with ageing population. A clear MR image is indispensable for
      clinical diagnosis. However, tongue motion associated with the habitual or swallowing tongue
      movement may cause artifacts on MRI. This occurrence of motion artifact is speculated to be
      prominent with the patients without the occlusal support. The objective of this pilot study
      was to compare level of artifact while tongue at rest and in motion of dentulous subjects.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Luminance standard deviation value on MR image
time frame: MR Imaging was collected with each condition.Through study completion, an average of 2 year
arm group label: dentulous
arm group type: No Intervention
description: MR Imaging was collected with condition at the tongue at rest position.
arm group label: edentulous without denture wear.
arm group type: No Intervention
description: MR Imaging was collected without denture wear.
arm group label: edentulous with denture wear.
arm group type: Experimental
description: MR Imaging was collected with denture wear.
intervention type: Device
intervention name: denture wear.
description: MR Imaging was collected with or without denture wear.
arm group label: edentulous with denture wear.
criteria: 
gender: All
minimum age: 20 Years
maximum age: 100 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 Dr.Yasuhiko kawai
sharing ipd: No