<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/NCT03775772</url>
  </required_header>
  <id_info>
    <org_study_id>2017_OrBiD_RCT</org_study_id>
    <nct_id>NCT03775772</nct_id>
  </id_info>
  <brief_title>Oral Health, Bite Force and Dementia</brief_title>
  <acronym>OrBiD</acronym>
  <official_title>Oral Health, Bite Force and Dementia - A Randomized Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Zurich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Zurich</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>
      Study aims: The primary aim is to identify influencing variables on oral hygiene / oral&#xD;
      health and bite force in patients with dementia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 13, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Oral Health (dental examination)</measure>
    <time_frame>1 year</time_frame>
    <description>Decayed, Missing, Filled - Index (dmf/t)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Chewing function I (examination with force gauge meter)</measure>
    <time_frame>1 year</time_frame>
    <description>Bite Force (Bite Force Meter in Newton)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Nutrition I (questionnaire/ assessment of nutritional state)</measure>
    <time_frame>1 year</time_frame>
    <description>Mini Nutritional Assessment (MNA) (Malnutrition present? yes/no/at risk)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nutrition II (examination for weight and body-size)</measure>
    <time_frame>1 year</time_frame>
    <description>Body Mass Index (BMI) (normal weight / under-weight / over-weight)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chewing function II (two-coloured chewing gum to test efficacy)</measure>
    <time_frame>1 year</time_frame>
    <description>Chewing Efficacy (chew two-coloured chewing gum 20 times, visual and optoelectronic evaluation)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Dementia</condition>
  <condition>Oral Hygiene</condition>
  <condition>Chewing Problem</condition>
  <arm_group>
    <arm_group_label>Oral Health - Test Group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>- study population is randomly assigned to control and test group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bite Force/Chewing Efficacy-Test Group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>- study population is randomly assigned to control and test group</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Oral Health</intervention_name>
    <description>test group will receive an dental hygiene program for one year&#xD;
control group will remain with dental hygiene regime like done before study participation (maximum of two dental hygiene Treatments per year)</description>
    <arm_group_label>Oral Health - Test Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Bite Force</intervention_name>
    <description>test group will receive physiotherapy with the aim of increasing muscle strength in chewing muscles for 3 months&#xD;
control group will remain without such training</description>
    <arm_group_label>Bite Force/Chewing Efficacy-Test Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &gt; 59 years&#xD;
&#xD;
          -  no acute processes being present&#xD;
&#xD;
          -  no known cranio-mandibular dysorder (CMD) or finding of any CMD during study&#xD;
             participation&#xD;
&#xD;
          -  non or Maximum of one dental hygiene treatment in the last 12 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  younger than 60 years&#xD;
&#xD;
          -  acute processes in the oral-facial Region&#xD;
&#xD;
          -  known CDM case&#xD;
&#xD;
          -  more than one dental hygiene treatment in the last 12 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Julia Kunze, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Zurich</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Julia Kunze, Dr.</last_name>
    <phone>+41 44 63 43 334</phone>
    <email>julia.kunze@zzm.uzh.ch</email>
  </overall_contact>
  <location>
    <facility>
      <name>Clinic of General, Special Care and Geriatric Dentistry</name>
      <address>
        <city>Zürich</city>
        <zip>5621</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Julia Kunze, Dr.</last_name>
      <phone>+41 44 63 43 334</phone>
      <email>julia.kunze@zzm.uzh.ch</email>
    </contact>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>June 23, 2017</study_first_submitted>
  <study_first_submitted_qc>December 13, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 14, 2018</study_first_posted>
  <last_update_submitted>December 13, 2018</last_update_submitted>
  <last_update_submitted_qc>December 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 14, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>oral health</keyword>
  <keyword>bite force</keyword>
  <keyword>chewing efficiency</keyword>
  <keyword>dementia</keyword>
  <keyword>elderly</keyword>
  <keyword>aged</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dementia</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/NCT03775772
org study id: 2017_OrBiD_RCT
nct id: NCT03775772
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Study aims: The primary aim is to identify influencing variables on oral hygiene / oral
      health and bite force in patients with dementia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Oral Health (dental examination)
time frame: 1 year
description: Decayed, Missing, Filled - Index (dmf/t)
measure: Chewing function I (examination with force gauge meter)
time frame: 1 year
description: Bite Force (Bite Force Meter in Newton)
measure: Nutrition I (questionnaire/ assessment of nutritional state)
time frame: 1 year
description: Mini Nutritional Assessment (MNA) (Malnutrition present? yes/no/at risk)
measure: Nutrition II (examination for weight and body-size)
time frame: 1 year
description: Body Mass Index (BMI) (normal weight / under-weight / over-weight)
measure: Chewing function II (two-coloured chewing gum to test efficacy)
time frame: 1 year
description: Chewing Efficacy (chew two-coloured chewing gum 20 times, visual and optoelectronic evaluation)
arm group label: Oral Health - Test Group
arm group type: Other
description: - study population is randomly assigned to control and test group
arm group label: Bite Force/Chewing Efficacy-Test Group
arm group type: Other
description: - study population is randomly assigned to control and test group
intervention type: Procedure
intervention name: Oral Health
description: test group will receive an dental hygiene program for one year
control group will remain with dental hygiene regime like done before study participation (maximum of two dental hygiene Treatments per year)
arm group label: Oral Health - Test Group
intervention type: Procedure
intervention name: Bite Force
description: test group will receive physiotherapy with the aim of increasing muscle strength in chewing muscles for 3 months
control group will remain without such training
arm group label: Bite Force/Chewing Efficacy-Test Group
criteria: 
gender: All
minimum age: 60 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Julia Kunze, Dr.
role: Principal Investigator
affiliation: University of Zurich
last name: Julia Kunze, Dr.
phone: +41 44 63 43 334
email: julia.kunze@zzm.uzh.ch
facility: 
status: Recruiting
contact: 
country: Switzerland
responsible party type: Sponsor
mesh term: Dementia