xml: <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/NCT06011564</url>
    </required_header>
    <id_info>
      <org_study_id>BTH-6.1.1-0059-2016</org_study_id>
      <nct_id>NCT06011564</nct_id>
    </id_info>
    <brief_title>eDENT Oral Health- the Gateway to Quality of Care and Everyday Life at Old Age</brief_title>
    <official_title>eDENT Oral Health- the Gateway to Quality of Care and Everyday Life at Old Age</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Blekinge Institute of Technology</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Kristianstad University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Blekinge Institute of Technology</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The investigators will present a new strategy for working with oral health for the group of&#xD;
        elderly people with various degrees of mild cognitive impairments. The investigators hope&#xD;
        that by introducing a powered toothbrush with functions that make it possible to remind and&#xD;
        gather information about the use, the investigators will primarily facilitate oral care for&#xD;
        this group, and are proposing that this will lead to higher quality of life of the persons&#xD;
        involved.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The investigators will present a new strategy for working with oral health for the group of&#xD;
        elderly people with various degrees of mild cognitive impairments. The investigators hope&#xD;
        that by introducing a powered toothbrush with functions that make it possible to remind and&#xD;
        gather information about use, the investigators will primarily facilitate oral care for this&#xD;
        group, and are proposing that this will lead to higher quality of life of the persons&#xD;
        involved. Secondarily this will have great impact on the care/carer situation as well as the&#xD;
        need for reactive dental care. Expected results is to see both how the actual reminders can&#xD;
        be designed in order to accommodate for this group, the context of how these reminders can be&#xD;
        used and ultimately if this has an impact on oral health for the group of elderly people with&#xD;
        various degrees of mild cognitive impairments.&#xD;
  &#xD;
        With age, functional decline occurs and the incidence and prevalence of chronic diseases&#xD;
        increase, so aging is an important risk for developing medical conditions. Along with age,&#xD;
        the prevalence of dementia increases significantly.&#xD;
  &#xD;
        Persons with dementia show a higher prevalence of coronal and root caries and present more&#xD;
        often with root remnants as the utilization of dental services becomes scarce. Patients with&#xD;
        dementia had an increased likelihood of tooth loss and untreated caries, as well as&#xD;
  &#xD;
        presenting with poor oral and denture hygiene compared with non-demented persons. In the&#xD;
        initial stages of the disease, this condition may be related to a shift in priorities and a&#xD;
        reluctance to brush the teeth. In addition, there is the inability to accurately perform oral&#xD;
        hygiene measures due to poor motor skills and sacropenia, especially of the hand-grip&#xD;
        strength, render oral hygiene measures more difficult to perform. When the disease&#xD;
        progresses, patients will become increasingly dependent on supervision/assistance on oral&#xD;
        hygiene procedures. Co-operation is required when a carer has to perform oral hygiene&#xD;
        measures and access to the mouth has to be granted. Poor oral hygiene and the presence of&#xD;
        abundant biofilm fosters periodontal disease and caries. Combined with a shift in dietary&#xD;
        intake towards more sweet food-stuffs the risk factors for developing carious lesions&#xD;
        increases significantly. The risk of caries is further increased as result of a decreased&#xD;
        salivary flow due to medication intake.&#xD;
  &#xD;
        Previous research has demonstrated that the use of a powered toothbrush instead of a manual&#xD;
        one reduces plaque and gingivitis more effectively than manual toothbrushes . The reduction&#xD;
        of gingivitis using an electric toothbrush as compared to a manual one is reported to be in&#xD;
        the range of 11 to 17%. According to the American Dental association tooth brushing should be&#xD;
        performed twice daily for two minutes each time. On average it is estimated that people brush&#xD;
        their teeth for less than a minute per day. The efficacy of a toothbrush is highly dependent&#xD;
        on how long time the individual is actually using the device and it can be anticipated that&#xD;
        individuals with mild cognitive impairment may forget to use the tooth brush on a daily basis&#xD;
        and also that whenever using the brush the time spent may be even shorter than 30 seconds&#xD;
        each time. The control group will be supplied with a powered toothbrush only and instructed&#xD;
        to use any other means of tooth cleaning (ie. interdental cleaning) as before. It is&#xD;
        anticipated that a temporary improvement of oral hygiene will occur in the control group, but&#xD;
        the temporary improvement may not be sustainable among individuals with mild cognitive&#xD;
        impairment. Accordingly, there will not be an added benefit for either the individual or the&#xD;
        society only to supply individuals with cognitive impairment with a powered toothbrush.&#xD;
  &#xD;
        In the test group, individuals are supplied with a powered toothbrush and a tablet with&#xD;
        reminder functions. It is anticipated that the brush will be used more frequently and&#xD;
        possibly also for longer periods compared to the group without such reminder functions,&#xD;
        resulting in &gt;30% improvement compared to the control group.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">June 1, 2018</start_date>
    <completion_date type="Actual">January 15, 2023</completion_date>
    <primary_completion_date type="Actual">January 15, 2023</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>
      <intervention_model_description>RCT</intervention_model_description>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in the amount of dental plaque</measure>
      <time_frame>From baseline, to month 6, and to month 12, and to month 24, and to month 36</time_frame>
      <description>Presence of dental plaque measured on four of the tooth surfaces presented as a percentage</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in the amount of gingival bleeding on probing</measure>
      <time_frame>From baseline, to month 6, and to month 12, and to month 24, and to month 36</time_frame>
      <description>Number of bleeding from the gingiva measured on four sides of the teeth presented as a percentage</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in the number of periodontal pockets 4 mm or deeper</measure>
      <time_frame>From baseline, to month 6, and to month 12, and to month 24, and to month 36</time_frame>
      <description>The number of periodontal pockets 4 mm or deeper measured on four of the tooth surfaces presented as a percentage</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in values for the quality of life instrument QoL-AD</measure>
      <time_frame>From baseline, to month 6, and to month 12, and to month 24, and to month 36</time_frame>
      <description>The value for the quality of life instrument QoL-AD (Quality of Life Alzheimer Disease) is measured on a scale from 0-30, where 30 corresponds to the highest quality of life</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in values for the oral health related quality of life instrument OHIP-14</measure>
      <time_frame>From baseline, to month 6, and to month 12, and to month 24, and to month 36</time_frame>
      <description>The value for the oral health-related quality of life instrument OHIP-14 (Oral Health Impact Profile-14) is measured on a scale from 0-56 where 0 corresponds to the highest quality of life</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">213</enrollment>
    <condition>Mild Cognitive Impairment</condition>
    <condition>Gingivitis</condition>
    <condition>Periodontal Diseases</condition>
    <arm_group>
      <arm_group_label>Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Reminder function</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>No reminder</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Reminder function on Android computer tablet</intervention_name>
      <description>Computer tablet with reminder function</description>
      <arm_group_label>Intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Being 55 years or older&#xD;
  &#xD;
            -  Having experienced memory problems in the last six months before inclusion&#xD;
  &#xD;
            -  Having a Mini-Mental State Examination score of 20-28&#xD;
  &#xD;
            -  Are not receiving any formal care&#xD;
  &#xD;
            -  Having at least ten teeth of their own&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Having a terminal illness with less than three years of expected survival&#xD;
  &#xD;
            -  Having another known significant cause of disease explaining cognitive impairment&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>55 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Johan Sanmartin-Berglund, Professor</last_name>
      <role>Study Chair</role>
      <affiliation>Blekinge Institute of Technology</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Blekinge Institute of Technology</name>
        <address>
          <city>Karlskrona</city>
          <zip>37179</zip>
          <country>Sweden</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Sweden</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 12, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Mild Cognitive Impairment</keyword>
    <keyword>Oral Health</keyword>
    <keyword>Quality of Life</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Gingivitis</mesh_term>
      <mesh_term>Periodontal Diseases</mesh_term>
      <mesh_term>Cognitive Dysfunction</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>The trial protocol and the datasets used and analyzed during the current study are available upon reasonable request.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_time_frame>From 2023-06-12</ipd_time_frame>
      <ipd_access_criteria>The trial protocol and the datasets used and analyzed during the current study are available upon reasonable request.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06011564
  org study id: BTH-6.1.1-0059-2016
  nct id: NCT06011564
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The investigators will present a new strategy for working with oral health for the group of
        elderly people with various degrees of mild cognitive impairments. The investigators hope
        that by introducing a powered toothbrush with functions that make it possible to remind and
        gather information about the use, the investigators will primarily facilitate oral care for
        this group, and are proposing that this will lead to higher quality of life of the persons
        involved.
  The investigators will present a new strategy for working with oral health for the group of
        elderly people with various degrees of mild cognitive impairments. The investigators hope
        that by introducing a powered toothbrush with functions that make it possible to remind and
        gather information about use, the investigators will primarily facilitate oral care for this
        group, and are proposing that this will lead to higher quality of life of the persons
        involved. Secondarily this will have great impact on the care/carer situation as well as the
        need for reactive dental care. Expected results is to see both how the actual reminders can
        be designed in order to accommodate for this group, the context of how these reminders can be
        used and ultimately if this has an impact on oral health for the group of elderly people with
        various degrees of mild cognitive impairments.
  
        With age, functional decline occurs and the incidence and prevalence of chronic diseases
        increase, so aging is an important risk for developing medical conditions. Along with age,
        the prevalence of dementia increases significantly.
  
        Persons with dementia show a higher prevalence of coronal and root caries and present more
        often with root remnants as the utilization of dental services becomes scarce. Patients with
        dementia had an increased likelihood of tooth loss and untreated caries, as well as
  
        presenting with poor oral and denture hygiene compared with non-demented persons. In the
        initial stages of the disease, this condition may be related to a shift in priorities and a
        reluctance to brush the teeth. In addition, there is the inability to accurately perform oral
        hygiene measures due to poor motor skills and sacropenia, especially of the hand-grip
        strength, render oral hygiene measures more difficult to perform. When the disease
        progresses, patients will become increasingly dependent on supervision/assistance on oral
        hygiene procedures. Co-operation is required when a carer has to perform oral hygiene
        measures and access to the mouth has to be granted. Poor oral hygiene and the presence of
        abundant biofilm fosters periodontal disease and caries. Combined with a shift in dietary
        intake towards more sweet food-stuffs the risk factors for developing carious lesions
        increases significantly. The risk of caries is further increased as result of a decreased
        salivary flow due to medication intake.
  
        Previous research has demonstrated that the use of a powered toothbrush instead of a manual
        one reduces plaque and gingivitis more effectively than manual toothbrushes . The reduction
        of gingivitis using an electric toothbrush as compared to a manual one is reported to be in
        the range of 11 to 17%. According to the American Dental association tooth brushing should be
        performed twice daily for two minutes each time. On average it is estimated that people brush
        their teeth for less than a minute per day. The efficacy of a toothbrush is highly dependent
        on how long time the individual is actually using the device and it can be anticipated that
        individuals with mild cognitive impairment may forget to use the tooth brush on a daily basis
        and also that whenever using the brush the time spent may be even shorter than 30 seconds
        each time. The control group will be supplied with a powered toothbrush only and instructed
        to use any other means of tooth cleaning (ie. interdental cleaning) as before. It is
        anticipated that a temporary improvement of oral hygiene will occur in the control group, but
        the temporary improvement may not be sustainable among individuals with mild cognitive
        impairment. Accordingly, there will not be an added benefit for either the individual or the
        society only to supply individuals with cognitive impairment with a powered toothbrush.
  
        In the test group, individuals are supplied with a powered toothbrush and a tablet with
        reminder functions. It is anticipated that the brush will be used more frequently and
        possibly also for longer periods compared to the group without such reminder functions,
        resulting in >30% improvement compared to the control group.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: RCT
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Change in the amount of dental plaque
  time frame: From baseline, to month 6, and to month 12, and to month 24, and to month 36
  description: Presence of dental plaque measured on four of the tooth surfaces presented as a percentage
  measure: Change in the amount of gingival bleeding on probing
  time frame: From baseline, to month 6, and to month 12, and to month 24, and to month 36
  description: Number of bleeding from the gingiva measured on four sides of the teeth presented as a percentage
  measure: Change in the number of periodontal pockets 4 mm or deeper
  time frame: From baseline, to month 6, and to month 12, and to month 24, and to month 36
  description: The number of periodontal pockets 4 mm or deeper measured on four of the tooth surfaces presented as a percentage
  measure: Change in values for the quality of life instrument QoL-AD
  time frame: From baseline, to month 6, and to month 12, and to month 24, and to month 36
  description: The value for the quality of life instrument QoL-AD (Quality of Life Alzheimer Disease) is measured on a scale from 0-30, where 30 corresponds to the highest quality of life
  measure: Change in values for the oral health related quality of life instrument OHIP-14
  time frame: From baseline, to month 6, and to month 12, and to month 24, and to month 36
  description: The value for the oral health-related quality of life instrument OHIP-14 (Oral Health Impact Profile-14) is measured on a scale from 0-56 where 0 corresponds to the highest quality of life
  arm group label: Intervention
  arm group type: Experimental
  description: Reminder function
  arm group label: control
  arm group type: No Intervention
  description: No reminder
  intervention type: Device
  intervention name: Reminder function on Android computer tablet
  description: Computer tablet with reminder function
  arm group label: Intervention
  criteria: 
  gender: All
  minimum age: 55 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Johan Sanmartin-Berglund, Professor
  role: Study Chair
  affiliation: Blekinge Institute of Technology
  facility: 
  country: Sweden
  responsible party type: Sponsor
  mesh term: Gingivitis
  mesh term: Periodontal Diseases
  mesh term: Cognitive Dysfunction
  sharing ipd: Yes
  ipd description: The trial protocol and the datasets used and analyzed during the current study are available upon reasonable request.
  ipd info type: Study Protocol
  ipd time frame: From 2023-06-12
  ipd access criteria: The trial protocol and the datasets used and analyzed during the current study are available upon reasonable request.