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/NCT05987982</url>
    </required_header>
    <id_info>
      <org_study_id>B-ER-111-452</org_study_id>
      <nct_id>NCT05987982</nct_id>
    </id_info>
    <brief_title>Mouth Odor on Preventing Pneumonia by Oral Frailty</brief_title>
    <official_title>Mouth Odor as a Precision Care Indicator for Preventing Pneumonia Among Middle-aged and Older Adults With Oral Frailty</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>National Cheng-Kung University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>National Cheng-Kung University Hospital</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>
        This research plan aims to first collect data on the oral function and oral hygiene status of&#xD;
        the elderly population in the community and to understand the normal model of oral frailty&#xD;
        among the older adults in the community. Subsequently, a comparison will be made between the&#xD;
        oral status of hospitalized patients and the community-dwelling elderly population. The goal&#xD;
        is to verify whether oral odor can be used as an objective biological indicator following&#xD;
        intervention.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The first stage will aim to examine the relationships between the level of oral frailty and&#xD;
        pneumonia-associated pathogens, as well as to establish a mouth odor database among&#xD;
        community-dwelling people; The second stage will compare the differences of the level of oral&#xD;
        frailty, pneumonia associated pathogens, and mouth odor between 144 middle-aged and older&#xD;
        healthy people and 160 hospitalization patients. The third stage will confirm whether the&#xD;
        mouth odor is an effective biological maker to show the changes of oral frailty,&#xD;
        pneumonia-associated pathogens, and mouth odor after oral management rehabilitation.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 14, 2023</start_date>
    <completion_date type="Anticipated">July 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2026</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>Oral management group: oral exercises and oral care.&#xD;
  Oral care group: oral hygiene.&#xD;
  Routine group</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Clearance of pneumonia associated oral bacteria</measure>
      <time_frame>The first day of admission (baseline)</time_frame>
      <description>The investigators collected tongue specimens from participants for bacterial isolation and identification. The participants' specimens were collected using an eswab and sent for bacterial culture within 2 hours. Bacterial colonies were quantified (CFU/ml). To observe the variation caused by the number of bacteria, measurements were taken again after the intervention. The investigators assessed the clearance of bacteria based on the baseline.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Clearance of pneumonia associated oral bacteria</measure>
      <time_frame>Day 3 of admission</time_frame>
      <description>The investigators collected tongue specimens from participants for bacterial isolation and identification. The participants' specimens were collected using an eswab and sent for bacterial culture within 2 hours. Bacterial colonies were quantified (CFU/ml). To observe the variation caused by the number of bacteria, measurements were taken again after the intervention. The investigators assessed the clearance of bacteria based on the baseline.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Clearance of pneumonia associated oral bacteria</measure>
      <time_frame>Discharge day</time_frame>
      <description>The investigators collected tongue specimens from participants for bacterial isolation and identification. The participants' specimens were collected using an eswab and sent for bacterial culture within 2 hours. Bacterial colonies were quantified (CFU/ml). To observe the variation caused by the number of bacteria, measurements were taken again after the intervention. The investigators assessed the clearance of bacteria based on the baseline.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Clearance of pneumonia associated oral bacteria</measure>
      <time_frame>1-week after discharge day</time_frame>
      <description>The investigators collected tongue specimens from participants for bacterial isolation and identification. The participants' specimens were collected using an eswab and sent for bacterial culture within 2 hours. Bacterial colonies were quantified (CFU/ml). To observe the variation caused by the number of bacteria, measurements were taken again after the intervention. The investigators assessed the clearance of bacteria based on the baseline.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Clearance of pneumonia associated oral bacteria</measure>
      <time_frame>1-month after discharge day</time_frame>
      <description>The investigators collected tongue specimens from participants for bacterial isolation and identification. The participants' specimens were collected using an eswab and sent for bacterial culture within 2 hours. Bacterial colonies were quantified (CFU/ml). To observe the variation caused by the number of bacteria, measurements were taken again after the intervention. The investigators assessed the clearance of bacteria based on the baseline.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>oral frailty measures (oral functions)</measure>
      <time_frame>The first day of admission (baseline)</time_frame>
      <description>The investigators measured seven items for patients to identify oral frailty including 1) the number of teeth, 2) masticatory ability, 3) difficulty making the &quot;ta&quot; sound, 4) tongue pressure, 5) abnormal swallowing pressure, and 6) tongue coating index (TCI), 7) oral dryness. Oral frailty was determined into three groups: non-oral frailty, 0 points; pre-oral frailty, 1-2 points; and oral frailty, ≥ 3 points.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>oral frailty measures (oral functions)</measure>
      <time_frame>Day 3 of admission</time_frame>
      <description>The investigators measured seven items for patients to identify oral frailty including 1) the number of teeth, 2) masticatory ability, 3) difficulty making the &quot;ta&quot; sound, 4) tongue pressure, 5) abnormal swallowing pressure, and 6) tongue coating index (TCI), 7) oral dryness. Oral frailty was determined into three groups: non-oral frailty, 0 points; pre-oral frailty, 1-2 points; and oral frailty, ≥ 3 points.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>oral frailty measures (oral functions)</measure>
      <time_frame>Discharge day</time_frame>
      <description>The investigators measured seven items for patients to identify oral frailty including 1) the number of teeth, 2) masticatory ability, 3) difficulty making the &quot;ta&quot; sound, 4) tongue pressure, 5) abnormal swallowing pressure, and 6) tongue coating index (TCI), 7) oral dryness. Oral frailty was determined into three groups: non-oral frailty, 0 points; pre-oral frailty, 1-2 points; and oral frailty, ≥ 3 points.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>oral frailty measures (oral functions)</measure>
      <time_frame>1-week after discharge day</time_frame>
      <description>The investigators measured seven items for patients to identify oral frailty including 1) the number of teeth, 2) masticatory ability, 3) difficulty making the &quot;ta&quot; sound, 4) tongue pressure, 5) abnormal swallowing pressure, and 6) tongue coating index (TCI), 7) oral dryness. Oral frailty was determined into three groups: non-oral frailty, 0 points; pre-oral frailty, 1-2 points; and oral frailty, ≥ 3 points.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>oral frailty measures (oral functions)</measure>
      <time_frame>1-month after discharge day</time_frame>
      <description>The investigators measured seven items for patients to identify oral frailty including 1) the number of teeth, 2) masticatory ability, 3) difficulty making the &quot;ta&quot; sound, 4) tongue pressure, 5) abnormal swallowing pressure, and 6) tongue coating index (TCI), 7) oral dryness. Oral frailty was determined into three groups: non-oral frailty, 0 points; pre-oral frailty, 1-2 points; and oral frailty, ≥ 3 points.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Oral odor</measure>
      <time_frame>The first day of admission (baseline)</time_frame>
      <description>A participant was requested to exhale two gas sampling gas for testing. The investigators uesd an E-nose to identify the participants' odor. To assess the variation of oral odor after different interventions.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Oral odor</measure>
      <time_frame>Day 3 of admission</time_frame>
      <description>A participant was requested to exhale two gas sampling gas for testing. The investigators uesd an E-nose to identify the participants' odor. To assess the variation of oral odor after different interventions.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Oral odor</measure>
      <time_frame>Discharge day</time_frame>
      <description>A participant was requested to exhale two gas sampling gas for testing. The investigators uesd an E-nose to identify the participants' odor. To assess the variation of oral odor after different interventions.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Oral odor</measure>
      <time_frame>1-week after discharge day</time_frame>
      <description>A participant was requested to exhale two gas sampling gas for testing. The investigators uesd an E-nose to identify the participants' odor. To assess the variation of oral odor after different interventions.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Oral odor</measure>
      <time_frame>1-month after discharge day</time_frame>
      <description>A participant was requested to exhale two gas sampling gas for testing. The investigators uesd an E-nose to identify the participants' odor. To assess the variation of oral odor after different interventions.</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">304</enrollment>
    <condition>Breathing, Mouth</condition>
    <condition>Pneumonia</condition>
    <condition>Frailty</condition>
    <arm_group>
      <arm_group_label>Group with oral management</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The investigators taught and monitored patients or caregivers to oral health care plus oral exercises such as salivary glands massage methods after meals and before sleep.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group with oral care</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The investigators taught and monitored patients or caregivers to do oral care after meals and before sleep.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group with standard of care</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Only provided oral care education.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Oral exercises and oral hygiene</intervention_name>
      <description>The patients will be required to perform oral exercises and maintain oral hygiene twice a day. The investigators will assess their oral frailty, oral bacteria, oral odor, and other related clinical care data on the following time points: day 1 of hospitalization, day 3 of hospitalization, the day of discharge, one week after discharge, and one month after discharge.</description>
      <arm_group_label>Group with oral management</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Oral care</intervention_name>
      <description>The patients will be required to maintain oral hygiene twice a day. The investigators will assess their oral frailty, oral bacteria, oral odor, and other related clinical care data on the following time points: day 1 of hospitalization, day 3 of hospitalization, the day of discharge, one week after discharge, and one month after discharge.</description>
      <arm_group_label>Group with oral care</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥ 50 years old,&#xD;
  &#xD;
            -  Alert and oriented,&#xD;
  &#xD;
            -  With sufficient comprehension and cooperation,&#xD;
  &#xD;
            -  Willing to participate in oral assessment.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who score below 5 on the General Practitioner Assessment of Cognition&#xD;
               (GPCOG),&#xD;
  &#xD;
            -  Patients with oral treatments such as oral cancer treatment,&#xD;
  &#xD;
            -  Patients with oral treatments such as periodontal disease treatment.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Yen-Chin Chen</last_name>
      <phone>+886-6-2353535</phone>
      <phone_ext>2019</phone_ext>
      <email>yenchin2427@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University</name>
        <address>
          <city>Tainan City</city>
          <zip>704</zip>
          <country>Taiwan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>YenChin Chen</last_name>
        <phone>+886-6-2353535</phone>
        <phone_ext>2019</phone_ext>
        <email>yenchin2427@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 13, 2023</last_update_submitted>
    <last_update_submitted_qc>August 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>National Cheng-Kung University Hospital</investigator_affiliation>
      <investigator_full_name>Chen, Yen-Chin</investigator_full_name>
      <investigator_title>Vice Head Nurse and Clinical Assistant Professor</investigator_title>
    </responsible_party>
    <keyword>mouth odor</keyword>
    <keyword>pneumonia</keyword>
    <keyword>oral bacteria</keyword>
    <keyword>oral frailty</keyword>
    <keyword>oral management rehabilitation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pneumonia</mesh_term>
      <mesh_term>Mouth Breathing</mesh_term>
      <mesh_term>Frailty</mesh_term>
    </condition_browse>
    <!-- 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/NCT05987982
  org study id: B-ER-111-452
  nct id: NCT05987982
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This research plan aims to first collect data on the oral function and oral hygiene status of
        the elderly population in the community and to understand the normal model of oral frailty
        among the older adults in the community. Subsequently, a comparison will be made between the
        oral status of hospitalized patients and the community-dwelling elderly population. The goal
        is to verify whether oral odor can be used as an objective biological indicator following
        intervention.
  The first stage will aim to examine the relationships between the level of oral frailty and
        pneumonia-associated pathogens, as well as to establish a mouth odor database among
        community-dwelling people; The second stage will compare the differences of the level of oral
        frailty, pneumonia associated pathogens, and mouth odor between 144 middle-aged and older
        healthy people and 160 hospitalization patients. The third stage will confirm whether the
        mouth odor is an effective biological maker to show the changes of oral frailty,
        pneumonia-associated pathogens, and mouth odor after oral management rehabilitation.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Oral management group: oral exercises and oral care.
  Oral care group: oral hygiene.
  Routine group
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Clearance of pneumonia associated oral bacteria
  time frame: The first day of admission (baseline)
  description: The investigators collected tongue specimens from participants for bacterial isolation and identification. The participants' specimens were collected using an eswab and sent for bacterial culture within 2 hours. Bacterial colonies were quantified (CFU/ml). To observe the variation caused by the number of bacteria, measurements were taken again after the intervention. The investigators assessed the clearance of bacteria based on the baseline.
  measure: Clearance of pneumonia associated oral bacteria
  time frame: Day 3 of admission
  description: The investigators collected tongue specimens from participants for bacterial isolation and identification. The participants' specimens were collected using an eswab and sent for bacterial culture within 2 hours. Bacterial colonies were quantified (CFU/ml). To observe the variation caused by the number of bacteria, measurements were taken again after the intervention. The investigators assessed the clearance of bacteria based on the baseline.
  measure: Clearance of pneumonia associated oral bacteria
  time frame: Discharge day
  description: The investigators collected tongue specimens from participants for bacterial isolation and identification. The participants' specimens were collected using an eswab and sent for bacterial culture within 2 hours. Bacterial colonies were quantified (CFU/ml). To observe the variation caused by the number of bacteria, measurements were taken again after the intervention. The investigators assessed the clearance of bacteria based on the baseline.
  measure: Clearance of pneumonia associated oral bacteria
  time frame: 1-week after discharge day
  description: The investigators collected tongue specimens from participants for bacterial isolation and identification. The participants' specimens were collected using an eswab and sent for bacterial culture within 2 hours. Bacterial colonies were quantified (CFU/ml). To observe the variation caused by the number of bacteria, measurements were taken again after the intervention. The investigators assessed the clearance of bacteria based on the baseline.
  measure: Clearance of pneumonia associated oral bacteria
  time frame: 1-month after discharge day
  description: The investigators collected tongue specimens from participants for bacterial isolation and identification. The participants' specimens were collected using an eswab and sent for bacterial culture within 2 hours. Bacterial colonies were quantified (CFU/ml). To observe the variation caused by the number of bacteria, measurements were taken again after the intervention. The investigators assessed the clearance of bacteria based on the baseline.
  measure: oral frailty measures (oral functions)
  time frame: The first day of admission (baseline)
  description: The investigators measured seven items for patients to identify oral frailty including 1) the number of teeth, 2) masticatory ability, 3) difficulty making the "ta" sound, 4) tongue pressure, 5) abnormal swallowing pressure, and 6) tongue coating index (TCI), 7) oral dryness. Oral frailty was determined into three groups: non-oral frailty, 0 points; pre-oral frailty, 1-2 points; and oral frailty, ≥ 3 points.
  measure: oral frailty measures (oral functions)
  time frame: Day 3 of admission
  description: The investigators measured seven items for patients to identify oral frailty including 1) the number of teeth, 2) masticatory ability, 3) difficulty making the "ta" sound, 4) tongue pressure, 5) abnormal swallowing pressure, and 6) tongue coating index (TCI), 7) oral dryness. Oral frailty was determined into three groups: non-oral frailty, 0 points; pre-oral frailty, 1-2 points; and oral frailty, ≥ 3 points.
  measure: oral frailty measures (oral functions)
  time frame: Discharge day
  description: The investigators measured seven items for patients to identify oral frailty including 1) the number of teeth, 2) masticatory ability, 3) difficulty making the "ta" sound, 4) tongue pressure, 5) abnormal swallowing pressure, and 6) tongue coating index (TCI), 7) oral dryness. Oral frailty was determined into three groups: non-oral frailty, 0 points; pre-oral frailty, 1-2 points; and oral frailty, ≥ 3 points.
  measure: oral frailty measures (oral functions)
  time frame: 1-week after discharge day
  description: The investigators measured seven items for patients to identify oral frailty including 1) the number of teeth, 2) masticatory ability, 3) difficulty making the "ta" sound, 4) tongue pressure, 5) abnormal swallowing pressure, and 6) tongue coating index (TCI), 7) oral dryness. Oral frailty was determined into three groups: non-oral frailty, 0 points; pre-oral frailty, 1-2 points; and oral frailty, ≥ 3 points.
  measure: oral frailty measures (oral functions)
  time frame: 1-month after discharge day
  description: The investigators measured seven items for patients to identify oral frailty including 1) the number of teeth, 2) masticatory ability, 3) difficulty making the "ta" sound, 4) tongue pressure, 5) abnormal swallowing pressure, and 6) tongue coating index (TCI), 7) oral dryness. Oral frailty was determined into three groups: non-oral frailty, 0 points; pre-oral frailty, 1-2 points; and oral frailty, ≥ 3 points.
  measure: Oral odor
  time frame: The first day of admission (baseline)
  description: A participant was requested to exhale two gas sampling gas for testing. The investigators uesd an E-nose to identify the participants' odor. To assess the variation of oral odor after different interventions.
  measure: Oral odor
  time frame: Day 3 of admission
  description: A participant was requested to exhale two gas sampling gas for testing. The investigators uesd an E-nose to identify the participants' odor. To assess the variation of oral odor after different interventions.
  measure: Oral odor
  time frame: Discharge day
  description: A participant was requested to exhale two gas sampling gas for testing. The investigators uesd an E-nose to identify the participants' odor. To assess the variation of oral odor after different interventions.
  measure: Oral odor
  time frame: 1-week after discharge day
  description: A participant was requested to exhale two gas sampling gas for testing. The investigators uesd an E-nose to identify the participants' odor. To assess the variation of oral odor after different interventions.
  measure: Oral odor
  time frame: 1-month after discharge day
  description: A participant was requested to exhale two gas sampling gas for testing. The investigators uesd an E-nose to identify the participants' odor. To assess the variation of oral odor after different interventions.
  arm group label: Group with oral management
  arm group type: Experimental
  description: The investigators taught and monitored patients or caregivers to oral health care plus oral exercises such as salivary glands massage methods after meals and before sleep.
  arm group label: Group with oral care
  arm group type: Experimental
  description: The investigators taught and monitored patients or caregivers to do oral care after meals and before sleep.
  arm group label: Group with standard of care
  arm group type: No Intervention
  description: Only provided oral care education.
  intervention type: Procedure
  intervention name: Oral exercises and oral hygiene
  description: The patients will be required to perform oral exercises and maintain oral hygiene twice a day. The investigators will assess their oral frailty, oral bacteria, oral odor, and other related clinical care data on the following time points: day 1 of hospitalization, day 3 of hospitalization, the day of discharge, one week after discharge, and one month after discharge.
  arm group label: Group with oral management
  intervention type: Procedure
  intervention name: Oral care
  description: The patients will be required to maintain oral hygiene twice a day. The investigators will assess their oral frailty, oral bacteria, oral odor, and other related clinical care data on the following time points: day 1 of hospitalization, day 3 of hospitalization, the day of discharge, one week after discharge, and one month after discharge.
  arm group label: Group with oral care
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Yen-Chin Chen
  phone: +886-6-2353535
  phone ext: 2019
  email: yenchin2427@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Taiwan
  responsible party type: Principal Investigator
  investigator affiliation: National Cheng-Kung University Hospital
  investigator full name: Chen, Yen-Chin
  investigator title: Vice Head Nurse and Clinical Assistant Professor
  mesh term: Pneumonia
  mesh term: Mouth Breathing
  mesh term: Frailty