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Improvements in Pneumonia Status After Oral Care Intervention in Taiwan

Primary Purpose

Pneumonia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Routine oral cleaning and professional oral care group
Sponsored by
Kaohsiung Medical University Chung-Ho Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pneumonia focused on measuring Oral care intervention, Nursing home residents

Eligibility Criteria

51 Years - 102 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Informed consent
  • 51 year-old and above
  • Being bedridden for ≥ 6 months
  • Positive sputum production
  • Difficulty in swallowing reported by caregivers

Exclusion Criteria:

  • Below 51 year-old
  • Patients or family refused any oral care

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Routine oral cleaning and professional oral care group

    Routine oral cleaning group

    Arm Description

    The subjects in "Routine oral cleaning and professional oral care group" were received about routine oral cleaning and professional oral care.

    The subjects in "Routine oral cleaning group" were received only routine oral cleaning, just maintain daily condition.

    Outcomes

    Primary Outcome Measures

    Pneumonia hospitalization status
    Hospitalization prevalence and days of each hospitalization due to pneumonia were collected from medical records by questionnaire.
    Bacterial concentrations
    Total salivary and sputum bacterial concentrations were determined using real-time polymerase chain reaction. Staphylococcus aureus (strain ID: ATCC 29213) was used to create the standard growth curve of bacteria. After overnight culture, the samples were prepared by 5-fold serial dilution with normal saline and plating in a Petri dish to produce 2.5×103 to 3.9×107 CFU/mL of bacteria. Genomic DNA of bacteria was extracted from 1 mL of each bacterial serial solution using the modified standard method, which followed three basic steps: lysis, precipitation, and purification. The DNA extracts were resuspended in 20 µL of distilled water and stored at -80°C until real-time polymerase chain reaction (RT-PCR) amplification. The standard curve of bacterial concentration was generated by the bacterial 16S rRNA gene using a serial dilution of Staphylococcus aureus genomic DNA and StepOnePlus Real-Time PCR System (Applied Biosystems).

    Secondary Outcome Measures

    Oral health examinations
    Oral health examinations were conducted by two trained dentists, and data on plaque, gingival, and tongue coating indexes were collected by oral examination tables.
    Demographic data
    Demographic data included gender, age groups, conscious, educational level, and nutritional route, which were collected by questionnaire.

    Full Information

    First Posted
    April 18, 2018
    Last Updated
    March 12, 2019
    Sponsor
    Kaohsiung Medical University Chung-Ho Memorial Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03874962
    Brief Title
    Improvements in Pneumonia Status After Oral Care Intervention in Taiwan
    Official Title
    Improvements in Pneumonia Status and Salivary Bacterial Concentration After Professional Oral Care Intervention in Taiwanese Nursing Home Residents
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    August 1, 2015 (Actual)
    Primary Completion Date
    September 1, 2015 (Actual)
    Study Completion Date
    September 30, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Kaohsiung Medical University Chung-Ho Memorial Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The correlation between improvement in oral health, reduction in oral bacterial concentration, and status of pneumonia hospitalization remains unclear. To determine the effects of professional oral care intervention on the index of oral health, salivary and sputum bacterial concentrations, and pneumonia hospitalization status of nursing home residents using a quasi-experimental study. Two nursing homes were on demand selected as the intervention and control groups; in the intervention group, weekly professional oral care was administered in addition to regular oral care by trained dental hygienists. Demographic data and oral health status were analyzed. Total salivary and sputum bacterial concentrations were determined using real-time polymerase chain reaction.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pneumonia
    Keywords
    Oral care intervention, Nursing home residents

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Non-Randomized
    Enrollment
    220 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Routine oral cleaning and professional oral care group
    Arm Type
    Experimental
    Arm Description
    The subjects in "Routine oral cleaning and professional oral care group" were received about routine oral cleaning and professional oral care.
    Arm Title
    Routine oral cleaning group
    Arm Type
    No Intervention
    Arm Description
    The subjects in "Routine oral cleaning group" were received only routine oral cleaning, just maintain daily condition.
    Intervention Type
    Other
    Intervention Name(s)
    Routine oral cleaning and professional oral care group
    Intervention Description
    Besides routine oral cleaning was conducted by caregivers, professional oral care intervention was conducted by dental hygienists, and it included muscle massage, oral cleaning, and oral health education once a week.
    Primary Outcome Measure Information:
    Title
    Pneumonia hospitalization status
    Description
    Hospitalization prevalence and days of each hospitalization due to pneumonia were collected from medical records by questionnaire.
    Time Frame
    2 hours
    Title
    Bacterial concentrations
    Description
    Total salivary and sputum bacterial concentrations were determined using real-time polymerase chain reaction. Staphylococcus aureus (strain ID: ATCC 29213) was used to create the standard growth curve of bacteria. After overnight culture, the samples were prepared by 5-fold serial dilution with normal saline and plating in a Petri dish to produce 2.5×103 to 3.9×107 CFU/mL of bacteria. Genomic DNA of bacteria was extracted from 1 mL of each bacterial serial solution using the modified standard method, which followed three basic steps: lysis, precipitation, and purification. The DNA extracts were resuspended in 20 µL of distilled water and stored at -80°C until real-time polymerase chain reaction (RT-PCR) amplification. The standard curve of bacterial concentration was generated by the bacterial 16S rRNA gene using a serial dilution of Staphylococcus aureus genomic DNA and StepOnePlus Real-Time PCR System (Applied Biosystems).
    Time Frame
    3 hours
    Secondary Outcome Measure Information:
    Title
    Oral health examinations
    Description
    Oral health examinations were conducted by two trained dentists, and data on plaque, gingival, and tongue coating indexes were collected by oral examination tables.
    Time Frame
    3 hours
    Title
    Demographic data
    Description
    Demographic data included gender, age groups, conscious, educational level, and nutritional route, which were collected by questionnaire.
    Time Frame
    1 hour

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    51 Years
    Maximum Age & Unit of Time
    102 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Informed consent 51 year-old and above Being bedridden for ≥ 6 months Positive sputum production Difficulty in swallowing reported by caregivers Exclusion Criteria: Below 51 year-old Patients or family refused any oral care
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Shun-Te Huang, Professor
    Organizational Affiliation
    Kaohsiung Medical University Chung-Ho Memorial Hospital
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    De-identified IPD for outcome measures will be made available.
    IPD Sharing Time Frame
    starting 6 months after publication
    Citations:
    PubMed Identifier
    36383760
    Citation
    Cao Y, Liu C, Lin J, Ng L, Needleman I, Walsh T, Li C. Oral care measures for preventing nursing home-acquired pneumonia. Cochrane Database Syst Rev. 2022 Nov 16;11(11):CD012416. doi: 10.1002/14651858.CD012416.pub3.
    Results Reference
    derived
    PubMed Identifier
    32460697
    Citation
    Chiang TC, Huang MS, Lu PL, Huang ST, Lin YC. The effect of oral care intervention on pneumonia hospitalization, Staphylococcus aureus distribution, and salivary bacterial concentration in Taiwan nursing home residents: a pilot study. BMC Infect Dis. 2020 May 27;20(1):374. doi: 10.1186/s12879-020-05061-z.
    Results Reference
    derived

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    Improvements in Pneumonia Status After Oral Care Intervention in Taiwan

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