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
About this trial
This is an interventional supportive care trial for Pneumonia focused on measuring Oral care intervention, Nursing home residents
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
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
NCT ID
NCT03874962
First Posted
April 18, 2018
Last Updated
March 12, 2019
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
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
Learn more about this trial
Improvements in Pneumonia Status After Oral Care Intervention in Taiwan
We'll reach out to this number within 24 hrs