Improvements in Pneumonia Status After Oral Care Intervention in Taiwan
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|ClinicalTrials.gov Identifier: NCT03874962|
Recruitment Status : Completed
First Posted : March 14, 2019
Last Update Posted : March 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pneumonia||Other: Routine oral cleaning and professional oral care group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||220 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Improvements in Pneumonia Status and Salivary Bacterial Concentration After Professional Oral Care Intervention in Taiwanese Nursing Home Residents|
|Actual Study Start Date :||August 1, 2015|
|Actual Primary Completion Date :||September 1, 2015|
|Actual Study Completion Date :||September 30, 2017|
Experimental: Routine oral cleaning and professional oral care group
The subjects in "Routine oral cleaning and professional oral care group" were received about routine oral cleaning and professional oral care.
Other: Routine oral cleaning and professional oral care group
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.
No Intervention: Routine oral cleaning group
The subjects in "Routine oral cleaning group" were received only routine oral cleaning, just maintain daily condition.
- Pneumonia hospitalization status [ Time Frame: 2 hours ]Hospitalization prevalence and days of each hospitalization due to pneumonia were collected from medical records by questionnaire.
- Bacterial concentrations [ Time Frame: 3 hours ]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).
- Oral health examinations [ Time Frame: 3 hours ]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 [ Time Frame: 1 hour ]Demographic data included gender, age groups, conscious, educational level, and nutritional route, which were collected by questionnaire.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03874962
|Study Chair:||Shun-Te Huang, Professor||Kaohsiung Medical University Chung-Ho Memorial Hospital|