Improvements in Pneumonia Status After Oral Care Intervention in Taiwan

Pneumonia Clinical Trial

Official title:

Improvements in Pneumonia Status and Salivary Bacterial Concentration After Professional Oral Care Intervention in Taiwanese Nursing Home Residents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03874962
• Other study ID #: KMUH103-3M47
• Status: Completed
• Phase: N/A
• Start date: August 1, 2015
• Est. completion date: September 30, 2017

Study information

• Verified date: March 2019
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: September 30, 2017
• Est. primary completion date: September 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 51 Years to 102 Years

Eligibility

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

Related Conditions & MeSH terms

• Pneumonia

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pneumonia hospitalization status	Hospitalization prevalence and days of each hospitalization due to pneumonia were collected from medical records by questionnaire.	2 hours
Primary	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).	3 hours
Secondary	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.	3 hours
Secondary	Demographic data	Demographic data included gender, age groups, conscious, educational level, and nutritional route, which were collected by questionnaire.	1 hour