Improvements in Pneumonia Status After Oral Care Intervention in Taiwan

Not Applicable

Completed

• Conditions: Pneumonia
• Interventions: Other: Routine oral cleaning and professional oral care group

• Registration Number: NCT03874962
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08-01
• Primary Completion: 2015-09-01
• Study Completion: 2017-09-30
• Study First Submitted: 2018-04-18
• Status Verified: 2019-03
• Study First Submitted QC: 2019-03-12
• Last Update Submitted: 2019-03-12
• Study First Posted: 2019-03-14
• Last Update Posted: 2019-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Routine oral cleaning and professional oral care group	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.

Primary Outcome Measures

Name	Time	Method
Pneumonia hospitalization status	2 hours	Hospitalization prevalence and days of each hospitalization due to pneumonia were collected from medical records by questionnaire.
Bacterial concentrations	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).

Secondary Outcome Measures

Name	Time	Method
Oral health examinations	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	1 hour	Demographic data included gender, age groups, conscious, educational level, and nutritional route, which were collected by questionnaire.