Improvements in Pneumonia Status After Oral Care Intervention in Taiwan

Overview

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.

Full Title of Study: “Improvements in Pneumonia Status and Salivary Bacterial Concentration After Professional Oral Care Intervention in Taiwanese Nursing Home Residents”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Triple (Participant, Care Provider, Outcomes Assessor)
  • Study Primary Completion Date: September 1, 2015

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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.
  • No Intervention: Routine oral cleaning group
    • The subjects in “Routine oral cleaning group” were received only routine oral cleaning, just maintain daily condition.

Clinical Trial Outcome Measures

Primary Measures

  • 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).

Secondary Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 51 Years

Maximum Age: 102 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Shun-Te Huang, Professor, Study Chair, Kaohsiung Medical University Chung-Ho Memorial Hospital

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