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临床试验/NCT03874962
NCT03874962已完成不适用

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

Kaohsiung Medical University Chung-Ho Memorial Hospital0 个研究点目标入组 220 人开始时间: 2015年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
220
主要终点
Pneumonia hospitalization status

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
51 Years 至 102 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Informed consent
  • 51 year-old and above
  • Being bedridden for ≥ 6 months
  • Positive sputum production
  • Difficulty in swallowing reported by caregivers

排除标准

  • Below 51 year-old
  • Patients or family refused any oral care

研究组 & 干预措施

Routine oral cleaning and professional oral care group

Experimental

The subjects in "Routine oral cleaning and professional oral care group" were received about routine oral cleaning and professional oral care.

干预措施: Routine oral cleaning and professional oral care group (Other)

Routine oral cleaning group

No Intervention

The subjects in "Routine oral cleaning group" were received only routine oral cleaning, just maintain daily condition.

结局指标

主要结局

Pneumonia hospitalization status

时间窗: 2 hours

Hospitalization prevalence and days of each hospitalization due to pneumonia were collected from medical records by questionnaire.

Bacterial concentrations

时间窗: 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).

次要结局

  • Oral health examinations(3 hours)
  • Demographic data(1 hour)

研究者

申办方类型
Other
责任方
Sponsor

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