The Second People's Hospital of Hefei, Hefei Hospital Affiliated to Anhui Medical University, 246 Heping Road, Hefei, China.
Department of Dental Public Health, Faculty of Dentistry, The University of Hong Kong, 34 Hospital Road, Sai Ying Pun, Hong Kong.
Trials. 2020 Jul 10;21(1):634. doi: 10.1186/s13063-020-04528-3.
The prevalence of pneumonia complicating stroke in acute phase has a poor prognosis and higher risk for death. Oral opportunistic pathogens have been reported to be associated with pneumonia among people with compromised health. Oral health promotion is effective in reducing dental plaque among patients with stroke, which is considered as reservoirs for oral opportunistic pathogens. This study evaluates the effectiveness of oral health promotions in reducing the prevalence of pneumonia via its effects on composition and relative abundance of oral opportunistic pathogens.
METHODS/DESIGN: This study is a randomized, single-blind, parallel trial of 6 months duration. The study is being conducted at one of the largest medical teaching hospitals in Hefei, China. A total of 166 patients with stroke and free from any post-stroke complication will be recruited. After enrollment, patients will be randomized to one of the following groups: (1) oral hygiene instruction (OHI) or (2) OHI, 6-month use of powered tooth brushing, and 0.2% chlorhexidine gluconate mouth rinse (10 ml twice daily). The primary outcome is the prevalence of pneumonia complicating stroke. Patients will be monitored closely for any occurrence of pneumonia over the entire period of this trial. Oral rinse samples will be collected at baseline and multiple follow-up reviews (3, 5, 7 days, and 1, 3, 6 months after baseline). Next-generation sequencing will be employed to detect composition and relative abundances of the microorganism in the oral rinse samples. Questionnaire interviews and clinical oral examinations will be conducted at baseline and 1, 3, and 6 months after baseline.
The findings of this trial will provide evidence whether oral health promotion intervention is effective in reducing the prevalence of pneumonia complicating stroke via its effect on the oral microbiome. The analysis of the outcomes of this trial is empowered by metagenomic analysis at 16S rRNA level, which is more sensitive and comprehensive to help us detect how oral health promotion inventions affect the oral microbiome in terms of its composition, relative abundance, and interactions between species, which all may contribute to the occurrence of pneumonia complicating stroke.
ClinicalTrials.gov NCT04095780 . Registered on 19 September 2019.
卒中急性期并发肺炎的患病率预后较差，死亡风险较高。有报道称，口腔机会致病菌与健康受损人群的肺炎有关。口腔健康促进可有效减少卒中患者的牙菌斑，而牙菌斑被认为是口腔机会致病菌的储存库。本研究通过评估口腔机会致病菌的组成和相对丰度，评估口腔健康促进对降低肺炎患病率的效果。
方法/设计：这是一项为期 6 个月的随机、单盲、平行试验。该研究在合肥市最大的一家医学教学医院进行。共招募 166 例无卒中后并发症的卒中患者。入组后，患者将随机分为以下两组：（1）口腔卫生指导（OHI）或（2）OHI、6 个月使用电动牙刷和 0.2%葡萄糖酸氯己定漱口液（10ml，每日 2 次）。主要结局是卒中并发肺炎的患病率。整个试验期间，将密切监测患者是否发生肺炎。在基线和多次随访（基线后 3、5、7 天和 1、3、6 个月）时采集漱口水样本。采用下一代测序技术检测漱口水样本中微生物的组成和相对丰度。基线和基线后 1、3 和 6 个月时进行问卷调查和临床口腔检查。
该试验的结果将提供证据，证明口腔健康促进干预是否通过影响口腔微生物组降低卒中并发肺炎的患病率。本试验结果的分析得益于 16S rRNA 水平的宏基因组分析，该分析更敏感、更全面，可以帮助我们检测口腔健康促进发明如何在组成、相对丰度和种间相互作用方面影响口腔微生物组，所有这些都可能导致卒中并发肺炎的发生。
ClinicalTrials.gov NCT04095780。于 2019 年 9 月 19 日注册。
