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Using metagenomic analysis to assess the effectiveness of oral health promotion interventions in reducing risk for pneumonia among patients with stroke in acute phase: study protocol for a randomized controlled trial.
Trials. 2020 Jul 10; 21(1):634.T

Abstract

BACKGROUND

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.

DISCUSSION

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.

TRIAL REGISTRATION

ClinicalTrials.gov NCT04095780 . Registered on 19 September 2019.

Authors+Show Affiliations

The Second People's Hospital of Hefei, Hefei Hospital Affiliated to Anhui Medical University, 246 Heping Road, Hefei, China.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.The Second People's Hospital of Hefei, Hefei Hospital Affiliated to Anhui Medical University, 246 Heping Road, Hefei, China.Key Laboratory of Oral Diseases Research of Anhui Province, Stomatological Hospital & College, Anhui Medical University, Hefei, China.Key Laboratory of Oral Diseases Research of Anhui Province, Stomatological Hospital & College, Anhui Medical University, Hefei, China. ql-li@126.com.The Second People's Hospital of Hefei, Hefei Hospital Affiliated to Anhui Medical University, 246 Heping Road, Hefei, China. u3001283@connect.hku.hk.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

32650814

Citation

Wu, Juncang, et al. "Using Metagenomic Analysis to Assess the Effectiveness of Oral Health Promotion Interventions in Reducing Risk for Pneumonia Among Patients With Stroke in Acute Phase: Study Protocol for a Randomized Controlled Trial." Trials, vol. 21, no. 1, 2020, p. 634.
Wu J, Dai Y, Lo ECM, et al. Using metagenomic analysis to assess the effectiveness of oral health promotion interventions in reducing risk for pneumonia among patients with stroke in acute phase: study protocol for a randomized controlled trial. Trials. 2020;21(1):634.
Wu, J., Dai, Y., Lo, E. C. M., Qi, Y., Zhang, Y., Li, Q. L., & Dai, R. (2020). Using metagenomic analysis to assess the effectiveness of oral health promotion interventions in reducing risk for pneumonia among patients with stroke in acute phase: study protocol for a randomized controlled trial. Trials, 21(1), 634. https://doi.org/10.1186/s13063-020-04528-3
Wu J, et al. Using Metagenomic Analysis to Assess the Effectiveness of Oral Health Promotion Interventions in Reducing Risk for Pneumonia Among Patients With Stroke in Acute Phase: Study Protocol for a Randomized Controlled Trial. Trials. 2020 Jul 10;21(1):634. PubMed PMID: 32650814.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Using metagenomic analysis to assess the effectiveness of oral health promotion interventions in reducing risk for pneumonia among patients with stroke in acute phase: study protocol for a randomized controlled trial. AU - Wu,Juncang, AU - Dai,Yuanchang, AU - Lo,Edward C M, AU - Qi,Yinliang, AU - Zhang,Ya, AU - Li,Quan-Li, AU - Dai,Ruoxi, Y1 - 2020/07/10/ PY - 2020/05/05/received PY - 2020/06/18/accepted PY - 2020/7/12/entrez PY - 2020/7/12/pubmed PY - 2020/7/12/medline KW - Metagenomic KW - Next-generation sequencing KW - Oral health promotion KW - Pneumonia complicating stroke KW - Randomized controlled trial SP - 634 EP - 634 JF - Trials JO - Trials VL - 21 IS - 1 N2 - BACKGROUND: 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. DISCUSSION: 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. TRIAL REGISTRATION: ClinicalTrials.gov NCT04095780 . Registered on 19 September 2019. SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/32650814/Using_metagenomic_analysis_to_assess_the_effectiveness_of_oral_health_promotion_interventions_in_reducing_risk_for_pneumonia_among_patients_with_stroke_in_acute_phase:_study_protocol_for_a_randomized_controlled_trial L2 - https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-020-04528-3 DB - PRIME DP - Unbound Medicine ER -
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