Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2020

01-12-2020 | Stroke | Study protocol

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

Authors: Juncang Wu, Yuanchang Dai, Edward C. M. Lo, Yinliang Qi, Ya Zhang, Quan-li Li, Ruoxi Dai

Published in: Trials | Issue 1/2020

Login to get access

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
Appendix
Available only for authorised users
Literature
1.
Warlow C, Sudlow C, Dennis M, Wardlaw J, Sandercock P. Stroke. Lancet (London, England). 2003;362(9391):1211–24.CrossRef
2.
Krishnamurthi RV, Feigin VL, Forouzanfar MH, Mensah GA, Connor M, Bennett DA, et al. Global and regional burden of first-ever ischaemic and haemorrhagic stroke during 1990-2010: findings from the Global Burden of Disease Study 2010. Lancet Glob Health. 2013;1(5):e259–81.PubMedPubMedCentralCrossRef
3.
Kim AS, Johnston SC. Global variation in the relative burden of stroke and ischemic heart disease. Circulation. 2011;124(3):314–23.PubMedCrossRef
4.
Lai SM, Studenski S, Duncan PW, Perera S. Persisting consequences of stroke measured by the Stroke Impact Scale. Stroke. 2002;33(7):1840–4.PubMedCrossRef
5.
Dai R, Lam OL, Lo EC, Li LS, Wen Y, McGrath C. A systematic review and meta-analysis of clinical, microbiological, and behavioural aspects of oral health among patients with stroke. J Dent. 2015;43(2):171–80.PubMedCrossRef
6.
Dai R, Lam OL, Lo EC, Li LS, Wen Y, McGrath C. Orofacial functional impairments among patients following stroke: a systematic review. Oral Dis. 2015;21(7):836–49.PubMedCrossRef
7.
Lam OL, McMillan AS, Samaranayake LP, Li LS, McGrath C. Effect of oral hygiene interventions on opportunistic pathogens in patients after stroke. Am J Infect Control. 2013;41(2):149–54.PubMedCrossRef
8.
Zhu HW, McMillan AS, McGrath C, Li LS, Samaranayake LP. Oral carriage of yeasts and coliforms in stroke sufferers: a prospective longitudinal study. Oral Dis. 2008;14(1):60–6.PubMed
9.
Dai R, Lam OLT, Lo ECM, Li LSW, McGrath C. Effect of oral hygiene programmes on oral opportunistic pathogens during stroke rehabilitation. Oral Dis. 2019;25(2):617–33.PubMedCrossRef
10.
Sedgley CM, Samaranayake LP. The oral prevalence of aerobic and facultatively anaerobic gram-negative rods and yeasts in Hong Kong Chinese. Arch Oral Biol. 1994;39(6):459–66.PubMedCrossRef
11.
El-Solh AA, Pietrantoni C, Bhat A, Okada M, Zambon J, Aquilina A, et al. Colonization of dental plaques: a reservoir of respiratory pathogens for hospital-acquired pneumonia in institutionalized elders. Chest. 2004;126(5):1575–82.PubMedCrossRef
12.
Indredavik B, Rohweder G, Naalsund E, Lydersen S. Medical complications in a comprehensive stroke unit and an early supported discharge service. Stroke. 2008;39(2):414–20.PubMedCrossRef
13.
Langhorne P, Stott DJ, Robertson L, MacDonald J, Jones L, McAlpine C, et al. Medical complications after stroke: a multicenter study. Stroke. 2000;31(6):1223–9.CrossRefPubMed
14.
Katzan IL, Cebul RD, Husak SH, Dawson NV, Baker DW. The effect of pneumonia on mortality among patients hospitalized for acute stroke. Neurology. 2003;60(4):620–5.PubMedCrossRef
15.
Heuschmann PU, Kolominsky-Rabas PL, Misselwitz B, Hermanek P, Leffmann C, Janzen RW, et al. Predictors of in-hospital mortality and attributable risks of death after ischemic stroke: the German Stroke Registers Study Group. Arch Intern Med. 2004;164(16):1761–8.PubMedCrossRef
16.
Kalra L, Irshad S, Hodsoll J, Simpson M, Gulliford M, Smithard D, et al. Prophylactic antibiotics after acute stroke for reducing pneumonia in patients with dysphagia (STROKE-INF): a prospective, cluster-randomised, open-label, masked endpoint, controlled clinical trial. Lancet (London, England). 2015;386(10006):1835–44.CrossRef
17.
18.
Van Strydonck DA, Slot DE, Van der Velden U, Van der Weijden F. Effect of a chlorhexidine mouthrinse on plaque, gingival inflammation and staining in gingivitis patients: a systematic review. J Clin Periodontol. 2012;39(11):1042–55.PubMedCrossRef
19.
Locker D. Measuring oral health: a conceptual framework. Community Dent Health. 1988;5(1):3–18.PubMed
20.
Koboldt DC, Steinberg KM, Larson DE, Wilson RK, Mardis ER. The next-generation sequencing revolution and its impact on genomics. Cell. 2013;155(1):27–38.PubMedPubMedCentralCrossRef
21.
Smith CJ, Kishore AK, Vail A, Chamorro A, Garau J, Hopkins SJ, et al. Diagnosis of stroke-associated pneumonia: recommendations from the Pneumonia in Stroke Consensus Group. Stroke. 2015;46(8):2335–40.PubMedCrossRef
22.
23.
Silness J, Loe H. Periodontal disease in pregnancy. II. Correlation between oral hygiene and periodontal condition. Acta Odontol Scand. 1964;22:121–35.PubMedCrossRef
24.
Ainamo J, Bay I. Problems and proposals for recording gingivitis and plaque. Int Dent J. 1975;25(4):229–35.PubMed
25.
Petersen PE, Baez RJ, World Health O. Oral health surveys: basic methods, vol. 2013. 5th ed. Geneva: World Health Organization; 2013.
26.
Lam CL, Tse EY, Gandek B. Is the standard SF-12 health survey valid and equivalent for a Chinese population? Qual Life Res. 2005;14(2):539–47.PubMedCrossRef
27.
Wong MC, Lo EC, McMillan AS. Validation of a Chinese version of the Oral Health Impact Profile (OHIP). Community Dent Oral Epidemiol. 2002;30(6):423–30.PubMedCrossRef
28.
Wong MC, Liu JK, Lo EC. Translation and validation of the Chinese version of GOHAI. J Public Health Dent. 2002;62(2):78–83.PubMedCrossRef
29.
Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996;34(3):220–33.PubMedCrossRef
30.
Slade GD. Derivation and validation of a short-form oral health impact profile. Community Dent Oral Epidemiol. 1997;25(4):284–90.PubMedCrossRef
31.
Atchison KA, Dolan TA. Development of the Geriatric Oral Health Assessment Index. J Dent Educ. 1990;54(11):680–7.PubMedCrossRef
32.
Folstein MF, Folstein SE, McHugh PR. “Mini-mental state”. A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975;12(3):189–98.CrossRefPubMed
33.
Fields LB. Oral care intervention to reduce incidence of ventilator-associated pneumonia in the neurologic intensive care unit. J Neurosci Nurs. 2008;40(5):291–8.PubMedCrossRef
34.
Frenkel H, Harvey I, Needs K. Oral health care education and its effect on caregivers’ knowledge and attitudes: a randomised controlled trial. Community Dent Oral Epidemiol. 2002;30(2):91–100.PubMedCrossRef
35.
Gosney M, Martin MV, Wright AE. The role of selective decontamination of the digestive tract in acute stroke. Age Ageing. 2006;35(1):42–7.PubMedCrossRef
36.
Lam OL, McMillan AS, Samaranayake LP, Li LS, McGrath C. Randomized clinical trial of oral health promotion interventions among patients following stroke. Arch Phys Med Rehabil. 2013;94(3):435–43.PubMedCrossRef
37.
Kuo YW, Yen M, Fetzer S, Chiang LC, Shyu YI, Lee TH, et al. A home-based training programme improves family caregivers’ oral care practices with stroke survivors: a randomized controlled trial. Int J Dent Hyg. 2016;14(2):82–91.PubMedCrossRef
38.
Dai R, Lam OLT, Lo ECM, Li LSW, McGrath C. A randomized clinical trial of oral hygiene care programmes during stroke rehabilitation. J Dent. 2017;61:48–54.PubMedCrossRef
39.
Hua F, Xie H, Worthington HV, Furness S, Zhang Q, Li C. Oral hygiene care for critically ill patients to prevent ventilator-associated pneumonia. Cochrane Database Syst Rev. 2016;10:Cd008367.PubMed
Metadata
Title
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
Authors
Juncang Wu
Yuanchang Dai
Edward C. M. Lo
Yinliang Qi
Ya Zhang
Quan-li Li
Ruoxi Dai
Publication date
01-12-2020
Publisher
BioMed Central
Keywords
Stroke
Pneumonia
Published in
Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-020-04528-3

Other articles of this Issue 1/2020

Trials 1/2020 Go to the issue

Study protocol

Adjunct low-dose ketamine infusion vs standard of care in mechanically ventilated critically ill patients at a Tertiary Saudi Hospital (ATTAINMENT Trial): study protocol for a randomized, prospective, pilot, feasibility trial

Study protocol

Multi-dose Oral Ondansetron for Pediatric Gastroenteritis: study Protocol for the multi-DOSE oral ondansetron for pediatric Acute GastroEnteritis (DOSE-AGE) pragmatic randomized controlled trial

Study protocol

Efficacy of high-dose versus low-dose vitamin D supplementation on serum levels of inflammatory factors and mortality rate in severe traumatic brain injury patients: study protocol for a randomized placebo-controlled trial

Methodology

Cluster identification, selection, and description in cluster randomized crossover trials: the PREP-IT trials

Study protocol

Protocol for a multi-centre, definitive randomised controlled trial of the effectiveness of Individual Placement and Support for employment support among people with alcohol and drug dependence

Methodology

Treatment fidelity in the Tinnitus Retraining Therapy Trial