Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2025 Sep 16;14(18):e040677.
doi: 10.1161/JAHA.124.040677. Epub 2025 Sep 11.

CHOSEN: A Randomized Controlled Feasibility Trial

Craig J Smith  1   2 , Andrew Brand  3 , Zoe Hoare  3 , Eileen Jones  1 , Catherine Davidson  4 , Wendy Westoby  5 , Ian Clements  5 , Fiona Sandom  6 , Clare Gross  7 , Anu Thomas  8 , Lucy Talbot  9 , Narayanamoorthi Saravanan  10 , Marian C Brady  11 , Peter Langhorne  12 , Giles I McCracken  13 , Catherine E Lightbody  4 , Caroline L Watkins  4 , Paul R Brocklehurst  14
Affiliations
Randomized Controlled Trial

CHOSEN: A Randomized Controlled Feasibility Trial

Craig J Smith et al. J Am Heart Assoc. .

Abstract

Background: Improving oral health in patients with acutely dysphagic stroke is a plausible approach to prevent pneumonia. We aimed to determine whether a phase 3, definitive trial of oral health care (OHC) treatments, supported by staff education and training, is feasible in stroke unit care.

Methods: The CHOSEN (Chlorhexidine or Toothpaste, Manual or Powered Brushing to prevent Pneumonia Complicating Stroke) trial was conducted and reported in line with the Consolidated Standards of Reporting Trials 2010 statement extended to feasibility trials. We aimed to recruit 120 participants with acute stroke and dysphagia within 24 hours of admission, from 4 stroke units in the northwest of England, randomized (1:1:1:1) to 1 of 4 OHC treatments: manual toothbrush or powered toothbrush with either nonfoaming toothpaste or chlorhexidine 1% gel. Stroke unit nursing staff received standardized education and training. Feasibility was assessed using a priori criteria.

Results: Between January 2022 and end of January 2023, 626 patients were screened. A total of 101 participants (median age, 73 [interquartile range, 62-80] years; median National Institutes of Health Stroke Scale score, 10 [interquartile range, 5-18]; 44% women) were enrolled (77% of eligible patients approached). Adherence was 91%, with no substantial difference between the OHC treatments, and 88% completed follow-up. There were 19 serious adverse events but no marked differences between allocated OHC treatments. In exploratory secondary analyses, again there were no substantial differences in survival, incident pneumonia, modified Rankin Scale score, or quality of life at 3 months between the OHC treatment allocations.

Conclusions: OHC treatments incorporating chlorhexidine and powered brushing and supported by standardized staff training appeared feasible and safe in patients with acutely dysphagic stroke. Progression criteria were met for a definitive trial of efficacy and cost effectiveness.

Registration: URL: https://doi.org/10.1186/ISRCTN52421361; Unique identifier: ISRCTN52421361.

Keywords: chlorhexidine; oral health care; poststroke pneumonia; randomized trial; stroke, acute.

PubMed Disclaimer

Conflict of interest statement

Oral B provided the powered brushes for the trial but had no other involvement in the trial design, conduct, analyses, or manuscript preparation.

Figures

Figure 1
Figure 1. Study Consolidated Standards of Reporting Trials flow diagram.
CH‐MAN indicates chlorhexidine with manual brushing; CH‐POW, chlorhexidine with powered brushing; TP‐MAN, nonfoaming toothpaste with manual brushing; and TP‐POW, nonfoaming toothpaste with powered brushing.
Figure 2
Figure 2. Stacked bar chart showing distribution of mRS scores by treatment allocation at (A) discharge, and (B) 3 months.
CH‐MAN indicates chlorhexidine with manual brushing; CH‐POW, chlorhexidine with powered brushing; mRS, modified Rankin Scale; TP‐MAN, nonfoaming toothpaste with manual brushing; and TP‐POW, nonfoaming toothpaste with powered brushing.
Figure 3
Figure 3. Occurrence of pneumonia by treatment allocation by (A) 7–10 days post‐randomization, and at (B) discharge from hospital.
Data are percentage with 95% CI. CH‐MAN indicates chlorhexidine with manual brushing; CH‐POW, chlorhexidine with powered brushing; TP‐MAN, nonfoaming toothpaste with manual brushing; and TP‐POW, nonfoaming toothpaste with powered brushing.
Figure 4
Figure 4. Survival at 3 months by treatment allocation.
Data are percentage with 95% CI. CH‐MAN indicates chlorhexidine with manual brushing; CH‐POW, chlorhexidine with powered brushing; TP‐MAN, nonfoaming toothpaste with manual brushing; and TP‐POW, nonfoaming toothpaste with powered brushing.
See this image and copyright information in PMC

References

    1. Lobo Chaves MA, Gittins M, Bray BD, Vail A, Smith CJ. Do stroke care processes modify clinical outcomes in patients with stroke‐associated pneumonia? A registry cohort study in England and Wales. Cerebrovasc Dis. 2023;52:21–27. doi: 10.1159/000524917 - DOI - PubMed
    1. Ali AN, Howe J, Majid A, Redgrave J, Pownall S, Abdelhafiz AH. The economic cost of stroke‐associated pneumonia in a UK setting. Top Stroke Rehabil. 2018;25:214–223. doi: 10.1080/10749357.2017.1398482 - DOI - PubMed
    1. Xu J, Yalkun G, Wang M, Wang A, Wangqin R, Zhang X, Chen Z, Mo J, Meng X, Li H, et al. Impact of infection on the risk of recurrent stroke among patients with acute ischemic stroke. Stroke. 2020;51:2395–2403. doi: 10.1161/STROKEAHA.120.029898 - DOI - PubMed
    1. Gittins M, Lobo Chaves M, Vail A, Smith CJ. Does stroke‐associated pneumonia play an important role on risk of in‐hospital mortality associated with severe stroke? A four‐way decomposition analysis of a national cohort of stroke patients. Int J Stroke. 2023;18:1092–1101. doi: 10.1177/17474930231177881 - DOI - PMC - PubMed
    1. Kishore A, Vail A, Bray BD, Chamorro A, Di Napoli M, Kalra L, Langhorne P, Montaner J, Roffe C, Rudd AG, et al. Clinical risk scores for predicting stroke‐associated pneumonia: a systematic review. Eur Stroke J. 2016;1:76–84. doi: 10.1177/2396987316651759 - DOI - PMC - PubMed

Publication types

MeSH terms

LinkOut - more resources