Stroke Clinical Trial
Official title:
A Randomized Clinical Trial on the Effect of Powered Toothbrushing and an Antimicrobial Mouth Rinse on Dental Plaque, Pathogenic Microorganisms and Health of Stroke Survivors During Rehabilitation.
Stroke is the second most common cause of death worldwide and is the predominant cause of
permanent disability among older people. The mouth becomes a very unhealthy place after
stroke, where yeasts and pathogenic bacteria multiply at an accelerated rate. Poor oral
hygiene results in increased dental plaque, gingival bleeding, and the harbouring of oral
opportunistic pathogens. Dental plaque acts as a reservoir of pathogenic microorganisms
which results in additional oral health problems and also can cause life-threatening medical
complications; most notably aspiration pneumonia and/or recurrent stroke. The first six
months following stroke is a particular vulnerable period to survive.
Removal of dental plaque and its associated pathogenic microorganisms is challenging in this
compromised state of reduced manual dexterity and weak state following a stroke. Powered
(electric) toothbrushes can be of assistance in plaque removal in frail elders. For more
resistant oral pathogens, anti-plaque/anti-microbial mouthrinses can offer additional help
in controlling dental plaque and thereby prevent harbouring potentially life threatening
oral pathogens. Over the years the Faculty of Dentistry and the Stroke Rehabilitation Unit
of the Department of Medicine in Hong Kong have been actively working together to address
the problems of oral health associated with stroke; and specifically the challenge of
safeguarding the life and health of stroke survivors during the vulnerable rehabilitation
period. We are now proposing to involve stroke patients during out-patient rehabilitation in
a randomized clinical trial to test the effectiveness of powered tooth brushing and a
chlorhexidine anti-microbial mouthrinse in reducing dental plaque accumulation and oral
pathogens; and how this affects their general and oral health status. We anticipate that all
participants will benefit from the oral health promotion initiatives and that the advantages
will be long lasting. We expect to demonstrate a 'gold standard' of oral health preventive
care, as part of stroke rehabilitation, that can reduce (or has potential to reduce) serious
medical complications after a stroke. If proven effective this oral health preventive care
regime (which is relatively easy to implement and at low cost) could widely be adopted in
stroke rehabilitation globally.
The study population in this clinical trial will be patients with moderate to severe stroke
undergoing further stroke rehabilitation by returning regularly to the Day Rehabilitation
Center (on an out-patient basis) of the Rehabilitation Unit at Tung Wah Hospital (TWH). The
TWH Rehabilitation Unit, Sheung Wan, Hong Kong has been selected as the study site because
it serves a major urban area in Hong Kong. TWH is a medical teaching hospital, patient
medical care is standardized and a comprehensive set of records is compiled during stroke
rehabilitation. Around 500 patients with acute stroke are admitted annually to the
Rehabilitation Unit. The majority of the patients are stabilized (for up to 7 days) at Queen
Mary Hospital, a major teaching hospital for treating acute medical conditions, prior to
admission to the Rehabilitation Unit. On admission to the Rehabilitation Unit, each stroke
patient undergoes a comprehensive medical assessment that includes a functional disability
assessment using the modified Barthel Index and a rehabilitation programme is formulated.
Following hospital discharge, patients requiring further rehabilitation return regularly to
the Day Rehabilitation Center on an out-patient basis. Stroke patients deemed fit for
discharge from the Rehabilitation Unit will be invited to participate in the study in
accordance with the inclusion & exclusion criteria.
The key outcome variable of this clinical trial is the dental plaque level (the key
reservoir for oral pathogens). In a previous observational study we conducted among stroke
survivors, the mean PI score was 2.1 (standard deviation [SD]=0.51) at discharge and 1.9
(SD=0.56) at 6 months, yielding a change score of 0.21 (SD=0.46). On the basis of this
study, and proposing a difference in plaque change scores of at least 0.3 between baseline
to follow-up (and also between groups) and with the standard deviation set at 0.46, then the
number of study subjects that would be required is 38 per group, based on 80% power and the
statistical significance level set at 0.05. Anticipating a 20% dropout rate over the course
of the clinical trial, the initial sample size for each treatment group is proposed as 47
patients per group (94 subjects in total).
Assessments of clinical oral health status, presence of oral opportunistic pathogens and
subjective oral health were conducted at baseline, 3 month and 6 month. All assessments were
performed in the TWH Day Rehabilitation Center. Compliance was also assessed. Data will be
stored on a computer (and backed up on a compact disc) in the Faculty of Dentistry, The
University of Hong Kong. Professor Colman McGrath (Principle Investigator) will be
responsible for its safekeeping. All data will be kept until analyses have been performed
and all research manuscripts have been accepted for publication. The data will then be
destroyed.
The statistics software packages SPSS 21 for Windows (SPSS Inc., Chicago, USA) and STATA
13.0 for Windows (IBM) were used in all statistical tests. Both per-protocol (PP) and
intention-to-treat (ITT) analyses was employed for both primary and secondary outcomes. In
bivariate analyses, within and between groups comparisons were made over the clinical trial
period. When the outcome variables were continuous and followed a normal distribution,
paired t test for related samples were performed to determine significant differences over
time. Student t-test for independent samples was performed to compare the mean of the
outcomes between intervention groups at baseline and follow-up review. When the outcome
variables were continuous but did not follow a normal distribution as detected by normality
test, Wilcoxon Signed Rank test (a non-parametric equivalence of the paired t test for
related samples) was performed to determine significant differences over time. Mann Whitney
U test (a non-parametric equivalence of the t test for independent samples) was employed to
compare difference in the rank of outcomes between intervention groups at baseline and
follow-up. When the outcome variables were categorical, McNemar test were performed to
identify changes in prevalence over time and Chi-square test was employed to compare
variations in prevalence between intervention groups at baseline and follow up.
Regression analyses were employed to address the effect of potential explanatory factors for
outcomes. When conducting the regression analysis, method of Last Observation Carried
Forward (LOCF) was employed to deal with missing outcomes at follow-up reviews. Linear
regression was adopted when the dependent variables were continuous and residuals of the
regression followed a normal distribution. Negative binomial regression was adopted when the
continuous dependent variables had over-dispersed count data. Logistic regression was
adopted when the dependent variables were binary. Since the effect of intervention on the
outcomes was of our core interest, the model fitting adopted a forward-wald method with the
factor of intervention fixed in the model and one of the other explanatory factors added
into the model each time. Each time the coefficient of the independent variables with the
smallest significant p value (significance level p<0.05) was entered into the regression
model. The model fitting process was repeated again until no more independent variable had
significant p values.
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