Title Page: MISS NORMALIZA AM AB MALIK (Orcid ID: 0000-0002-0423-0837)
Title Page: MISS NORMALIZA AM AB MALIK (Orcid ID: 0000-0002-0423-0837)
Title Page: MISS NORMALIZA AM AB MALIK (Orcid ID: 0000-0002-0423-0837)
Accepted Article
Article type : Original Article
TITLE PAGE
Authors:
Faculty of Dentistry
34 Hospital Road
China
This article has been accepted for publication and undergone full peer review but has not
been through the copyediting, typesetting, pagination and proofreading process, which may
lead to differences between this version and the Version of Record. Please cite this article as
doi: 10.1111/joor.12582
Malaysia.
Email: [email protected]
Department of Medical Rehabilitation,
Hospital Serdang,
Malaysia
Email: [email protected]
Faculty of Dentistry,
University of Malaya,
Malaysia.
Email: [email protected]
Accepted Article
Oral Rehabilitation,
Faculty of Dentistry
34 Hospital Road
Email : [email protected]
Periodontology and Dental Public Health
Faculty of Dentistry
34 Hospital Road
6. Leonard. S. W. Li (MD)
Email: [email protected]
Tung Wah Hospital,
12 Po Yan Street,
Sheung Wan,
Email : [email protected]
Accepted Article
Periodontology and Dental Public Health
Faculty of Dentistry
34 Hospital Road
Ph no: +85228590301
- List of tables:
Table 2. Within group and over time comparison of dental plaque scores changes.
Table 3. Multiple linear regression analyses to predict factors associated with dental plaque
Background: Maintaining good oral hygiene is important following stroke. Objectives: This
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study aimed to evaluate the effectiveness of two oral health promotion (OHP) programmes to
reduce dental plaque levels following stroke. Methods: A multi-center randomized clinical
control trial was conducted among patients hospitalised following stroke in Malaysia.
Patients were randomly allocated to two OHP groups: i) control group who received the
conventional method for plaque control - daily manual tooth brushing with a standardized
commercial toothpaste, ii) test group - who received an intense method for plaque control -
daily powered tooth brushing with 1% Chlorhexidine gel. Oral health assessments were
performed at baseline, at 3-months and 6-months post intervention. Within and between
group changes in dental plaque were assessed over time. Regression analyses were conducted
on dental plaque levels at 6-months controlling for OHP group, medical, dental and socio-
demographic status. Results: The retention rate was 62.7% (54/86 subjects). Significant
within-group changes of dental plaque levels were evident among the test group (p<0.001)
and the control group (p<0.001). No significant between-group changes of dental plaque
levels were apparent (p>0.05). Regression analyses identified that baseline plaque levels
(adjusted ß=0.79, p<0.001) and baseline functional dependency level (adjusted ß=-0.27,
p<0.05) were associated with dental plaques levels at the end of the trial (6-months).
Conclusion: Both, ‘Conventional’ and ‘Intense’ oral health promotion programmes may
successfully reduce dental plaque during stroke rehabilitation and are of comparable
effectiveness. Baseline dental plaque levels and functional dependency level were key factors
Oral health is integral to general health status and health-related quality of life 1. As life
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expectancy increases, the issues related to oral and general health increases. People are
retaining more teeth at an older age, and poor oral health may have impacts which extend
beyond the oral cavity, and affect systemic health and quality of life 2. Periodontal disease,
dental caries and denture related oral mucosal lesions are the commonest oral diseases
observed with increasing age, with the risk and severity increasing with the presence of
preventing the development of periodontal diseases, and other oral and medical health
problems 6. In addition, the oral health status, particularly periodontal health is associated
8, 9
Stroke is a major cause of chronic adult disability worldwide , and mortality for people
aged 60 and above 10. In Malaysia, stroke is the third leading (7.1%, n=5474) cause of death
after ischemic heart disease (13.5%, n=10,432) and pneumonia (12.0%, n=9,250), and ranks
11
among the top five causes of hospitalization . The stroke incidence rate is 67 per 100,000
people, with a mean onset age ranging from 41.5 years to 62.6 years 12. Approximately 41%
of stroke survivors present with dysphagia and this decreases to half at 1-month post stroke
13 14
. Stroke causes a range of functional impairments and physical disability . Besides, the
oral function of normal clearance is often compromised following stroke, and this contributes
15 16
to increased levels of dental plaque and carriage of microbiota . Dental plaque can
develop at an accelerated rate when oral hygiene practices are impaired 17, and/or the body’s
18
immune system is compromised . Of key concern is the aspiration of oral pathogens
for dental plaque control is by physical removal via daily tooth brushing. Fluoride toothpaste
provides an anti-caries effect, and has been the commonest cleansing agent used in
Besides, the effectiveness of ‘standard oral hygiene care’ is highly dependent on many factors
27 28 29
such as the awareness of the importance of oral hygiene , attitudes , manual dexterity
30
and environmental factors . As a result, more intensive physical means to improve oral
hygiene have been developed such as powered toothbrush that is more effective in removing
dental plaque compared to standard method 31. However, removal of dental plaque solely by
tooth brushing means was found to be inefficient32. Therefore, for patients with functional
disability, additional means of plaque control is highly suggested to achieve an optimal level
33
of oral hygiene . The use of chemical agents in intensive oral hygiene programmes has
34
been advocated largely in the form of mouth rinses . Although a ‘standard oral hygiene
35
care’ method using fluoride toothpaste has been shown to have plaque inhibitory effects ,
the extent of its effectiveness compared with chlorhexidine for stroke patients is yet to be
determined, and it still remains unclear what approaches are effective to inform practice in
36
stroke rehabilitation . In Malaysia, there is growing recognition of the importance of oral
37, 38
care in hospitalised settings, but studies have been limited to the intensive care unit . A
lack of evidence to inform oral health promotion interventions among stroke survivors has
led to the development of the current study. Thus, this study aimed to evaluate and compare
A randomized clinical control trial was conducted from June 2015 to August 2016 at five
public hospitals in Malaysia. Ethical approval was granted from the Medical Research and
Ethics Committee (MREC) of the National Institutes of Health, Ministry of Malaysia with a
Patients were block randomized into two groups, in a group size of four (ABBA). The control
group - received the ‘conventional method for plaque control’ - daily manual tooth brushing
(Oral-B®- super thin and extra soft bristles), with a standardized commercial toothpaste
(Colgate® Maximum Cavity Protection), and the test group received an ‘intense method for
plaque control’ - daily powered tooth brushing (Oral B® Pro-Health DB4010), with a 1%
randomization sequences were used for the random allocation of the patients, and this was
performed by the head of the research team. The oral hygiene kits were prepared by a dental
assistant who was not involved in oral health assessments and sample collections. Each oral
hygiene kit was placed in the same type of packaging, colour coded and was not transparent.
Individual oral hygiene instruction was given by the dental assistant, using a plastic tooth
model and a pamphlet on tooth brushing techniques. The study was single-blind, whereby
patient’s allocation was kept anonymous from the examiner. Oral health assessments were
examiner was trained on the oral assessment by the head of the research team, and functional
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assessments (MBI) by a rehabilitation physician before commencing with the study. Intra-
examiner reliability was performed with 10% of the participants at each time point. The
Kappa values of the PI score at baseline, 3-months and 6-months were 0.746, 0.842 and 0.892
respectively.
Inclusion criteria were hospitalised stroke patients managed by a stroke rehabilitation team
with a Modified Barthel Index (MBI) score of less than 70, cognizant to follow instructions,
agents and who were not edentulous. Written informed consent was obtained either from the
Dental plaque score was assessed following the methods and criteria of the Silness and Löe
plaque index 39. The plaque index (PI) records level of dental plaque at six sites per tooth: 3 =
abundance present of plaque, 2= visible plaque along the gingival margin, 1 = thin film of
plaque which is not visible with naked eyes but can be removed by a dental probe, and 0 =
absence of plaque. Presence and type of dental prosthesis was recorded. Functional
40
dependency level was assessed using the Modified Barthel Index (MBI) score and
cognitive mental status score was assessed by the ‘Mini-Mental State Examination’ (MMSE)
41
. Information on stroke type, stroke incidence (first or recurrent), hemiparesis, number of
co-morbidities and dominant hand affected was obtained. History of smoking and alcohol
of 23 subjects per group was calculated based on the detection of a clinically meaningful PI
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change score of 0.55 an anticipated SD of 0.6 42 and 80% power.To allow for potential drop-
Profile of test and control group were compared pre and post clinical trial employing Chi-
square tests. Within group changes in PI scores overtime was assessed using Friedman 2-
way ANOVA and pairwise comparisons. Between-group difference in PI at each time point
determine factors associated with PI scores at the end of the clinical trial. Multiple linear
regression models (stepwise) were conducted to determine the effect of OHP programme,
baseline oral health state, functional and cognitive status, stroke features, stroke risk factors,
and socio-demographics.
Results
A total of 151 stroke survivors were assessed for eligibility. A total of 65 patients were
excluded, and this comprised; patients who did not meet the inclusion criteria (n=48);
declined to participate in the study (n=2); lived outside the Klang Valley (n=8); and were
discharged before the visit (n=7). A total of 86 stroke survivors were recruited at baseline.
Overall, 54 (62.7%) patients were assessed throughout the three-time points (Figure1). There
was no significant difference in the profile of patients who completed the study and those
who did not complete the clinical trial (P>0.05). They did not differ with respect to their
the age of 40. Approximately 72.1% (n=62) were of Malay ethnicity. Most (79.1%, n=68) did
not have a removable dental prosthesis. For more than three-quarter of the patients it was
their first-stroke (87.2%, n=75) and of the ischemic type (89.5%, n=77). A high percentage of
patients (70.9%, n=61) were at severe to total dependency level with MBI score range less
than 50, and above a quarter had a severe cognitive impairment (MMSE) (38.4%, n=33).
There was no significant difference between the control and test groups (P >0.05) (Table 1).
Dental plaque index scores were high before the intervention; control group (mean=1.78, SD
0.40) and test group (mean=1.76, SD 0.50). A significant difference was noted in PI scores at
the end of the trial for both groups (control group; P <0.001, test group; P <0.001). There was
months and 6-months (P<0.05) and baseline and 6-months (P<0.001). The PI scores were
lower in the test group compared to the control group at 6-months, but there was no
Table 3 presents findings from the univariate analysis and stepwise multiple linear regression
analysis to identify factors associated with dental plaque scores at 6-months. In the
unadjusted model, gender (ß=0.37, P=0.20) and age (ß=0.013, P=0.016) were associated with
of the variance in predicting PI scores at 6-months. In Model 2, when controlling for socio-
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demographic and stroke risk factors; denture status (ß=0.37, P=0.019) and baseline PI scores
((ß=0.70, P<0.001) were associated with the PI scores at 6-months (significant for 43.3% of
the variance). In the final adjusted Model 3; PI scores ((ß=0.79, P<0.001) and MBI scores
(ß=-0.34, P=0.016) were associated with PI scores at 6-months (significant and accounted for
Discussion
This study aimed to evaluate the effectiveness of two oral health promotion (OHP)
programmes interventions following stroke. More than a third did not complete the study for
a variety of reasons ranging from medical complications and death to loss of contact with
rehabilitation centers. In addition, the long follow-up interval, lack of monetary incentive,
and the large number of assessments, and amount of information collected during each face
43
to face evaluation may have contributed to the high drop-out rate . Moreover, little
awareness on the importance of oral health compared with their general health may have
further contributed to the loss of data. The retention rate is indicative of studies among frail
patients and comparable to other oral health promotion intervention studies among stroke
42, 44
survivors . Missing data is not an uncommon scenario in many types of clinical trial
research, and this includes trials related to oral health promotion among stroke survivors 44-46.
These studies have documented a consistently high dropout rate, greater than recommended
47
level of 20% . Therefore, it is recommended that future studies conducted amongst stroke
survivors and other frail patient group account for a higher dropout rate.
group who had received the ‘conventional’ method of plaque control, daily tooth brushing
with commercially available toothpaste, there were significant improvements in dental plaque
levels over the 6-months period and this was observed within 3-months. While the ‘intensive’
method of plaque control involved combined physical and chemical means - powered tooth
brushing and chlorhexidine gel showed significant improvements in dental plaque levels over
the 6-months period, as well as within 3-months period. The effectiveness of powered
toothbrush for plaque control among stroke patients has been shown 44. The chemical control
of dental plaque has also been advocated particularly where conventional physical means of
49
plaque control is difficult to maintain; and specifically to the use of chlorhexidine .
Chlorhexidine mouth rinse (0.2%) twice daily in conjunction with powered tooth brushing
was effective in reducing dental plaque levels in a 3-week in-hospital clinical trial among
44
stroke survivors . The delivery of chlorhexidine by mouth rinsing may pose problems
among patients with dysphagia and thus the current study investigated the use of 1.0%
alternative approach in case of dysphagia. Between-group comparisons over time did not
identify any significant difference in plaque levels suggesting that both the ‘conventional’
and ‘intense’ method were of comparable effectiveness. This would suggest that a simple and
relatively inexpensive approach of manual tooth brushing with tooth paste be promoted in
stroke rehabilitation care. It would however be useful for others to confirm or refute such
dependency levels (MBI). Pre-existing plaque levels are known to influence outcome in
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plaque control studies. Those with high level of functional dependency at baseline had higher
levels of dental plaque at the end of trial, than those with low to moderate levels of functional
dependency. Studies have shown that more than half of the patients are commonly left with
hemiparesis or hemiplegia after the onset of stroke, ranging from 57% to 92% 50. A study on
ischemic stroke reported that hemiparesis affects 85% of stroke patients following stroke,
and at 6-months more than half (56%) of the patients have no or minimal disability, and
following stroke are associated with the prognosis for recovery. Patients with severe motor
impairments at baseline are ten times less likely to recover compared with patients with less
52
motor impairment . Studies have also reported that the majority of spontaneous functional
recovery is usually limited to the first 6-months after the onset of stroke 50. However, upper
limb impairment has the poorest prognosis, as only 5% of stroke survivors are expected to
regain their normal arm function, and little improvement is observed with intensive
53
rehabilitation treatment . Therefore, this has implications for future trials to consider the
effects of more intensive oral hygiene approaches involving more frequent or higher
concentrations of chemical agents among those with higher levels of functional dependency.
Functional motor deficits are common among stroke survivors, therefore they usually require
an assistant to perform their daily activities54. Thus the role of caregivers, either family
members or health care providers such as nurses, is crucially important in maintaining their
oral health. Interventions towards educating the caregivers, to improve and maintain oral
36, 55
health among stroke survivors have been studied, but the evidence is limited . Studies
have shown that implementation of oral health care education interventions for stroke-care
study reported that training dental hygienists in professional oral hygiene care methods
reduced plaque accumulation and minimize the risk of pneumonia in bed-bound stroke
59
patients . Thus, oral hygiene care interventions should be emphasised among stroke
caregivers to maintain good oral health among stroke survivors. Improvement in attitude,
intention and knowledge among stroke-caregivers may enhance their oral care practices to
stroke survivors 60, 61. Further research in this area is essential to achieve optimal oral health
The current study benefits from being a long-term study of plaque control over a six-month
period from hospitalised stroke rehabilitation to outpatient rehabilitation. This study involved
the randomization of patients to intervention and control groups within hospitals, as it was
not practical to randomly allocate hospitals due to the variable number of referred cases
among the centres. Nonetheless, direct observation of oral hygiene practices was not feasible
to obtain through the study and compliance was to a large extent of self-reports by the
patients. While the current study showed that the use of chlorhexidine is more effective in
reducing the dental plaque score, further studies are recommended with larger sample sizes
and different patient groups. The interventions may be implemented to patients with a similar
condition, such as with functional impairments or dependent individuals in which good oral
hygiene practices are compromised. The effects on stroke-associated pneumonia may require
longitudinal study beyond 6-months. Although the loss to follow-up may contribute to
withdrawal bias, the findings suggest that there is a need to take into account oral hygiene
assistance in performing daily oral hygiene or oral health awareness among the caregivers
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may need to be considered especially for those with severe stroke conditions.
Conclusion
This clinical trial demonstrated oral health promotion interventions are effective at reducing
dental plaque among patients hospitalised following stroke. Although there was insufficient
evidence to support preference of one regime over the other, these preliminary findings
highlighted the importance of oral hygiene care among stroke survivors. The conventional
oral hygiene regime of manual tooth brushing with commercially viable toothpaste twice
daily is supported given that it is a relative simple and inexpensive means to control dental
Acknowledgments
The authors would like to thank all patients, caregivers and personnel involved in this study.
We also would like to thank the Director General, Ministry of Health Malaysia, hospital’s
directors, and head of rehabilitation departments for their permission for the study to be
conducted, and to rehabilitation physicians and medical officers for their assistance
The authors have stated explicitly that there are no conflicts of interest in connection with this
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article. The study was funded by The University of Hong Kong.
References
Table 3. Multiple linear regression analyses to predict factors associated with dental plaque
scores in stroke patients at 6-months.
Unadjusted Adjusted#
Model 1 Coefficient p-value 95% CI Coefficient p-value 95% CI
Group -0.149 0.350 -0.46,0.17 -0.203 0.156 -0.48,0.08
Gender 0.367 0.020* 0.06,0.67 0.414 0.005** 0.13,0.70
Age 0.013 0.016* 0.01,0.24 0.015 0.003** 0.01,0.02
#R2 adjusted Model 1 = 0.21, R2 adjusted Model 2 = 0.40, R2 adjusted Model 3 = 0.40