MISS NORMALIZA AM AB MALIK (Orcid ID : 0000-0002-0423-0837)

Accepted Article
Article type : Original Article

TITLE PAGE

Title: A multi-centre randomized clinical trial of oral hygiene interventions following

stroke – a 6-months trial.

Short title: Oral hygiene following stroke

Article category: Original article

Authors:

1. Normaliza Ab Malik (MClinDent)

Email: liza2013@hku.hk / liza_arie2004@yahoo.com

1. Periodontology and Dental Public Health

Faculty of Dentistry

The University of Hong Kong

34 Hospital Road

Hong Kong SAR

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

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 2. Faculty of Dentistry

Universiti Sains Islam Malaysia

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Level 15, Menara B MPAJ

Kuala Lumpur 55100

Malaysia.

2. Saari Mohamad Yatim (MRehabMed)

Email: saari_myatim@moh.gov.my
Department of Medical Rehabilitation,

Hospital Serdang,

43000 Kajang, Selangor,

Malaysia

3. Fathilah Abdul Razak (PhD)

Email: fathilah@um.edu.my

Department of Oral & Craniofacial Sciences,

Faculty of Dentistry,

University of Malaya,

50603 Kuala Lumpur,

Malaysia.

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 4. Otto Lok Tao Lam (PhD)

Email: ottolam@hku.hk
Accepted Article
Oral Rehabilitation,

Faculty of Dentistry

The University of Hong Kong

34 Hospital Road

Hong Kong SAR, China

5. Lijian Jin (PhD)

Email : ljjin@hku.hk
Periodontology and Dental Public Health

Faculty of Dentistry

The University of Hong Kong

34 Hospital Road

Hong Kong SAR, China

6. Leonard. S. W. Li (MD)

Email: lswli@hku.hk
Tung Wah Hospital,

12 Po Yan Street,

Sheung Wan,

Hong Kong SAR, China

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 7. Colman McGrath (PhD) - Corresponding Author

Email : mcgrathc@hku.hk
Accepted Article
Periodontology and Dental Public Health

Faculty of Dentistry

The University of Hong Kong

34 Hospital Road

Hong Kong SAR, China

Ph no: +85228590301

Fax no: +85228587874

- List of tables:

Table 1. Socio-demographic, dental and medical characteristic.

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

scores in stroke patients at 6-months.

Figure 1. Flow diagram of the clinical trial.

- Keywords: Cerebrovascular disease, Chlorhexidine, Clinical trial, Oral health promotion,

Dental plaque, Rehabilitation.

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 ABSTRACT

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

associated with dental plaque levels at follow-up at 6-months.

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 Introduction

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

medical complications 3, 4, such as stroke 5. Therefore removal of dental plaque is essential in

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

with cardiovascular diseases, cerebrovascular diseases, infective endocarditis, bacterial

pneumonia, low birth weight and diabetes mellitus 7

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

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 following a stroke that can give rise to aspiration pneumonia and this is of particular concern
19
in cases where dysphagia exists . The incidence rate of stroke-associated pneumonia in
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20, 21
Malaysia, ranges from 12.3 to 15.8% , comparable with other studies from different
22, 23
countries . Therefore, controlling dental plaque levels is of key importance following
24, 25
stroke to prevent the risk of developing pneumonia . The standard oral hygiene method

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

conjunction with tooth brushing to maintain oral health 26.

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

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 the effectiveness of two oral health promotion (OHP) interventions - a ‘Conventional’ and

‘Intense’ method in improving dental plaque levels following a stroke.

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Methods

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

clinical trial registration number of NMRR-13-1664-17247(IIR).

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%

Chlorhexidine gel (Hexigel® chlorhexidine gluconate gel). Computer-generated

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

performed at baseline, 3-months and 6-months.

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 One examiner was involved in the assessment of all patients at the three-time points. The

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,

deemed medically stable by attending physician, not receiving antibiotics or antimicrobial

agents and who were not edentulous. Written informed consent was obtained either from the

patient or their family members.

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

use, and socio-demographic information was also collected.

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 The primary outcome was the changes in the dental plaque score [PI scores]. A sample size

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-

out rates of 40%; at least 38 patients per group were required.

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

was assessed by the Mann-Whitney U. Univariate analyses regression was performed to

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

socio-demographic background (age group, gender, educational attainment and ethnicity),

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 stroke risk factors (alcohol and tobacco use), oral health state (denture status and PI score at

baseline), functional and cognitive status, and stroke features at baseline.

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Among the 86 patients at baseline, 60.5% (n=52) were male and 84.9% (n=73) were above

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

a significant difference in PI scores in both groups; baseline and 3-months (P <0.05), 3-

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

significant difference observed (p>0.05), (Table 2).

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

PI scores at 6-months. These factors remained significant in adjusted model 1; gender

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 (ß=0.41, P=0.005) and age (ß=0.015, P=0.003). Model 1 proved to be significant for 25.9%

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

43.6% of the variance).

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.

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 Dental plaque index scores were relatively high at baseline concurring with other reports of
44, 46
poor oral hygiene and plaque accumulation following stroke . However, it remains
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unclear as to how much this is contributed by pre-stroke oral health status48. Among the

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%

chlorhexidine gel as an alternate and it proved to be effective. Thus can be supported as an

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

findings in other studies using similar oral hygiene regimes.

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 The key predictors of plaque levels at 6-months were baseline plaque levels and functional

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

approximately 44% have moderate to severe disability51. Initial deficits immediately

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

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 56, 57
nurses, did not significantly reduce the dental plaque score of stroke survivors , even
57
though oral health attitude and knowledge improved with the intervention . However, a
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home-based study reported an improvement of dental plaque score when oral health care
58
training programmes were provided to the family members of stroke survivors . A case

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

among stroke patients.

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

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 care to maintain oral health among stroke survivors. Moreover, an additional support such as

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

plaque during stroke rehabilitation.

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

throughout the study.

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 Disclosures statement

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

1. Sharma P, Busby M, Chapple L, Matthews R, Chapple I. The relationship between general

health and lifestyle factors and oral health outcomes. British dental journal. 2016;221:65-69.
2. Batchelor P. The changing epidemiology of oral diseases in the elderly, their growing
importance for care and how they can be managed. Age and ageing. 2015;44:1064-1070.
3. Chalmers JM, Carter KD, Spencer AJ. Oral diseases and conditions in community‐living older
adults with and without dementia. Special Care in Dentistry. 2003;23:7-17.
4. Almomani F, Hamasha AA, Williams KB, Almomani M. Oral health status and physical, mental
and cognitive disabilities among nursing home residents in Jordan. Gerodontology.
2015;32:90-99.
5. Dickinson H. Maintaining oral health after stroke. Nursing standard. 2012;26:35-39.
6. Axelsson P, Lindhe J. Effect of controlled oral hygiene procedures on caries and periodontal
disease in adults. Journal of clinical periodontology. 1981;8:239-248.
7. Li X, Kolltveit KM, Tronstad L, Olsen I. Systemic diseases caused by oral infection. Clinical
microbiology reviews. 2000;13:547-558.
8. Lozano R, Naghavi M, Foreman K, et al. Global and regional mortality from 235 causes of
death for 20 age groups in 1990 and 2010: a systematic analysis for the Global Burden of
Disease Study 2010. Lancet. 2012;380:2095-2128.
9. Petrea RE, Beiser AS, Seshadri S, Kelly-Hayes M, Kase CS, Wolf PA. Gender differences in
stroke incidence and poststroke disability in the Framingham heart study. Stroke; a journal
of cerebral circulation. 2009;40:1032-1037.
10. Mozaffarian D, Benjamin EJ, Go AS, et al. Heart Disease and Stroke Statistics-2016 Update: A
Report From the American Heart Association. Circulation. 2016;133:e38-360.
11. MOH. Health Facts 2016. Ministry of Health, Malaysia. . Malaysia: Planning Division. Health
Informatics Centre.; August 2016.
12. Cheah WK, Hor CP, Zariah AA, Looi I. A Review of Stroke Research in Malaysia from 2000 -
2014. The Medical journal of Malaysia. 2016;71:58-69.
13. Hamidon BB, Nabil I, Raymond AA. Risk factors and outcome of dysphagia after an acute
ischaemic stroke. The Medical journal of Malaysia. 2006;61:553-557.
14. Mayo NE, Wood-Dauphinee S, Ahmed S, et al. Disablement following stroke. Disability and
rehabilitation. 1999;21:258-268.
15. Schimmel M, Leemann B, Schnider A, Herrmann FR, Kiliaridis S, Muller F. Changes in oro-
facial function and hand-grip strength during a 2-year observation period after stroke.
Clinical oral investigations. 2013;17:867-876.

This article is protected by copyright. All rights reserved.

 16. Zhu HW, McMillan AS, McGrath C, Li LS, Samaranayake LP. Oral carriage of yeasts and
coliforms in stroke sufferers: a prospective longitudinal study. Oral diseases. 2008;14:60-66.
17. Zuluaga DJ, Ferreira J, Montoya JA, Willumsen T. Oral health in institutionalised elderly
Accepted Article
people in Oslo, Norway and its relationship with dependence and cognitive impairment.
Gerodontology. 2012;29:e420-426.
18. Pons-Fuster A, Rodriguez Agudo C, Galvez Munoz P, Saiz Cuenca E, Pina Perez FM, Lopez-
Jornet P. Clinical evaluation of periodontal disease in patients with rheumatoid arthritis: A
cross-sectional study. Quintessence international. 2015;46:817-822.
19. Langmore SE, Terpenning MS, Schork A, et al. Predictors of aspiration pneumonia: how
important is dysphagia? Dysphagia. 1998;13:69-81.
20. Tajudin NAA, Ahmad M, Uduman A, Hamidon B. Predictors of stroke-associated pneumonia
after the first episode of acute ischaemic stroke. Malaysian Journal of Medicine and Health
Sciences. 2012;8:37-43.
21. Hamidon BB, Raymond AA, Norlinah MI, Jefferelli SB. The predictors of early infection after
an acute ischaemic stroke. Singapore medical journal. 2003;44:344-346.
22. Hannawi Y, Hannawi B, Rao CP, Suarez JI, Bershad EM. Stroke-associated pneumonia: major
advances and obstacles. Cerebrovascular diseases (Basel, Switzerland). 2013;35:430-443.
23. Ho YH, Liu HY, Huang ST. [The prevalence and signs of Dysphagia among stroke patients in
rehabilitation units]. Hu li za zhi The journal of nursing. 2014;61:54-62.
24. Millns B, Gosney M, Jack CI, Martin MV, Wright AE. Acute stroke predisposes to oral gram-
negative bacilli -- a cause of aspiration pneumonia? Gerontology. 2003;49:173-176.
25. El-Solh AA, Pietrantoni C, Bhat A, et al. Colonization of dental plaques: a reservoir of
respiratory pathogens for hospital-acquired pneumonia in institutionalized elders. Chest.
2004;126:1575-1582.
26. Mullane DM, Baez RJ, Jones S, et al. Fluoride and Oral Health. Community dental health.
2016;33:69.
27. Hugoson A, Lundgren D, Asklow B, Borgklint G. Effect of three different dental health
preventive programmes on young adult individuals: a randomized, blinded, parallel group,
controlled evaluation of oral hygiene behaviour on plaque and gingivitis. J Clin Periodontol.
2007;34:407-415.
28. Singh A. Oral health knowledge, attitude and practice among NCC Navy Cadets and their
correlation with oral hygiene in south India. Oral health & preventive dentistry. 2009;7:363-
367.
29. Martens L, Marks L, Goffin G, Gizani S, Vinckier F, Declerck D. Oral hygiene in 12-year-old
disabled children in Flanders, Belgium, related to manual dexterity. Community dentistry and
oral epidemiology. 2000;28:73-80.
30. Limeres J, Martinez F, Feijoo JF, Ramos I, Linares A, Diz P. A new indicator of the oral hygiene
habits of disabled persons: relevance of the carer's personal appearance and interest in oral
health. International journal of dental hygiene. 2014;12:121-126.
31. Yaacob M, Worthington HV, Deacon SA, et al. Powered versus manual toothbrushing for oral
health. The Cochrane database of systematic reviews. 2014:Cd002281.
32. Prasad KV, Sreenivasan PK, Patil S, Chhabra KG, Javali SB, DeVizio W. Removal of dental
plaque from different regions of the mouth after a 1-minute episode of mechanical oral
hygiene. American journal of dentistry. 2011;24:60-64.

This article is protected by copyright. All rights reserved.

 33. Philip G, Dayakar M, Divater V, Prasad S. Emerging concepts in oral chemical plaque control–
an overview. International Journal of Dental Clinics. 2012;4.
34. Lopez-Jornet P, Plana-Ramon E, Leston JS, Pons-Fuster A. Short-term side effects of 0.2%
Accepted Article
alcohol-free chlorhexidine mouthrinse in geriatric patients: a randomized, double-blind,
placebo-controlled study. Gerodontology. 2012;29:292-298.
35. Moran J, Newcombe RG, Wright P, Haywood J, Marlow I, Addy M. A study into the plaque-
inhibitory activity of experimental toothpaste formulations containing antimicrobial agents.
Journal of clinical periodontology. 2005;32:841.
36. Brady M, Furlanetto D, Hunter RV, Lewis S, Milne V. Staff-led interventions for improving
oral hygiene in patients following stroke. The Cochrane database of systematic reviews.
2006:CD003864.
37. Soh KL, Soh KG, Japar S, Raman RA, Davidson PM. A cross-sectional study on nurses' oral
care practice for mechanically ventilated patients in Malaysia. Journal of clinical nursing.
2011;20:733-742.
38. Soh KL, Shariff Ghazali S, Soh KG, Abdul Raman R, Sharif Abdullah SS, Ong SL. Oral care
practice for the ventilated patients in intensive care units: a pilot survey. Journal of infection
in developing countries. 2012;6:333-339.
39. Silness J, Löe H. Periodontal disease in pregnancy II. Correlation between oral hygiene and
periodontal condition. Acta odontologica Scandinavica. 1964;22:121-135.
40. Shah S, Vanclay F, Cooper B. Improving the sensitivity of the Barthel Index for stroke
rehabilitation. Journal of clinical epidemiology. 1989;42:703-709.
41. Folstein MF, Folstein SE, McHugh PR. “Mini-mental state”: A practical method for grading
the cognitive state of patients for the clinician. Journal of psychiatric research. 1975;12:189-
198.
42. Kim EK, Jang SH, Choi YH, et al. Effect of an oral hygienic care program for stroke patients in
the intensive care unit. Yonsei medical journal. 2014;55:240-246.
43. Dziura JD, Post LA, Zhao Q, Fu Z, Peduzzi P. Strategies for dealing with missing data in clinical
trials: from design to analysis. The Yale journal of biology and medicine. 2013;86:343-358.
44. Lam OL, McMillan AS, Samaranayake LP, Li LS, McGrath C. Randomized clinical trial of oral
health promotion interventions among patients following stroke. Archives of physical
medicine and rehabilitation. 2013;94:435-443.
45. Dai R, Lam OL, Lo EC, Li LS, McGrath C. A randomized clinical trial of oral hygiene care
programmes during stroke rehabilitation. Journal of dentistry. 2017.
46. Kim EK, Park EY, Sa Gong JW, Jang SH, Choi YH, Lee HK. Lasting effect of an oral hygiene care
program for patients with stroke during in-hospital rehabilitation: a randomized single-
center clinical trial. Disability and rehabilitation. 2016:1-6.
47. Schulz KF, Grimes DA. Sample size slippages in randomised trials: exclusions and the lost and
wayward. The Lancet. 2002;359:781-785.
48. Pow EH, Leung KC, Wong MC, Li LS, McMillan AS. A longitudinal study of the oral health
condition of elderly stroke survivors on hospital discharge into the community. International
dental journal. 2005;55:319-324.
49. 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;39:1042-1055.

This article is protected by copyright. All rights reserved.

 50. Mayo N. Epidemiology and recovery. Physical Medicine and Rehabilitation,Philadelphia,
Hanley & Belfus, Inc. . 1993;7:1-25.
51. Kelly-Hayes M, Beiser A, Kase CS, Scaramucci A, D’Agostino RB, Wolf PA. The influence of
Accepted Article
gender and age on disability following ischemic stroke: the Framingham study. Journal of
Stroke and Cerebrovascular Diseases. 2003;12:119-126.
52. Bonita R, Beaglehole R. Recovery of motor function after stroke. Stroke; a journal of cerebral
circulation. 1988;19:1497-1500.
53. Basmajian J, Gowland C, Brandstater M, Swanson L, Trotter J. EMG feedback treatment of
upper limb in hemiplegic stroke patients: a pilot study. Archives of physical medicine and
rehabilitation. 1982;63:613-616.
54. Ab. Malik N, M. Yatim S, Lam O, Jin L, McGrath C. Oral Health Care Guidelines, Training, and
Resources among Stroke Care Providers. JDR Clinical & Translational Research.
2017:2380084417693784.
55. Ab Malik N, Zhang J, Lam OL, Jin L, McGrath C. Effectiveness of computer-aided learning in
oral health among patients and caregivers - a systematic review. Journal of the American
Medical Informatics Association : JAMIA. 2016.
56. Frenkel H, Harvey I, Newcombe RG. Improving oral health in institutionalised elderly people
by educating caregivers: a randomised controlled trial. Community dentistry and oral
epidemiology. 2001;29:289-297.
57. Brady MC, Stott DJ, Norrie J, et al. Developing and evaluating the implementation of a
complex intervention: using mixed methods to inform the design of a randomised controlled
trial of an oral healthcare intervention after stroke. Trials. 2011;12:168.
58. Kuo YW, Yen M, Fetzer S, Lee JD, Chiang LC. Effect of family caregiver oral care training on
stroke survivor oral and respiratory health in Taiwan: a randomised controlled trial.
Community dental health. 2015;32:137-142.
59. Nishimura T, Takahashi C, Takahashi E. Dental hygiene residential care in a 3‐year dental
hygiene education programme in Japan: towards dysphagia management based on the
dental hygiene process of care. International journal of dental hygiene. 2007;5:145-150.
60. Kuo YW, Yen M, Fetzer S, et al. A home-based training programme improves family
caregivers' oral care practices with stroke survivors: a randomized controlled trial.
International journal of dental hygiene. 2015.
61. Ab Malik N, Mohamad Yatim S, Lam OL, Jin L, McGrath C. Factors influencing the provision of
oral hygiene care following stroke: an application of the Theory of Planned Behaviour.
Disability and rehabilitation. 2017:1-8.

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 Table 1. Socio-demographic, dental and medical characteristic.
Accepted Article
Baseline Complete
p-value p-value
Control Test Control Test
Fisher exact Fisher exact
n (%) n (%) n (%) n (%)
test^ test^
Gender
Female 20 (41.7%) 14 (36.8%) 0.650 12 (41.4%) 10 (40.0%) 0.918
Male 28 (58.3%) 24 (63.2%) 17 (58.6%) 15 (60.0%)
Age
20 – 39 years 7 (14.6%) 6 (15.8%) 0.877 5 (17.2%) 6 (24.0%) 0.539
40 ++ years 41 (85.4%) 32 (84.2%) 24 (82.8%) 19 (76.0%)
Ethnic group
Malay 35 (72.9%) 27 (71.1%) 0.872 22 (75.9%) 20 (80.0%) 0.715
Others 13 (27.1%) 11 (28.9%) 7 (24.1%) 5 (20.0%)
Education
Master’s/diploma 12 (25.0%) 4 (10.5%) 0.087 8 (27.6%) 3 (12.0%) 0.156
School/No education 36 (75.0%) 34 (89.5%) 21 (72.4%) 22 (88.0%)
Denture
No denture 38 (79.2%) 30 (78.9%) 0.980 22 (75.9%) 21 (84.0%) 0.459
Partial 10 (20.8%) 8 (21.1%) 7 (24.1%) 4 (16.0%)
Alcohol intake
No 42 (87.5%) 31 (81.6%) 0.447 26 (89.7%) 21 (84.0%) 0.692
Yes 6 (12.5%) 7 (18.4%) 3 (10.3%) 4 (16.0%)
Smoking
No 36 (75.0%) 30 (78.9%) 0.667 20 (69.0%) 21 (84.0%) 0.198
Yes 12 (25.0%) 8 (21.1%) 9 (31.0%) 4 (16.0%)
Stroke Incidence
Recurrent stroke 6 (12.5%) 5 (13.2%) 1.000^ 3 (10.3%) 3 (12.0%) 1.000^
First stroke 42 (87.5%) 33 (86.8%) 26 (89.7%) 22 (88.0%)
Stroke type
Haemorrhagic stroke 6 (12.5%) 3 (7.9%) 0.725^ 4 (13.8%) 2 (8.0%) 0.675^
Ischemic stroke 42 (87.5%) 35 (92.1%) 25 (86.2%) 23 (92.0%)
Hemiparesis side
Left side 30 (62.5%) 21 (55.3%) 0.498 17 (58.6%) 12 (48.0%) 0.435
Right side 18 (37.5%) 17 (44.7%) 12 (41.4%) 13 (52.0%)
Dominant hand
Left hand 3 (6.3%) 7 (18.4%) 0.099^ 2 (6.9%) 6 (24.0%) 0.125^
Right hand 45 (93.8%) 31 (81.6%) 27 (93.1%) 19 (76.0%)
MBI (0 month)
Tot/sev dependence 33 (68.8%) 28 (73.7%) 0.617 21 (72.4%) 18 (72.0%) 0.973
Mod/mild/min. dependence 15 (31.3%) 10 (26.3%) 8 (27.6%) 7 (28.0%)
MMSE (0 month)
Severe cognitive impairment 18 (37.5%) 15 (39.5%) 0.752 10 (34.5%) 10 (40.0%) 0.675
No/mild cognitive impairment 30 (62.5%) 23 (60.5%) 19 (65.5%) 15 (60.0%)
No. of comorbidities
≤1 comorbidities 22 (45.8%) 19 (50.0%) 0.701 17 (58.6%) 13 (52.0%) 0.625
≥2 comorbidities 26 (54.2%) 19 (50.0%) 12 (41.4%) 12 (48.0%)

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 Table 2. Within group and over time comparison of dental plaque scores changes.
Accepted Article
Baselinea 3 monthsb 6 monthsc
Mean (SD) Mean (SD) Mean (SD) p-value
Median (min,max) Median (min,max) Median (min,max)
Plaque index score
Control 1.78 (0.40) 1.31 (0.51) 1.07 (0.57) <0.001^^*
(n=29) 1.89 (0.83,2.33) 1.25 (0.33,2.64) 1.10 (0.07,1.98) a>b, p=0.017*
a>c, p=0.000*
b>c, p=0.009*

Test 1.76 (0.50) 1.27 (0.61) 0.92 (0.59) <0.001^^*

(n=25) 1.94 (0.44,2.36) 1.25 (0.08,2.47) 0.80 (0.00,2.53) a>b, p=0.049*
a>c, p<0.000*
b>c, p=0.014*

p-value 0.828^ 0.842^ 0.267^

 ^p-value derived from Mann-Whitney test

 ^^p-value derived from Friedman 2-way

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

Model 2 Coefficient p-value 95% CI Coefficient p-value 95% CI

Group -0.149 0.350 -0.46,0.17 -0.101 0.414 -0.35,0.15
Denture 0.531 0.005** 0.16,0.90 0.375 0.019* 0.06,0.69
PI_0mth 0.769 <0.001*** 0.48,1.06 0.702 <0.001*** 0.42,0.98

Model 3 Coefficient p-value 95% CI Coefficient p-value 95% CI

Group -0.149 0.350 -0.46,0.17 -0.128 0.298 -0.370.12
PI_0mth 0.769 <0.001*** 0.48,1.06 0.795 <0.001*** 0.52,1.07
MBI_0mth -0.270 0.125 -0.62,0.08 -0.340 0.016* -0.61,-0.07

#R2 adjusted Model 1 = 0.21, R2 adjusted Model 2 = 0.40, R2 adjusted Model 3 = 0.40

*p-value <0.05, **p-value <0.01, ***p-value <0.001

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Accepted Article

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