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.
Verified date | April 2017 |
Source | The University of Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 94 |
Est. completion date | December 2015 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 45 Years and older |
Eligibility |
Inclusion Criteria: 1. Admitted to participate in the Day Rehabilitation Center rehabilitation programme; 2. Had moderate to severe functional disability- Barthel Index (BI) scores of <70; 3. Able to follow a one-step command (as an assessment of communication) Exclusion Criteria: 1. edentulous; 2. more than mild cognitive ability- Mini Mental State Examination (MMSE) less than18; 3. had an indwelling naso-gastric feeding tubes. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
The University of Hong Kong | Tung Wah Hospital |
Lam CL, Tse EY, Gandek B. Is the standard SF-12 health survey valid and equivalent for a Chinese population? Qual Life Res. 2005 Mar;14(2):539-47. — View Citation
MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. — View Citation
Wong MC, Liu JK, Lo EC. Translation and validation of the Chinese version of GOHAI. J Public Health Dent. 2002 Spring;62(2):78-83. — View Citation
Wong MC, Lo EC, McMillan AS. Validation of a Chinese version of the Oral Health Impact Profile (OHIP). Community Dent Oral Epidemiol. 2002 Dec;30(6):423-30. — View Citation
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 Jan;14(1):60-6. doi: 10.1111/j.1601-0825.2006.01347.x. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | plaque index (PI) at 3 months | The PI was charted on all permanent teeth and assessed at six sites per tooth at 3 months. The criteria for the Silness and Löe Plaque are as following: 0 = No plaque detected with probe; 1 = Plaque not visible by unaided eye but detectable with probe; 2 = Moderate amount of plaque. Plaque visible to unaided eye; 3 = Abundance of plaque. The percentage of tooth sites with moderate to abundant plaque (PI score: 2 or 3) was calculated for each subject. | 3 months | |
Secondary | prevalence and viable counts of oral opportunistic pathogens at 3 months | The oral rinse samples were collected at 3 months. The oral rinse technique was used to detect oral opportunistic pathogens colonization in the whole oral cavity. A spiral plater (Spiral Systems Marketing Limited, Maryland, USA) was employed to inoculate the samples onto four selective cultural medium. Isolates on the above selective cultural medium were presumptively identified by colony morphology and the Gram stain method, and quantified by colony forming units (cfu/ml). | 3 months | |
Secondary | prevalence and viable counts of oral opportunistic pathogens at 6 months | The oral rinse samples were collected at 6 months. The oral rinse technique was used to detect oral opportunistic pathogens colonization in the whole oral cavity. A spiral plater (Spiral Systems Marketing Limited, Maryland, USA) was employed to inoculate the samples onto four selective cultural medium. Isolates on the above selective cultural medium were presumptively identified by colony morphology and the Gram stain method, and quantified by colony forming units (cfu/ml). | 6 months | |
Secondary | health-related quality of life (HRQL) at 3 months | The subjective health assessment included generic health-related quality of life (HRQL) and oral health-related quality of life (OHRQL) assessments. This consisted of the Cantonese versions of the Short Form Health Survey 12 (SF-12), the Oral Health Impact Profile 14 (OHIP-14), the Geriatric Oral Health Assessment Index (GOHAI). | 3 months | |
Secondary | health-related quality of life (HRQL) at 6 months | The subjective health assessment included generic health-related quality of life (HRQL) and oral health-related quality of life (OHRQL) assessments. This consisted of the Cantonese versions of the Short Form Health Survey 12 (SF-12), the Oral Health Impact Profile 14 (OHIP-14), the Geriatric Oral Health Assessment Index (GOHAI). | 6 months | |
Secondary | plaque index (PI) at 6 months | The PI was charted on all permanent teeth and assessed at six sites per tooth at 6 months. The criteria for the Silness and Löe Plaque are as following: 0 = No plaque detected with probe; 1 = Plaque not visible by unaided eye but detectable with probe; 2 = Moderate amount of plaque. Plaque visible to unaided eye; 3 = Abundance of plaque. The percentage of tooth sites with moderate to abundant plaque (PI score: 2 or 3) was calculated for each subject. | 6 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04043052 -
Mobile Technologies and Post-stroke Depression
|
N/A | |
Completed |
NCT04101695 -
Hemodynamic Response of Anodal Transcranial Direct Current Stimulation Over the Cerebellar Hemisphere in Healthy Subjects
|
N/A | |
Suspended |
NCT03869138 -
Alternative Therapies for Improving Physical Function in Individuals With Stroke
|
N/A | |
Completed |
NCT04034069 -
Effects of Priming Intermittent Theta Burst Stimulation on Upper Limb Motor Recovery After Stroke: A Randomized Controlled Trial
|
N/A | |
Terminated |
NCT03052712 -
Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies
|
N/A | |
Completed |
NCT00391378 -
Cerebral Lesions and Outcome After Cardiac Surgery (CLOCS)
|
N/A | |
Recruiting |
NCT06204744 -
Home-based Arm and Hand Exercise Program for Stroke: A Multisite Trial
|
N/A | |
Active, not recruiting |
NCT06043167 -
Clinimetric Application of FOUR Scale as in Treatment and Rehabilitation of Patients With Acute Cerebral Injury
|
||
Enrolling by invitation |
NCT04535479 -
Dry Needling for Spasticity in Stroke
|
N/A | |
Completed |
NCT03985761 -
Utilizing Gaming Mechanics to Optimize Telerehabilitation Adherence in Persons With Stroke
|
N/A | |
Recruiting |
NCT00859885 -
International PFO Consortium
|
N/A | |
Recruiting |
NCT06034119 -
Effects of Voluntary Adjustments During Walking in Participants Post-stroke
|
N/A | |
Completed |
NCT03622411 -
Tablet-based Aphasia Therapy in the Chronic Phase
|
N/A | |
Completed |
NCT01662960 -
Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke
|
N/A | |
Recruiting |
NCT05854485 -
Robot-Aided Assessment and Rehabilitation of Upper Extremity Function After Stroke
|
N/A | |
Active, not recruiting |
NCT05520528 -
Impact of Group Participation on Adults With Aphasia
|
N/A | |
Active, not recruiting |
NCT03366129 -
Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
|
||
Completed |
NCT03281590 -
Stroke and Cerebrovascular Diseases Registry
|
||
Completed |
NCT05805748 -
Serious Game Therapy in Neglect Patients
|
N/A | |
Recruiting |
NCT05621980 -
Finger Movement Training After Stroke
|
N/A |