Oral Health Promotion Interventions Amongst Stroke Survivors During Rehabilitation

NCT03003871 | Completed

• 1 other identifier: GRF774012
• Study Type: interventional
• Target: 94
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Stroke

Keywords

stroke; randomized controled clinical trial; oral health promotion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• prevalence and viable counts of oral opportunistic pathogens at 3 months

  3 months

• prevalence and viable counts of oral opportunistic pathogens at 6 months

  6 months

• health-related quality of life (HRQL) at 3 months

  3 months

• health-related quality of life (HRQL) at 6 months

  6 months

• plaque index (PI) at 6 months

  6 months

Study Arms (2)

advanced oral hygiene care programmes

EXPERIMENTAL

participants were provided with a powered toothbrush (Oral-B® AdvancePowerTM 400 series), 0.2% chlorhexidine gluconate mouth rinse, 10 mls twice daily (CorsodylPTMP), standardized toothpaste (Colgate Maximum Cavity Protection) and oral hygiene instruction.

Device: Powered toothbrush; Other: Toothpaste; Other: 0.2% chlorhexidine gluconate mouth rinse

conventional oral hygiene care programme

ACTIVE COMPARATOR

participants were provided with a manual toothbrush (Oral-B® Pro-Health All-In-One), supply of a standardized toothpaste (Colgate Maximum Cavity Protection®) and oral hygiene instruction

Device: Manual toothbrush; Other: Toothpaste

Interventions

Powered toothbrush DEVICE

Oral-B® AdvancePowerTM 400 series

advanced oral hygiene care programmes

Manual toothbrush DEVICE

Oral-B® Pro-Health All-In-One

conventional oral hygiene care programme

Toothpaste OTHER

Colgate Maximum Cavity Protection®

advanced oral hygiene care programmes; conventional oral hygiene care programme

0.2% chlorhexidine gluconate mouth rinse OTHER

CorsodylPTMP

advanced oral hygiene care programmes

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Admitted to participate in the Day Rehabilitation Center rehabilitation programme;
• Had moderate to severe functional disability- Barthel Index (BI) scores of \<70;
• Able to follow a one-step command (as an assessment of communication)

You may not qualify if:

• edentulous;
• more than mild cognitive ability- Mini Mental State Examination (MMSE) less than18;
• had an indwelling naso-gastric feeding tubes.

Sponsors & Collaborators

• The University of Hong Kong: lead
• Tung Wah Hospital: collaborator

Related Publications (5)

• MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. No abstract available.

  PMID: 14258950 BACKGROUND

• 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. doi: 10.1007/s11136-004-0704-3.

  PMID: 15892443 BACKGROUND

• 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. doi: 10.1111/j.1752-7325.2002.tb03426.x.

  PMID: 11989210 BACKGROUND

• 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. doi: 10.1034/j.1600-0528.2002.00013.x.

  PMID: 12453113 BACKGROUND

• 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.

  PMID: 18173450 BACKGROUND

MeSH Terms

Conditions

Stroke

Interventions

Toothpastes

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dentifrices; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Colman McGrath, PhD

  Facluty of Dentistry, the University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 9, 2016
• First Posted: December 28, 2016
• Study Start: April 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 17, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share