Oral Health Promotion Interventions Amongst Stroke Survivors During Rehabilitation

NCT03003871 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2017-04-17

No results posted yet for this study

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

Interventions

DEVICE

Powered toothbrush

Oral-B® AdvancePowerTM 400 series

DEVICE

Manual toothbrush

Oral-B® Pro-Health All-In-One

OTHER

Toothpaste

Colgate Maximum Cavity Protection®

OTHER

0.2% chlorhexidine gluconate mouth rinse

CorsodylPTMP

Sponsors & Collaborators

  • Tung Wah Hospital

    collaborator OTHER
  • The University of Hong Kong

    lead OTHER

Principal Investigators

  • Colman McGrath, PhD · Facluty of Dentistry, the University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2015-12-31
Completion
2015-12-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03003871 on ClinicalTrials.gov