CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 94 enrolled
Drug / intervention
Powered toothbrush +3 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03003871
NCT03003871N/ACompleted

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.

The University of Hong Kong·interventional·Posted Dec 28, 2016·Updated Apr 17, 2017

In Brief

A clinical study evaluating Powered toothbrush, Manual toothbrush, and 2 other interventions for Stroke. Completed, enrolled 94 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStroke
Countries--
CollaboratorsTung Wah Hospital

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 28, 2016
Enrollment StartApr 1, 2013
Primary CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 9.5 years ago

Interventions

Powered toothbrushdevice

Oral-B® AdvancePowerTM 400 series

Manual toothbrushdevice

Oral-B® Pro-Health All-In-One

Toothpasteother

Colgate Maximum Cavity Protection®

0.2% chlorhexidine gluconate mouth rinseother

CorsodylPTMP