A Randomized Clinical Trial of Oral Health Promotion Interventions Among Patients After Stroke

NCT ID: NCT01265043

Last Updated: 2021-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2011-05-31

Brief Summary

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The main aim of this oral health intervention project is to compare the effect of providing 1) professional oral hygiene instruction alone versus 2) professional oral hygiene instruction plus adjunctive Chlorhexidine mouth rinse versus 3) professional oral hygiene instruction plus adjunctive assisted tooth brushing and Chlorhexidine mouth rinse, on the oral health condition, the general health condition and health-related quality of life (HRQoL) of patients with stroke who are receiving hospital-based rehabilitation. An additional aim is to assess potential longer term oral intervention-related health and HRQoL outcomes.

Detailed Description

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Conditions

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Acute Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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OHI

Patients provided with oral hygiene instruction and electric toothbrush

Group Type EXPERIMENTAL

Oral hygiene intervention

Intervention Type OTHER

Oral health promotion intervention

OHI + CHX mouthrinse

Patients provided with oral hygiene instruction and Corsodyl mouthrinse

Group Type EXPERIMENTAL

Oral hygiene intervention

Intervention Type OTHER

Oral health promotion intervention

OHI + CHX mouthrinse + assisted brushing

Oral hygiene instruction, Corsodyl mouthrinse, and assisted brushing

Group Type EXPERIMENTAL

Oral hygiene intervention

Intervention Type OTHER

Oral health promotion intervention

Interventions

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Oral hygiene intervention

Oral health promotion intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Aged 50 years and over
* Moderate to severe stroke (Barthel Index \>/= 70)
* Admitted to Rehabilitation Unit within 7 days

Exclusion Criteria

* Patients with naso-gastric feeding tube
* Edentulous patients
* Patients with communication difficulties
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Dr. Otto Lok-Tao Lam

Clinical assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Otto LT Lam, BDS, BSc, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

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Tung Wah Hospital

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

References

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Lam OL, McMillan AS, Samaranayake LP, Li LS, McGrath C. Effect of oral hygiene interventions on opportunistic pathogens in patients after stroke. Am J Infect Control. 2013 Feb;41(2):149-54. doi: 10.1016/j.ajic.2012.02.020. Epub 2012 Jul 17.

Reference Type DERIVED
PMID: 22818804 (View on PubMed)

Other Identifiers

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HKCTR-1159

Identifier Type: -

Identifier Source: org_study_id

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