- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01265043
A Randomized Clinical Trial of Oral Health Promotion Interventions Among Patients After Stroke
October 2, 2021 updated by: Dr. Otto Lok-Tao Lam, The University of Hong Kong
A Randomized Clinical Trial of Oral Health Promotion Interventions Among Patients Following Stroke
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
102
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Hong Kong, Hong Kong
- Tung Wah Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: OHI
Patients provided with oral hygiene instruction and electric toothbrush
|
Oral health promotion intervention
|
EXPERIMENTAL: OHI + CHX mouthrinse
Patients provided with oral hygiene instruction and Corsodyl mouthrinse
|
Oral health promotion intervention
|
EXPERIMENTAL: OHI + CHX mouthrinse + assisted brushing
Oral hygiene instruction, Corsodyl mouthrinse, and assisted brushing
|
Oral health promotion intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in plaque scores over course of trial
Time Frame: Three week in-hospital rehabilitation period
|
Three week in-hospital rehabilitation period
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in gingival bleeding scores over course of trial
Time Frame: three week in-hospital rehabilitation period
|
three week in-hospital rehabilitation period
|
Change in oral colonization by aerobic and facultatively anaerobic Gram-negative bacilli over course of trial
Time Frame: Three week in-hospital rehabilitation period
|
Three week in-hospital rehabilitation period
|
Change in oral colonization by Staphylococcus aureus over course of trial
Time Frame: Three week in-hospital rehabilitation period
|
Three week in-hospital rehabilitation period
|
Change in oral colonization by yeasts over course of trial
Time Frame: Three week in-hospital rehabilitation period
|
Three week in-hospital rehabilitation period
|
Change in health-related quality of life over course of trial
Time Frame: three week in-hospital rehabilitation period
|
three week in-hospital rehabilitation period
|
Change in oral health-related quality of life over course of trial
Time Frame: Three week in-hospital rehabilitation period
|
Three week in-hospital rehabilitation period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Otto LT Lam, BDS, BSc, PhD, The University of Hong Kong
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2008
Primary Completion (ACTUAL)
May 1, 2011
Study Completion (ACTUAL)
May 1, 2011
Study Registration Dates
First Submitted
December 7, 2010
First Submitted That Met QC Criteria
December 21, 2010
First Posted (ESTIMATE)
December 22, 2010
Study Record Updates
Last Update Posted (ACTUAL)
October 8, 2021
Last Update Submitted That Met QC Criteria
October 2, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HKCTR-1159
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acute Stroke
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University of CalgaryThe George Institute for Global Health, AustraliaNot yet recruitingAcute Ischemic Stroke AIS | Stroke, Acute, Stroke Ischemic | Stroke AcuteCanada, Australia
-
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-
National Taiwan University HospitalCompleted
-
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Clinical Trials on Oral hygiene intervention
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-
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-
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-
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