Back to resultsA Randomized Clinical Trial of Oral Health Promotion Interventions Among Patients After Stroke
Primary Purpose
Acute Stroke
Status
Completed
Phase
Phase 4
Locations
Hong Kong
Study Type
Interventional
Intervention
Oral hygiene intervention
Sponsored by
About this trial
This is an interventional treatment trial for Acute Stroke focused on measuring oral health, oral hygiene, bacteria, quality of life, Clinical oral health in patients following acute stroke, Oral opportunistic pathogens in patients following acute stroke, Oral health-related quality of life in patients following acute stroke
Eligibility Criteria
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
Sites / Locations
- Tung Wah Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
OHI
OHI + CHX mouthrinse
OHI + CHX mouthrinse + assisted brushing
Arm Description
Patients provided with oral hygiene instruction and electric toothbrush
Patients provided with oral hygiene instruction and Corsodyl mouthrinse
Oral hygiene instruction, Corsodyl mouthrinse, and assisted brushing
Outcomes
Primary Outcome Measures
Change in plaque scores over course of trial
Secondary Outcome Measures
Change in gingival bleeding scores over course of trial
Change in oral colonization by aerobic and facultatively anaerobic Gram-negative bacilli over course of trial
Change in oral colonization by Staphylococcus aureus over course of trial
Change in oral colonization by yeasts over course of trial
Change in health-related quality of life over course of trial
Change in oral health-related quality of life over course of trial
Full Information
NCT ID
NCT01265043
First Posted
December 7, 2010
Last Updated
October 2, 2021
Sponsor
The University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT01265043
Brief Title
A Randomized Clinical Trial of Oral Health Promotion Interventions Among Patients After Stroke
Official Title
A Randomized Clinical Trial of Oral Health Promotion Interventions Among Patients Following Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Stroke
Keywords
oral health, oral hygiene, bacteria, quality of life, Clinical oral health in patients following acute stroke, Oral opportunistic pathogens in patients following acute stroke, Oral health-related quality of life in patients following acute stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OHI
Arm Type
Experimental
Arm Description
Patients provided with oral hygiene instruction and electric toothbrush
Arm Title
OHI + CHX mouthrinse
Arm Type
Experimental
Arm Description
Patients provided with oral hygiene instruction and Corsodyl mouthrinse
Arm Title
OHI + CHX mouthrinse + assisted brushing
Arm Type
Experimental
Arm Description
Oral hygiene instruction, Corsodyl mouthrinse, and assisted brushing
Intervention Type
Other
Intervention Name(s)
Oral hygiene intervention
Intervention Description
Oral health promotion intervention
Primary Outcome Measure Information:
Title
Change in plaque scores over course of trial
Time Frame
Three week in-hospital rehabilitation period
Secondary Outcome Measure Information:
Title
Change in gingival bleeding scores over course of trial
Time Frame
three week in-hospital rehabilitation period
Title
Change in oral colonization by aerobic and facultatively anaerobic Gram-negative bacilli over course of trial
Time Frame
Three week in-hospital rehabilitation period
Title
Change in oral colonization by Staphylococcus aureus over course of trial
Time Frame
Three week in-hospital rehabilitation period
Title
Change in oral colonization by yeasts over course of trial
Time Frame
Three week in-hospital rehabilitation period
Title
Change in health-related quality of life over course of trial
Time Frame
three week in-hospital rehabilitation period
Title
Change in oral health-related quality of life over course of trial
Time Frame
Three week in-hospital rehabilitation period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Otto LT Lam, BDS, BSc, PhD
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tung Wah Hospital
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Citations:
PubMed Identifier
22818804
Citation
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.
Results Reference
derived
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A Randomized Clinical Trial of Oral Health Promotion Interventions Among Patients After Stroke
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