A Randomized Clinical Trial of Oral Health Promotion Interventions Among Patients Following Stroke
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- The University of Hong Kong
- Enrollment
- 102
- Locations
- 1
- Primary Endpoint
- Change in plaque scores over course of trial
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
OHI
Patients provided with oral hygiene instruction and electric toothbrush
Intervention: Oral hygiene intervention (Other)
OHI + CHX mouthrinse
Patients provided with oral hygiene instruction and Corsodyl mouthrinse
Intervention: Oral hygiene intervention (Other)
OHI + CHX mouthrinse + assisted brushing
Oral hygiene instruction, Corsodyl mouthrinse, and assisted brushing
Intervention: Oral hygiene intervention (Other)
Outcomes
Primary Outcomes
Change in plaque scores over course of trial
Time Frame: Three week in-hospital rehabilitation period
Secondary Outcomes
- Change in oral health-related quality of life over course of trial(Three week in-hospital rehabilitation period)
- Change in gingival bleeding scores over course of trial(three week in-hospital rehabilitation period)
- Change in oral colonization by Staphylococcus aureus over course of trial(Three week in-hospital rehabilitation period)
- Change in oral colonization by yeasts over course of trial(Three week in-hospital rehabilitation period)
- Change in oral colonization by aerobic and facultatively anaerobic Gram-negative bacilli over course of trial(Three week in-hospital rehabilitation period)
- Change in health-related quality of life over course of trial(three week in-hospital rehabilitation period)
Investigators
Dr. Otto Lok-Tao Lam
Clinical assistant professor
The University of Hong Kong