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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01265043
Enrollment
102
Registered
2010-12-22
Start date
2008-07-31
Completion date
2011-05-31
Last updated
2021-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

Oral health promotion intervention

Sponsors

The University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Change in plaque scores over course of trialThree week in-hospital rehabilitation period

Secondary

MeasureTime frame
Change in oral colonization by aerobic and facultatively anaerobic Gram-negative bacilli over course of trialThree week in-hospital rehabilitation period
Change in oral colonization by Staphylococcus aureus over course of trialThree week in-hospital rehabilitation period
Change in gingival bleeding scores over course of trialthree week in-hospital rehabilitation period
Change in health-related quality of life over course of trialthree week in-hospital rehabilitation period
Change in oral health-related quality of life over course of trialThree week in-hospital rehabilitation period
Change in oral colonization by yeasts over course of trialThree week in-hospital rehabilitation period

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026