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Clinical Trials/NCT01265043
NCT01265043
Completed
Phase 4

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

The University of Hong Kong1 site in 1 country102 target enrollmentJuly 2008
ConditionsAcute Stroke

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Acute Stroke
Sponsor
The University of Hong Kong
Enrollment
102
Locations
1
Primary Endpoint
Change in plaque scores over course of trial
Status
Completed
Last Updated
4 years ago

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.

Registry
clinicaltrials.gov
Start Date
July 2008
End Date
May 2011
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Otto Lok-Tao Lam

Clinical assistant professor

The University of Hong Kong

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

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)

Study Sites (1)

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