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

Completed

Phase 4 Results N/A

Trial Description

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.

Conditions

Interventions

  • Oral hygiene intervention Other
    Intervention Desc: Oral health promotion intervention
    ARM 1: Kind: Experimental
    Label: OHI
    Description: Patients provided with oral hygiene instruction and electric toothbrush
    ARM 2: Kind: Experimental
    Label: OHI + CHX mouthrinse
    Description: Patients provided with oral hygiene instruction and Corsodyl mouthrinse
    ARM 3: Kind: Experimental
    Label: OHI + CHX mouthrinse + assisted brushing
    Description: Oral hygiene instruction, Corsodyl mouthrinse, and assisted brushing

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Change in plaque scores over course of trial Three week in-hospital rehabilitation period No
Secondary Change in gingival bleeding scores over course of trial three week in-hospital rehabilitation period No
Secondary Change in oral colonization by aerobic and facultatively anaerobic Gram-negative bacilli over course of trial Three week in-hospital rehabilitation period No
Secondary Change in oral colonization by Staphylococcus aureus over course of trial Three week in-hospital rehabilitation period No
Secondary Change in oral colonization by yeasts over course of trial Three week in-hospital rehabilitation period No
Secondary Change in health-related quality of life over course of trial three week in-hospital rehabilitation period No
Secondary Change in oral health-related quality of life over course of trial Three week in-hospital rehabilitation period No

Sponsors