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

Phase 4

Completed

• Conditions: Acute Stroke
• Interventions: Other: Oral hygiene intervention

• Registration Number: NCT01265043
• Lead Sponsor: The University of Hong Kong

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2010-12-07
• Study First Submitted QC: 2010-12-21
• Study First Posted: 2010-12-22
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-02
• Last Update Posted: 2021-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OHI + CHX mouthrinse + assisted brushing	Oral hygiene intervention	Oral hygiene instruction, Corsodyl mouthrinse, and assisted brushing
OHI	Oral hygiene intervention	Patients provided with oral hygiene instruction and electric toothbrush
OHI + CHX mouthrinse	Oral hygiene intervention	Patients provided with oral hygiene instruction and Corsodyl mouthrinse

Primary Outcome Measures

Name	Time	Method
Change in plaque scores over course of trial	Three week in-hospital rehabilitation period

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Tung Wah Hospital; 🇭🇰 Hong Kong, Hong Kong