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

Acute Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01265043
• Other study ID #: HKCTR-1159
• Status: Completed
• Phase: Phase 4
• Start date: July 2008
• Est. completion date: May 2011

Study information

• Verified date: October 2021
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Stroke
• Stroke

Intervention

Other:
• Oral hygiene intervention
Oral health promotion intervention

Locations

Country	Name	City	State
Hong Kong	Tung Wah Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in plaque scores over course of trial		Three week in-hospital rehabilitation period
Secondary	Change in gingival bleeding scores over course of trial		three week in-hospital rehabilitation period
Secondary	Change in oral colonization by aerobic and facultatively anaerobic Gram-negative bacilli over course of trial		Three week in-hospital rehabilitation period
Secondary	Change in oral colonization by Staphylococcus aureus over course of trial		Three week in-hospital rehabilitation period
Secondary	Change in oral colonization by yeasts over course of trial		Three week in-hospital rehabilitation period
Secondary	Change in health-related quality of life over course of trial		three week in-hospital rehabilitation period
Secondary	Change in oral health-related quality of life over course of trial		Three week in-hospital rehabilitation period