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

The University of Hong Kong (HKU)

Status and phase: Completed; Phase 4

Conditions: Acute Stroke

Treatments: Other: Oral hygiene intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT01265043

HKCTR-1159

Details and patient eligibility

About

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.

Enrollment: 102 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

102 participants in 3 patient groups

OHI

Experimental group

Description:

Patients provided with oral hygiene instruction and electric toothbrush

Treatment:

Other: Oral hygiene intervention

OHI + CHX mouthrinse

Experimental group

Description:

Patients provided with oral hygiene instruction and Corsodyl mouthrinse

Treatment:

Other: Oral hygiene intervention

OHI + CHX mouthrinse + assisted brushing

Experimental group

Description:

Oral hygiene instruction, Corsodyl mouthrinse, and assisted brushing

Treatment:

Other: Oral hygiene intervention