The Effectiveness of Oral Health Promotion on Pneumonia Complicating Stroke

Anhui Medical University

Status: Completed

Conditions: Stroke; Oral Hygiene; Pneumonia

Treatments: Other: Advanced oral hygiene care programme; Other: Oral hygiene instruction

Study type: Interventional

Funder types: Other

Identifiers

NCT04095780

81701036

Details and patient eligibility

About

To investigate the evidence for the integration of oral health promotion as part of interdisciplinary stroke rehabilitation.

Full description

Pneumonia complicating stroke is very difficult to manage and has a very poor prognosis, leading to a significantly higher risk of death. Oral opportunistic pathogens have been reported to be associated with the incidence of pneumonia among non-stroke immunocompromised subjects. Preliminary studies found that patients with stroke had higher carriage rates of oral opportunistic pathogens than healthy subjects. Therefore, investigators hypothesize that pneumonia complicating stroke is associated with oral opportunistic pathogens, and oral health promotion interventions may reduce the incidence of pneumonia complicating stroke via its effects on the species and relative abundance of oral opportunistic pathogens. In order to prove this, investigators need to (1) firstly conduct a randomized controlled trial to confirm whether oral health promotion is able to reduce the levels of plaque, and the incidence of pneumonia complicating stroke at clinical level; (2) secondly employ metagenomics analysis to compare oral rinse samples and respiratory samples, and to identify pneumonia-associated "oral opportunistic pathogens group"; (3) finally elucidate how oral health promotion influences the species and relative abundance of oral opportunistic pathogens. This proposed study will provide evidence for the integration of oral health promotion as part of interdisciplinary stroke rehabilitation.

Enrollment: 166 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• having onset of stroke within 3 days and free of any post-stroke complication
• having moderate to severe functional disability- Barthel Index (BI) scores of <70
• being conscious and respiring voluntarily without ventilator
• not having any lung disease and lower respiratory infection
• not have an indwelling naso-gastric feeding tubes
• having dysphagia as showed by GUSS test (The Gugging Swallowing Screen, GUSS)
• having normal cognitive ability or mild impairment- Mini Mental State Examination (MMSE) >18
• having ability to follow instruction (as an assessment of compliance of oral health intervention)
• not having systemic administration of antibiotics
• not being edentulous

Exclusion criteria

• mild disability (Barthel Index > 70)
• having normal swallowing function
• edentulous
• having an indwelling naso-gastric feeding tubes
• having communication disorders, unable to cooperate with family caregivers for oral health promotion

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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166 participants in 2 patient groups

Advanced oral hygiene care programme

Experimental group

Description:

Patients with stroke will receive the advanced oral hygiene care programme (AOHCP) comprising powered tooth brushing and mouth rinsing with chlorhexidine (with a supply of standardized power tooth brushes, mouth rinse, tooth paste and oral hygiene instruction).

Treatment:

Other: Advanced oral hygiene care programme

Oral hygiene instruction

Experimental group

Description:

Patients with stroke will only receive the oral hygiene instruction.

Treatment:

Other: Oral hygiene instruction