The Effectiveness of Oral Health Promotion on Pneumonia Complicating Stroke

NCT ID: NCT04095780

Last Updated: 2022-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 166 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-01
• Study Completion Date: 2021-06-01

Brief Summary

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

Detailed 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.

Conditions

Stroke; Pneumonia; Oral Hygiene

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Advanced oral hygiene care programme

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).

Group Type: EXPERIMENTAL

Advanced oral hygiene care programme

Intervention Type: OTHER

1. Brush teeth with standardized power tooth brush twice a day.

2. Rinse mouth with chlorhexidine twice a day.

3. Oral hygiene education

Oral hygiene instruction

Patients with stroke will only receive the oral hygiene instruction.

Group Type: EXPERIMENTAL

Oral hygiene instruction

Intervention Type: OTHER

Oral hygiene education

Interventions

Advanced oral hygiene care programme

1. Brush teeth with standardized power tooth brush twice a day.

2. Rinse mouth with chlorhexidine twice a day.

3. Oral hygiene education

Intervention Type: OTHER

Oral hygiene instruction

Oral hygiene education

Intervention Type: OTHER

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anhui Medical University

OTHER

Sponsor Role: lead

Responsible Party

Ya Zhang

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ruoxi Dai, PhD

Role: STUDY_DIRECTOR

Lecturer

Locations

The Second People's Hospital of Hefei

Hefei, Anhui, China

Countries

China

References

Wu J, Dai Y, Lo ECM, Qi Y, Zhang Y, Li QL, Dai R. Using metagenomic analysis to assess the effectiveness of oral health promotion interventions in reducing risk for pneumonia among patients with stroke in acute phase: study protocol for a randomized controlled trial. Trials. 2020 Jul 10;21(1):634. doi: 10.1186/s13063-020-04528-3.

Reference Type: DERIVED

PMID: 32650814 (View on PubMed)

Other Identifiers

81701036

Identifier Type: -

Identifier Source: org_study_id