Clinical trial NCT04095780: The Effectiveness of Oral Health Promotion on Pneumonia Complicating Stroke
Official title: The Effectiveness of Oral Health Promotion on Pneumonia Complicating Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Pneumonia
Oral Hygiene
Keywords: Oral opportunistic pathogens
Oral health promotion
Pneumonia complicating stroke
Metagenome
Lead sponsor: Anhui Medical University
Sponsor class: OTHER
First posted: 2019-09-19
Enrollment: 166
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The prevalence of pneumonia complicating stroke
timeFrame: 1 week
Secondary outcomes:
measure: The prevalence of pneumonia complicating stroke
timeFrame: 1 month, 3 months, 6 months
measure: Metagenomic
timeFrame: 3 days, 5 days, 7 days, and 1 month, 3 months, 6 months
measure: Plaque Index
timeFrame: 1 month, 3 months, 6 months
measure: Gingival Bleeding Index
timeFrame: 1 month, 3 months, 6 months
measure: the Short Form Health Survey 12 (SF-12)
timeFrame: 1 month, 3 months, 6 months
measure: the Oral Health Impact Profile 14 (OHIP-14)
timeFrame: 1 month, 3 months, 6 months
measure: the Geriatric Oral Health Assessment Index (GOHAI)
timeFrame: 1 month, 3 months, 6 months
Other outcomes:
Locations:
city: Hefei
country: China
facility: The Second People's Hospital of Hefei
state: Anhui
Study officials:
affiliation: Lecturer
name: Ruoxi Dai, PhD
role: STUDY_DIRECTOR
References:
citation: 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.