The Effectiveness of Oral Health Promotion on Pneumonia Complicating Stroke

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

Study Overview

• Status: Completed
• Conditions: Stroke; Pneumonia; Oral Hygiene
• Intervention / Treatment: Other: Advanced oral hygiene care programme; Other: Oral hygiene instruction

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.

• Study Type: Interventional
• Enrollment (Actual): 166
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230000
      • The Second People's Hospital of Hefei

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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).	Other: Advanced oral hygiene care programme; Brush teeth with standardized power tooth brush twice a day.; Rinse mouth with chlorhexidine twice a day.; Oral hygiene education
EXPERIMENTAL: Oral hygiene instruction; Patients with stroke will only receive the oral hygiene instruction.	Other: Oral hygiene instruction; Oral hygiene education

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The prevalence of pneumonia complicating stroke	To calculate and compare the incidence of pneumonia between interventional group and control group, to identify whether the intervention approach could reduce the short-term incidence after the baseline.	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The prevalence of pneumonia complicating stroke	To calculate and compare the long-term incidence of pneumonia between interventional group and control group.	1 month, 3 months, 6 months
Metagenomic	To analyze composition and relative abundance of oral microbiome in oral rinse samples.	3 days, 5 days, 7 days, and 1 month, 3 months, 6 months
Plaque Index	0 = no plaque detected with probe; 1 = plaque not visible by unaided eye but detectable with probe; 2 = moderate amount of plaque; 3 = abundance of plaque	1 month, 3 months, 6 months
Gingival Bleeding Index	0 = no bleeding after probing; 1 = presence of bleeding within 10 seconds after probing.	1 month, 3 months, 6 months
the Short Form Health Survey 12 (SF-12)	The SF-12 consists of 12 items covering eight conceptual domains of health: general health (GH), physical functioning (PF), bodily pain (BP), role-physical (RP), mental health (MH), vitality (VT), social functioning (SF), and role-emotional (RE). Four items are reversed for scoring (item no.: 1, 8, 9, and 10). The SF-12 consists of 12 items and each of them has its own physical component summary (PCS) and mental component summary (MCS) regression coefficients. The response to each item will be multiplied by its PCS regression coefficient and added together with the PCS constant to provide Physical Health summary scores (SF-12 PCS). Mental Health summary scores (SF-12 MCS) will be calculated likewise. A higher scores mean a better outcome.	1 month, 3 months, 6 months
the Oral Health Impact Profile 14 (OHIP-14)	0=never, 1=hardly ever, 2=occasionally, 3=fairly often, and 4=very often/all of the time. Summary OHIP-14 score and domain scores will be derived by summating responses to each item (i.e. score 2, 3, and 4). A higher scores mean a worse outcome.	1 month, 3 months, 6 months
the Geriatric Oral Health Assessment Index (GOHAI)	1 = always, 2 = often, 3 = sometimes, 4 = seldom, and 5= never. Summary GOHAI scores will be derived by summating responses to items after reversing the coding of the three positively worded items (swallowing, appearance, and discomfort when eating). A higher scores mean a better outcome.	1 month, 3 months, 6 months

Collaborators and Investigators

• Sponsor: Anhui Medical University
• Investigators: Study Director: Ruoxi Dai, PhD, lecturer

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2018
• Primary Completion (ACTUAL): June 1, 2021
• Study Completion (ACTUAL): June 1, 2021

Study Registration Dates

• First Submitted: October 27, 2018
• First Submitted That Met QC Criteria: September 17, 2019
• First Posted (ACTUAL): September 19, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 21, 2022
• Last Update Submitted That Met QC Criteria: July 20, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Metagenome; Oral opportunistic pathogens; Pneumonia complicating stroke; Oral health promotion
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Stroke; Pneumonia
• Other Study ID Numbers: 81701036

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No