The Effectiveness of Oral Health Promotion on Pneumonia Complicating Stroke

Stroke Clinical Trial

Official title:

The Effectiveness of Oral Health Promotion on Pneumonia Complicating Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04095780
• Other study ID #: 81701036
• Status: Completed
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: June 1, 2021

Study information

• Verified date: July 2022
• Source: Anhui Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: June 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Oral Hygiene
• Pneumonia
• Stroke

Intervention

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
• Oral hygiene instruction
Oral hygiene education

Locations

Country	Name	City	State
China	The Second People's Hospital of Hefei	Hefei	Anhui

Sponsors (1)

Lead Sponsor	Collaborator
Anhui Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Gingival Bleeding Index	0 = no bleeding after probing; 1 = presence of bleeding within 10 seconds after probing.	1 month, 3 months, 6 months
Secondary	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
Secondary	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
Secondary	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