search
Back to results

The Effectiveness of Oral Health Promotion on Pneumonia Complicating Stroke

Primary Purpose

Stroke, Pneumonia, Oral Hygiene

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Advanced oral hygiene care programme
Oral hygiene instruction
Sponsored by
Anhui Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Oral opportunistic pathogens, Oral health promotion, Pneumonia complicating stroke, Metagenome

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • The Second People's Hospital of Hefei

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Advanced oral hygiene care programme

Oral hygiene instruction

Arm 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).

Patients with stroke will only receive the oral hygiene instruction.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The prevalence of pneumonia complicating stroke
To calculate and compare the long-term incidence of pneumonia between interventional group and control group.
Metagenomic
To analyze composition and relative abundance of oral microbiome in oral rinse samples.
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
Gingival Bleeding Index
0 = no bleeding after probing; 1 = presence of bleeding within 10 seconds after probing.
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.
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.
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.

Full Information

First Posted
October 27, 2018
Last Updated
July 20, 2022
Sponsor
Anhui Medical University
search

1. Study Identification

Unique Protocol Identification Number
NCT04095780
Brief Title
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

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
June 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Anhui Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Pneumonia, Oral Hygiene
Keywords
Oral opportunistic pathogens, Oral health promotion, Pneumonia complicating stroke, Metagenome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
166 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Advanced oral hygiene care programme
Arm Type
Experimental
Arm 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).
Arm Title
Oral hygiene instruction
Arm Type
Experimental
Arm Description
Patients with stroke will only receive the oral hygiene instruction.
Intervention Type
Other
Intervention Name(s)
Advanced oral hygiene care programme
Intervention Description
Brush teeth with standardized power tooth brush twice a day. Rinse mouth with chlorhexidine twice a day. Oral hygiene education
Intervention Type
Other
Intervention Name(s)
Oral hygiene instruction
Intervention Description
Oral hygiene education
Primary Outcome Measure Information:
Title
The prevalence of pneumonia complicating stroke
Description
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.
Time Frame
1 week
Secondary Outcome Measure Information:
Title
The prevalence of pneumonia complicating stroke
Description
To calculate and compare the long-term incidence of pneumonia between interventional group and control group.
Time Frame
1 month, 3 months, 6 months
Title
Metagenomic
Description
To analyze composition and relative abundance of oral microbiome in oral rinse samples.
Time Frame
3 days, 5 days, 7 days, and 1 month, 3 months, 6 months
Title
Plaque Index
Description
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
Time Frame
1 month, 3 months, 6 months
Title
Gingival Bleeding Index
Description
0 = no bleeding after probing; 1 = presence of bleeding within 10 seconds after probing.
Time Frame
1 month, 3 months, 6 months
Title
the Short Form Health Survey 12 (SF-12)
Description
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.
Time Frame
1 month, 3 months, 6 months
Title
the Oral Health Impact Profile 14 (OHIP-14)
Description
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.
Time Frame
1 month, 3 months, 6 months
Title
the Geriatric Oral Health Assessment Index (GOHAI)
Description
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.
Time Frame
1 month, 3 months, 6 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruoxi Dai, PhD
Organizational Affiliation
Lecturer
Official's Role
Study Director
Facility Information:
Facility Name
The Second People's Hospital of Hefei
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32650814
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.
Results Reference
derived

Learn more about this trial

The Effectiveness of Oral Health Promotion on Pneumonia Complicating Stroke

We'll reach out to this number within 24 hrs