NCT04095780

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
166

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Nov 2018

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
11 months until next milestone

First Posted

Study publicly available on registry

September 19, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

July 21, 2022

Status Verified

July 1, 2022

Enrollment Period

2.6 years

First QC Date

October 27, 2018

Last Update Submit

July 20, 2022

Conditions

StrokePneumoniaOral Hygiene

Keywords

Oral opportunistic pathogensOral health promotionPneumonia complicating strokeMetagenome

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • The prevalence of pneumonia complicating stroke

    1 month, 3 months, 6 months

  • Metagenomic

    3 days, 5 days, 7 days, and 1 month, 3 months, 6 months

  • Plaque Index

    1 month, 3 months, 6 months

  • Gingival Bleeding Index

    1 month, 3 months, 6 months

  • the Short Form Health Survey 12 (SF-12)

    1 month, 3 months, 6 months

  • +2 more secondary outcomes

Study Arms (2)

Advanced oral hygiene care programme

EXPERIMENTAL

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

Oral hygiene instruction

EXPERIMENTAL

Patients with stroke will only receive the oral hygiene instruction.

Other: Oral hygiene instruction

Interventions

Advanced oral hygiene care programmeOTHER

1. Brush teeth with standardized power tooth brush twice a day. 2. Rinse mouth with chlorhexidine twice a day. 3. Oral hygiene education

Advanced oral hygiene care programme
Oral hygiene instructionOTHER

Oral hygiene education

Oral hygiene instruction

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second People's Hospital of Hefei

Hefei, Anhui, 230000, China

Location

Related Publications (1)

  • 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.

    PMID: 32650814DERIVED

MeSH Terms

Conditions

StrokePneumonia

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesRespiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Ruoxi Dai, PhD

    Lecturer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 27, 2018

First Posted

September 19, 2019

Study Start

November 1, 2018

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

July 21, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)