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Completed

NCT Number: NCT04095780

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Infections Lung Diseases Nervous System Diseases Oral Hygiene Pneumonia Respiratory Tract Diseases Respiratory Tract Infections Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second People's Hospital of Hefei

Hefei, Anhui, 230000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Advanced oral hygiene care programme

Other
  • Brush teeth with standardized power tooth brush twice a day.
  • Rinse mouth with chlorhexidine twice a day.
  • Oral hygiene education

Oral hygiene instruction

Other

Oral hygiene education

Primary outcomes

  1. The prevalence of pneumonia complicating stroke

    Time frame: 1 week

    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 outcomes

  1. The prevalence of pneumonia complicating stroke

    Time frame: 1 month, 3 months, 6 months

    To calculate and compare the long-term incidence of pneumonia between interventional group and control group.

  2. Metagenomic

    Time frame: 3 days, 5 days, 7 days, and 1 month, 3 months, 6 months

    To analyze composition and relative abundance of oral microbiome in oral rinse samples.

  3. Plaque Index

    Time frame: 1 month, 3 months, 6 months

    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

  4. Gingival Bleeding Index

    Time frame: 1 month, 3 months, 6 months

    0 = no bleeding after probing; 1 = presence of bleeding within 10 seconds after probing.

  5. the Short Form Health Survey 12 (SF-12)

    Time frame: 1 month, 3 months, 6 months

    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.

  6. the Oral Health Impact Profile 14 (OHIP-14)

    Time frame: 1 month, 3 months, 6 months

    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.

  7. the Geriatric Oral Health Assessment Index (GOHAI)

    Time frame: 1 month, 3 months, 6 months

    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.

Sponsors and collaborators

Lead sponsor

Anhui Medical University

Other

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Sep 19, 2019
Registry last updated
Jul 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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