StrokeNCT04095780
The Effectiveness of Oral Health Promotion on Pneumonia Complicating Stroke
A study testing Advanced oral hygiene care programme and Oral hygiene instruction in people with Stroke and Pneumonia, run by Anhui Medical University at 1 site in China.
Trial summary
To investigate the evidence for the integration of oral health promotion as part of interdisciplinary stroke rehabilitation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke, Pneumonia, Oral Hygiene
- What is being tested?
- Advanced oral hygiene care programme and Oral hygiene instruction
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2018to 1 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
To investigate the evidence for the integration of oral health promotion as part of interdisciplinary stroke rehabilitation.
Read the 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.
- Conditions
- Stroke, Pneumonia, Oral Hygiene
- Being tested
- Advanced oral hygiene care programme, Oral hygiene instruction
- Keywords
- Oral opportunistic pathogens, Oral health promotion, Pneumonia complicating stroke, Metagenome
- Medical subject headings
- Stroke, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advanced oral hygiene care programmeOther
- Brush teeth with standardized power tooth brush twice a day.
- Rinse mouth with chlorhexidine twice a day.
- Oral hygiene education
Oral hygiene instructionOther
Oral hygiene education
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Advanced oral hygiene care programme |
| Oral hygiene instruction | Experimental | Patients with stroke will only receive the oral hygiene instruction. Receives: Other: Oral hygiene instruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week
Secondary outcomes (7)
The prevalence of pneumonia complicating stroke
To calculate and compare the long-term incidence of pneumonia between interventional group and control group.
Measured: 1 month, 3 months, 6 months
Metagenomic
To analyze composition and relative abundance of oral microbiome in oral rinse samples.
Measured: 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
Measured: 1 month, 3 months, 6 months
Gingival Bleeding Index
0 = no bleeding after probing; 1 = presence of bleeding within 10 seconds after probing.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 month, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start1 Nov 2018
- Primary completion1 Jun 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ya Zhang, Anhui Medical University
- Investigators
- Ruoxi Dai, PhD, Study director, Lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04095780
- Sponsor's protocol ID
- 81701036
- Status last verified
- Jul 2022
- First submitted
- 27 Oct 2018
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32650814
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Oral Health Promotion on Pneumonia Complicating Stroke
- ClinicalTrials.gov ID
- NCT04095780
- Acronym / sponsor ID
- 81701036
- Conditions
- Stroke, Pneumonia, Oral Hygiene
- Keywords
- Oral opportunistic pathogens, Oral health promotion, Pneumonia complicating stroke, Metagenome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Anhui Medical UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 19 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Advanced oral hygiene care programme | Experimental | Other: Advanced oral hygiene care programmePatients 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). |
| Oral hygiene instruction | Experimental | Other: Oral hygiene instructionPatients with stroke will only receive the oral hygiene instruction. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Advanced oral hygiene care programme1. Brush teeth with standardized power tooth brush twice a day. 2. Rinse mouth with chlorhexidine twice a day. 3. Oral hygiene education | Other | Advanced oral hygiene care programme |
| Oral hygiene instructionOral hygiene education | Other | Oral hygiene instruction |
Primary outcome
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.
7 secondary outcomes
The prevalence of pneumonia complicating stroke
Time frame: 1 month, 3 months, 6 months
Metagenomic
Time frame: 3 days, 5 days, 7 days, and 1 month, 3 months, 6 months
Plaque Index
Time frame: 1 month, 3 months, 6 months
Gingival Bleeding Index
Time frame: 1 month, 3 months, 6 months
the Short Form Health Survey 12 (SF-12)
Time frame: 1 month, 3 months, 6 months
the Oral Health Impact Profile 14 (OHIP-14)
Time frame: 1 month, 3 months, 6 months
the Geriatric Oral Health Assessment Index (GOHAI)
Time frame: 1 month, 3 months, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
- Derived from this study: PubMed 32650814Wu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruoxi Dai, PhD study director
Lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Advanced oral hygiene care programme and Oral hygiene instruction in people with Stroke and Pneumonia, run by Anhui Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prevalence of pneumonia complicating stroke (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04095780, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2022.