StrokeOH-STROKENCT07382089
Effect of Oral Hygiene Care on Prevention of Aspiration Pneumonia Among Hospitalized Stroke Patients
A study testing Oral hygiene care bundle in people with Stroke and Aspiration Pneumonia, run by Addis Ababa University at 1 site in Ethiopia.
Trial summary
Aspiration pneumonia is a common and serious complication among hospitalized patients with stroke. Poor oral hygiene can increase the risk of aspiration pneumonia by promoting bacterial colonization of the oral cavity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Aspiration Pneumonia
- What is being tested?
- Oral hygiene care bundle
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEthiopia
- Study dates
- 1 May 2023to 30 Jan 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older
- Hospitalized patients with a confirmed diagnosis of acute stroke (ischemic or hemorrhagic)
- Admission to the stroke unit or medical ward during the study period
- Ability to receive oral care as part of routine nursing care
Who cannot join
- Patients with active pneumonia at the time of hospital admission
- Patients who were intubated or mechanically ventilated at admission
- Patients with facial or oral conditions precluding oral hygiene care
- Patients discharged or deceased within 24 hours of admission
Trial locations and contacts
1 site in 1 country.
Ethiopia1 site
Tikur Anbessa Specialized Hospital, Addis Ababa University
Addis Ababa, Addis Ababa, 26901
About this study
Official title: Effect of Oral Hygiene Care on Aspiration Pneumonia Among Hospitalized Stroke Patients: A Quasi-Experimental Study With Historical Controls
Aspiration pneumonia is a common and serious complication among hospitalized patients with stroke. Poor oral hygiene can increase the risk of aspiration pneumonia by promoting bacterial colonization of the oral cavity. This study evaluated whether implementing a structured oral hygiene care protocol during hospitalization could reduce the incidence of aspiration pneumonia among stroke patients. In this non-randomized, quasi-experimental study, patients admitted after implementation of an oral hygiene care protocol received structured oral care delivered by trained nursing staff, while patients admitted prior to implementation served as historical controls and received standard care. The primary outcome was the occurrence of aspiration pneumonia during hospitalization. The findings of this study aim to inform simple, low-cost preventive strategies that may improve clinical outcomes for hospitalized stroke patients, particularly in resource-limited settings.
Read the detailed description
This study is a quasi-experimental, non-randomized interventional study with parallel assignment using historical controls, conducted among hospitalized adult stroke patients at a tertiary care hospital. The study evaluated the effect of implementing a structured oral hygiene care protocol on the incidence of aspiration pneumonia during hospitalization. Patients admitted prior to implementation of the oral hygiene care protocol constituted the historical control group and received standard oral care practices. Patients admitted after implementation received a structured oral hygiene care bundle delivered by trained nursing staff as part of routine inpatient care. The oral hygiene intervention included regular oral cavity cleaning and toothbrushing according to a predefined protocol. The primary outcome was aspiration pneumonia diagnosed during hospitalization based on clinical features and radiologic findings. Secondary outcomes included in-hospital clinical outcomes as defined in the study protocol. Ethical approval was obtained from the Institutional Review Board of Tikur Anbessa Specialized Hospital, and informed consent was obtained from participants or their legal representatives, with appropriate waivers applied for retrospective data where applicable. This study was designed to assess the feasibility and effectiveness of a low-cost, preventive intervention that may reduce aspiration-related complications among stroke patients, particularly in resource-constrained healthcare settings.
- Conditions
- Stroke, Aspiration Pneumonia
- Being tested
- Oral hygiene care bundle
- Keywords
- Oral hygiene, Aspiration pneumonia prevention, Stroke patients, Dysphagia, Hospital-acquired pneumonia
- Medical subject headings
- Stroke, Pneumonia, Aspiration, Deglutition Disorders, Healthcare-Associated Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral hygiene care bundleBehavioural
Also called Oral hygiene
A structured oral hygiene care protocol including regular oral cavity cleaning and toothbrushing during hospitalization.
| Study group | Role | What they receive |
|---|---|---|
| Oral Hygiene Care Intervention | Experimental | Patients admitted after implementation of a structured oral hygiene care protocol delivered by trained nursing staff during hospitalization. Receives: Behavioral: Oral hygiene care bundle |
| Historical Control Group | No intervention | Patients admitted prior to implementation of the oral hygiene care protocol who received standard oral care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Aspiration Pneumonia
Aspiration pneumonia diagnosed during hospital admission, based on clinical features (fever, cough, purulent sputum), radiologic evidence of new pulmonary infiltrates, and treating physician documentation.
Measured: From baseline (hospital admission) through hospital discharge, up to 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start1 May 2023
- Primary completion30 Jan 2024
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a non-randomized, parallel assignment study using historical controls. Patients admitted after implementation of the oral hygiene care protocol received the intervention, while patients admitted prior to implementation served as the control group.
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Addis Ababa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Surafel Tilahun Maru, Addis Ababa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07382089
- Sponsor's protocol ID
- TASH_OH_STROKE_AP1
- Acronym
- OH-STROKE
- Status last verified
- Jan 2026
- First submitted
- 26 Jan 2026
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen HJ, Chen JL, Chen CY, Lee M, Chang WH, Huang TT. Effect of an Oral Health Programme on Oral Health, Oral Intake, and Nutrition in Patients with Stroke and Dysphagia in Taiwan: A Randomised Controlled Trial. Int J Environ Res Public Health. 2019 Jun 24;16(12):2228. doi: 10.3390/ijerph16122228.
PubMed 31238591O'Malley L, Powell R, Hulme S, Lievesley M, Westoby W, Zadik J, Bowen A, Brocklehurst P, Smith CJ. A qualitative exploration of oral health care among stroke survivors living in the community. Health Expect. 2020 Oct;23(5):1086-1095. doi: 10.1111/hex.13074. Epub 2020 Jun 19.
PubMed 32558061Dai R, Lam OLT, Lo ECM, Li LSW, McGrath C. A randomized clinical trial of oral hygiene care programmes during stroke rehabilitation. J Dent. 2017 Jun;61:48-54. doi: 10.1016/j.jdent.2017.04.001. Epub 2017 Apr 6.
PubMed 28392215Kim EK, Park EY, Sa Gong JW, Jang SH, Choi YH, Lee HK. Lasting effect of an oral hygiene care program for patients with stroke during in-hospital rehabilitation: a randomized single-center clinical trial. Disabil Rehabil. 2017 Nov;39(22):2324-2329. doi: 10.1080/09638288.2016.1226970. Epub 2016 Sep 15.
PubMed 27628624Chan EY, Lee YK, Poh TH, Ng IH, Prabhakaran L. Translating evidence into nursing practice: oral hygiene for care dependent adults. Int J Evid Based Healthc. 2011 Jun;9(2):172-83. doi: 10.1111/j.1744-1609.2011.00214.x.
PubMed 21599846Cardoso AF, Ribeiro LE, Santos T, Pinto M, Rocha C, Magalhaes J, Augusto B, Santos D, Duque FM, Fernandes BL, Sousa RC, Silva R, Ventura F, Fernandes AM, Cardoso D, Rodrigues R. Oral Hygiene in Patients with Stroke: A Best Practice Implementation Project Protocol. Nurs Rep. 2023 Jan 31;13(1):148-156. doi: 10.3390/nursrep13010016.
PubMed 36810267
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oral Hygiene Care on Aspiration Pneumonia Among Hospitalized Stroke Patients: A Quasi-Experimental Study With Historical Controls
- ClinicalTrials.gov ID
- NCT07382089
- Acronym / sponsor ID
- OH-STROKE / TASH_OH_STROKE_AP1
- Conditions
- Stroke, Aspiration Pneumonia
- Keywords
- Oral hygiene, Aspiration pneumonia prevention, Stroke patients, Dysphagia, Hospital-acquired pneumonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Addis Ababa UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 2 Feb 2026 (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.
Aspiration pneumonia is a common and serious complication among hospitalized patients with stroke. Poor oral hygiene can increase the risk of aspiration pneumonia by promoting bacterial colonization of the oral cavity. This study evaluated whether implementing a structured oral hygiene care protocol during hospitalization could reduce the incidence of aspiration pneumonia among stroke patients. In this non-randomized, quasi-experimental study, patients admitted after implementation of an oral hygiene care protocol received structured oral care delivered by trained nursing staff, while patients admitted prior to implementation served as historical controls and received standard care. The primary outcome was the occurrence of aspiration pneumonia during hospitalization. The findings of this study aim to inform simple, low-cost preventive strategies that may improve clinical outcomes for hospitalized stroke patients, particularly in resource-limited settings.
Detailed description
This study is a quasi-experimental, non-randomized interventional study with parallel assignment using historical controls, conducted among hospitalized adult stroke patients at a tertiary care hospital. The study evaluated the effect of implementing a structured oral hygiene care protocol on the incidence of aspiration pneumonia during hospitalization. Patients admitted prior to implementation of the oral hygiene care protocol constituted the historical control group and received standard oral care practices. Patients admitted after implementation received a structured oral hygiene care bundle delivered by trained nursing staff as part of routine inpatient care. The oral hygiene intervention included regular oral cavity cleaning and toothbrushing according to a predefined protocol. The primary outcome was aspiration pneumonia diagnosed during hospitalization based on clinical features and radiologic findings. Secondary outcomes included in-hospital clinical outcomes as defined in the study protocol. Ethical approval was obtained from the Institutional Review Board of Tikur Anbessa Specialized Hospital, and informed consent was obtained from participants or their legal representatives, with appropriate waivers applied for retrospective data where applicable. This study was designed to assess the feasibility and effectiveness of a low-cost, preventive intervention that may reduce aspiration-related complications among stroke patients, particularly in resource-constrained healthcare settings.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a non-randomized, parallel assignment study using historical controls. Patients admitted after implementation of the oral hygiene care protocol received the intervention, while patients admitted prior to implementation served as the control group.
| Arm | Type | Receives |
|---|---|---|
| Oral Hygiene Care Intervention | Experimental | Behavioral: Oral hygiene care bundlePatients admitted after implementation of a structured oral hygiene care protocol delivered by trained nursing staff during hospitalization. |
| Historical Control Group | No intervention | –Patients admitted prior to implementation of the oral hygiene care protocol who received standard oral care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 years or older
- Hospitalized patients with a confirmed diagnosis of acute stroke (ischemic or hemorrhagic)
- Admission to the stroke unit or medical ward during the study period
- Ability to receive oral care as part of routine nursing care
Key exclusion criteria (4 listed)
- Patients with active pneumonia at the time of hospital admission
- Patients who were intubated or mechanically ventilated at admission
- Patients with facial or oral conditions precluding oral hygiene care
- Patients discharged or deceased within 24 hours of admission
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 |
|---|---|---|
| Oral hygiene care bundleAlso: Oral hygieneA structured oral hygiene care protocol including regular oral cavity cleaning and toothbrushing during hospitalization. | Behavioural | Oral Hygiene Care Intervention |
Primary outcome
Incidence of Aspiration Pneumonia
Time frame: From baseline (hospital admission) through hospital discharge, up to 21 days
Aspiration pneumonia diagnosed during hospital admission, based on clinical features (fever, cough, purulent sputum), radiologic evidence of new pulmonary infiltrates, and treating physician documentation.
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 2 Feb 2026.
- Results publication: PubMed 31238591Chen HJ, Chen JL, Chen CY, Lee M, Chang WH, Huang TT. Effect of an Oral Health Programme on Oral Health, Oral Intake, and Nutrition in Patients with Stroke and Dysphagia in Taiwan: A Randomised Controlled Trial. Int J Environ Res Public Health. 2019 Jun 24;16(12):2228. doi: 10.3390/ijerph16122228.
- Results publication: PubMed 32558061O'Malley L, Powell R, Hulme S, Lievesley M, Westoby W, Zadik J, Bowen A, Brocklehurst P, Smith CJ. A qualitative exploration of oral health care among stroke survivors living in the community. Health Expect. 2020 Oct;23(5):1086-1095. doi: 10.1111/hex.13074. Epub 2020 Jun 19.
- Results publication: PubMed 28392215Dai R, Lam OLT, Lo ECM, Li LSW, McGrath C. A randomized clinical trial of oral hygiene care programmes during stroke rehabilitation. J Dent. 2017 Jun;61:48-54. doi: 10.1016/j.jdent.2017.04.001. Epub 2017 Apr 6.
- Results publication: PubMed 27628624Kim EK, Park EY, Sa Gong JW, Jang SH, Choi YH, Lee HK. Lasting effect of an oral hygiene care program for patients with stroke during in-hospital rehabilitation: a randomized single-center clinical trial. Disabil Rehabil. 2017 Nov;39(22):2324-2329. doi: 10.1080/09638288.2016.1226970. Epub 2016 Sep 15.
- Results publication: PubMed 21599846Chan EY, Lee YK, Poh TH, Ng IH, Prabhakaran L. Translating evidence into nursing practice: oral hygiene for care dependent adults. Int J Evid Based Healthc. 2011 Jun;9(2):172-83. doi: 10.1111/j.1744-1609.2011.00214.x.
- Results publication: PubMed 36810267Cardoso AF, Ribeiro LE, Santos T, Pinto M, Rocha C, Magalhaes J, Augusto B, Santos D, Duque FM, Fernandes BL, Sousa RC, Silva R, Ventura F, Fernandes AM, Cardoso D, Rodrigues R. Oral Hygiene in Patients with Stroke: A Best Practice Implementation Project Protocol. Nurs Rep. 2023 Jan 31;13(1):148-156. doi: 10.3390/nursrep13010016.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral hygiene care bundle in people with Stroke and Aspiration Pneumonia, run by Addis Ababa University at 1 site in Ethiopia.
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 4 inclusion and 4 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 2 Feb 2026. 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 Ethiopia. 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?
Incidence of Aspiration Pneumonia (time frame: From baseline (hospital admission) through hospital discharge, up to 21 days). 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 NCT07382089, which also lists 6 linked publications.
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 2 Feb 2026.