Effect of Oral Hygiene Care on Prevention of Aspiration Pneumonia Among Hospitalized Stroke Patients

NCT07382089 | Completed DMC

• 1 other identifier: TASH_OH_STROKE_AP1
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stroke; Aspiration Pneumonia

Keywords

Oral hygiene; Aspiration pneumonia prevention; Stroke patients; Dysphagia; Hospital-acquired pneumonia

Outcome Measures

Primary Outcomes (1)

• 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.

  From baseline (hospital admission) through hospital discharge, up to 21 days

Study Arms (2)

Oral Hygiene Care Intervention

EXPERIMENTAL

Patients admitted after implementation of a structured oral hygiene care protocol delivered by trained nursing staff during hospitalization.

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.

Interventions

Oral hygiene care bundle BEHAVIORAL

A structured oral hygiene care protocol including regular oral cavity cleaning and toothbrushing during hospitalization.

Also known as: Oral hygiene

Oral Hygiene Care Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Addis Ababa University: lead

Study Sites (1)

Tikur Anbessa Specialized Hospital, Addis Ababa University

Addis Ababa, Addis Ababa, 26901, Ethiopia

Location

Related Publications (6)

• 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.

  PMID: 31238591 RESULT

• O'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.

  PMID: 32558061 RESULT

• Dai 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.

  PMID: 28392215 RESULT

• Kim 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.

  PMID: 27628624 RESULT

• Chan 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.

  PMID: 21599846 RESULT

• Cardoso 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.

  PMID: 36810267 RESULT

MeSH Terms

Conditions

Stroke; Pneumonia, Aspiration; Deglutition Disorders; Healthcare-Associated Pneumonia

Interventions

Oral Hygiene

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pneumonia; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Cross Infection; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hygiene; Therapeutics; Preventive Dentistry; Dentistry

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 2, 2026
• Study Start: May 1, 2023
• Primary Completion: January 30, 2024
• Study Completion: January 30, 2024
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ET (1)