Oral Status as Predictors of Stroke-Associated Pneumonia and Swallowing Recovery in Patients With Post-Stroke Dysphagia

NCT ID: NCT07059351

Last Updated: 2025-07-17

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 260 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-07-02
• Study Completion Date: 2027-07-31

Brief Summary

Post-stroke dysphagia (PSD) is a common condition that significantly impacts recovery and increases the risk of complications such as pneumonia, malnutrition, and prolonged hospital stays. Early identification and management are essential, as emphasized in several international clinical guidelines. However, predicting which patients will develop stroke-associated pneumonia (SAP) or experience delayed swallowing recovery remains a challenge. Recent evidence suggests that oral health status-including hygiene, tongue strength, and dental support-may play a key role in these outcomes. Assessing oral health could therefore aid in identifying high-risk patients and improving rehabilitation strategies.

Study Design and Setting A cohort study was designed with prospective data collection, conducted in parallel with a randomized controlled trial (RCT) at the stroke unit of Ghent University Hospital, Ghent, Belgium (ONZ-2024-0245). Data collection is expected to occur over two years, from 2025 to 2027.

The RCT is a one-day experimental study investigating the immediate effects of oral hygiene care on swallowing and masticatory functions. The interventions performed in this clinical study involve routine oral care procedures and are not expected to influence the outcomes of the cohort study.

Participants Participants will be recruited from all consecutive patients admitted to the stroke unit at Ghent University Hospital with ischemic or hemorrhagic stroke and a diagnosis of oropharyngeal dysphagia. For the diagnosis of oropharyngeal dysphagia, all patients will be restricted from oral intake upon arrival until a stroke nurse completes a step-by-step standardized protocol to screen for swallowing disorders.

Detailed Description

Data Collection A team of trained dental professionals and speech therapists will collect demographic and clinical data within the first three days after admission and will monitor cohort outcomes at day seven post-admission and weekly thereafter until discharge.

During the initial visit, baseline characteristics-including socio-demographic, medical, and clinical information-will be documented, with a specific focus on oral health status. Socio-demographic data will include age, gender, education level, living situation, and eligibility for increased healthcare cost reimbursement. Medical history will include smoking status, body mass index (BMI), medication use, stroke type, stroke location, and prior stroke events. Standardized assessment scores-namely the National Institutes of Health Stroke Scale (NIHSS), the Modified Rankin Scale (mRS), and the Functional Oral Intake Scale (FOIS)-will also be recorded. These data will be obtained from medical records and patient interviews conducted by the research team.

Oral status assessment includes two main components: dental information, and oral and masticatory function. Dental data will be gathered by a dentist using a standard dental probe, mirror, and headlamp at the bedside. Documented parameters will include oral care capacity, oral hygiene indices (dental plaque using a modified Turesky-Quigley-Hein index, tongue plaque via Winkel's index, and denture plaque assessed with the Augsburger and Elahi index). Additionally, oral disease status will be evaluated by measuring periodontal condition (Dutch Periodontal Screening Index - DPSI), tooth mobility (Miller's classification), clinical caries (International Caries Detection and Assessment System - ICDAS), and denture stomatitis (Newton's classification). Further oral status indicators will include the number of functional teeth, the number of posterior occluding pairs, denture status, and clinical signs of oral dryness.

Oral and masticatory function will be assessed using the Test of Masticating and Swallowing Solids (TOMASS), which evaluates the number of masticatory cycles, swallows, total time, and discrete bites while consuming a standardized cracker. Tongue strength will be measured using the Iowa Oral Performance Instrument during both resting and swallowing phases. Residual oral content will be scored using the Oral Residue Score-a 4-point scale (0-3) across eight oral regions: left teeth, right teeth, left sulcus and cheek, right sulcus and cheek, hard palate, soft palate, tongue dorsum, and floor of the mouth-yielding a maximum score of 24.

Conditions

Dsyphagia After Stroke

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Acute stroke with dysphagia

Acute stroke patients with dysphagia

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Patients admitted to the stroke unit at Ghent University Hospital with ischemic or hemorrhagic stroke who are diagnosed with oropharyngeal dysphagia.
• Patients over 18 years of age with sufficient cognitive abilities and language skills to understand the swallowing exercises.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ghent University Hospital

Ghent, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Sungkrit Pojmonpiti

Role: CONTACT

sungkrit.pojmonpiti@ugent.be

+32456398999

Facility Contacts

Sungkrit Pojmonpiti

Role: primary

sungkrit.pojmonpiti@ugent.be

+32456398999

Barbara Janssens

Role: backup

barbarae.janssens@ugent.be

+32473615130

Other Identifiers

ONZ-2025-0250

Identifier Type: -

Identifier Source: org_study_id