NCT06847217Enrolling by invitation
Effect of Applying Oral Hygiene Care on Swallowing in Stroke Patients With Oropharyngeal Dysphagia
Effect of Applying Oral Hygiene Care on Swallowing in Stroke Patients With Oropharyngeal Dysphagia: A Multi-Arm Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 31 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Post-stroke dysphagia (PSD) is a common condition, affecting over 40% of patients within hours to days following a stroke. It is associated with negative outcomes, including higher rates of mortality and dependency, incidence of aspiration, pneumonia, and malnutrition. The presence of dysphagia, combined with poor oral health, significantly increases the risk of these adverse outcomes. However, there is limited knowledge regarding the impact of oral care practices on these outcomes, as well as their effect on oral function and swallowing in acute stroke patients. The optimal approach to delivering oral care remains undefined, and practices vary widely among healthcare professionals. Many providers often avoid using toothbrushes or toothpaste due to concerns about the risk of aspiration, despite recommendations for their use. Electric and suction toothbrushes may offer effective alternatives, but their high cost and uncertain benefits in the context of an acute stroke pose challenges. This study aims to measure the immediate effects of three different oral hygiene protocols: on masticatory and swallowing abilities in stroke patients with oropharyngeal dysphagia during the acute and subacute phases. The protocols are mouth moisturization, mechanical oral hygiene, and combined care (mouth moisturization and mechanical oral hygiene). The primary objective is to evaluate the effect of combined care compared to a control group with care as usual. The secondary objective is to evaluate the other 2 oral hygiene protocols relative to combined care.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 260 (estimated)
- First submitted
- 5 Feb 2025
- Start date
- 21 May 2025
- Primary completion date
- 1 Oct 2027
- Lead sponsor
- University Hospital, Ghent
- Diseases
- Stroke
- NCT number
- NCT06847217
What you commit to
- Study type: Interventional
- Planned participants: 260
- From 21 May 2025 to the primary completion date, 1 Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- A history of surgical intervention on the tongue.
Other
- Edentulous individuals, both fully edentulous or edentulous in one dental arch, if they do not wear dentures.
- Patients with a penetration-aspiration scale (PAS) of 7 or 8 under flexible endoscopic evaluation of swallowing (FEES), at the international dysphagia diet standardisation initiative (IDDSI) level 7.
- Patients who cannot perform TOMASS, indicated by 25% or more of the amount of cracker's bolus that can be considered as the same cracker.
Who the study is looking for
- Patients enrolled in the stroke unit at Ghent University and diagnosed with oropharyngeal dysphagia.
- Agreement to participate in the study and having signed an informed consent form.
- Age over 18 years.
- Sufficient cognitive abilities and language skills to understand the swallowing exercises.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ghent university hospital Coordinator of this site? Confirm its status | Ghent | Belgium | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.