Effect of Applying Oral Hygiene Care on Swallowing in Stroke Patients With Oropharyngeal Dysphagia
NCT06847217 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 260
Last updated 2025-05-31
Summary
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.
Conditions
- Dysphagia After Stroke
Interventions
- OTHER
-
Mouth moisturization
This intervention will include mouth cleaning with water and gauze to remove plaque and debris. Water-based hydrating gels (bioXtra Dry Mouth Oral Gel, Lifestream Pharma N.V., Seneffe, Belgium) will be then applied to all oral structures, including the lips, tongue, palate, and cheeks, using gloved fingers or a small toothbrush. In the presence of dried secretions, the gels will be massaged into these areas and left to act for a few minutes to facilitate removal and reduce patient discomfort.
- OTHER
-
Mechanical oral hygiene care
Patients with natural teeth will be treated using a soft toothbrush and a sodium lauryl sulfate-free fluoride toothpaste (meridol® toothpaste, Colgate-Palmolive Company, Belgium). The teeth will be brushed using the modified BASS technique. Subsequently, the tongue will be cleaned with either a scraper. For participants wearing dentures, the dentures will be cleaned using a denture brush and soap.
- OTHER
-
Combined care
Patients will receive a comprehensive oral hygiene intervention incorporating mouth cleaning, mechanical oral hygiene, and moisturization. The procedure will begin with oral cleaning using water and gauze, followed by mechanical oral hygiene, and conclude with the application of the hydrating gel.
Sponsors & Collaborators
-
University Hospital, Ghent
lead OTHER
Principal Investigators
-
Barbara Janssens · Ghent University, Ghent, Belgium
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-05-21
- Primary Completion
- 2027-10-01
- Completion
- 2027-10-31
Countries
- Belgium
Study Locations
More Related Trials
-
GEL & MEDication Dysphagia
NCT07254663 ·Status: RECRUITING
-
A Randomized Controlled Trial of a Water Protocol for Clients With Thin Liquid Dysphagia
NCT00616512 ·Status: COMPLETED ·Phase: PHASE1
-
The Correlation Between COVID-19 and Dysphagia in Adults With Swallowing Disorders
NCT06135207 ·Status: COMPLETED
-
The Role of Periodontal Diseases and Stimulation of Saliva Secretion in the Acute Phase of Ischemic Stroke
NCT05394090 ·Status: COMPLETED ·Phase: NA
-
Testing of a New Scale Measuring Medical Outcomes of Dysphagia (MOD) in Adult Patients With Swallowing Disorders
NCT01419886 ·Status: COMPLETED
-
RISK FACTOR ANALYSIS OF CHEWING AND SWALLOWING PERFORMANCE IN GERIATRICS
NCT06491407 ·Status: RECRUITING
-
Physiological Flow of Liquids Used in Dysphagia Management (Neuro)
NCT03192358 ·Status: COMPLETED
-
Investigation of a Free Water Protocol
NCT06309602 ·Status: RECRUITING ·Phase: NA
-
Assessing Fatiguability of Tongue Muscles in MS
NCT03817073 ·Status: UNKNOWN ·Phase: NA
-
Acceptance of Different Thickeners in Dysphagia
NCT04305860 ·Status: COMPLETED ·Phase: NA
-
Effect of Carbonated Water on Swallowing
NCT06563960 ·Status: ENROLLING_BY_INVITATION ·Phase: NA
-
Evaluate the Link Between the Characteristics of Oral Physiology and the Formation of the Food Bolus During the Consumption of Cereal Products in Elderly People
NCT03227887 ·Status: COMPLETED ·Phase: NA
-
Feasibility of a Water-soluble Contrast Application Into Dysphagia Evaluation
NCT03598491 ·Status: COMPLETED
-
Interest of Auriculotherapy in the Treatment of Xerostomia
NCT04222478 ·Status: RECRUITING ·Phase: NA
-
Impact of Oral Supplementation With Bioactive Collagen Peptides and Other Functional Ingredients
NCT07151482 ·Status: NOT_YET_RECRUITING
-
Interventions for Patients With Alzheimer's Disease and Dysphagia
NCT03682081 ·Status: COMPLETED ·Phase: NA
-
Evaluation of the Use of a Novel Oral Health Screening Instrument by Caregivers in Nursing Homes
NCT06536322 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Oral and Swallowing Function in Older Adults
NCT06368830 ·Status: RECRUITING
-
Clinical Evaluation of Oral Rinse for Xerostomia
NCT04289051 ·Status: COMPLETED ·Phase: NA
-
CLINICAL EVALUATION OF THE EFFICACY OF AN INTRA ORAL SPRAY FOR PATIENTS WITH XEROSTOMIA
NCT04719091 ·Status: COMPLETED ·Phase: NA
-
Influence of Two Paraffin Wax Chewing Gums of Different Consistency on the Stimulated Saliva Flow Rate
NCT04661761 ·Status: COMPLETED ·Phase: NA
-
OGT Spray in the Management of Xerostomia in the Elderly
NCT00350350 ·Status: COMPLETED
-
Efficacy Study of Oxygenated Glycerol Triesters to Treat Xerostomia
NCT00332618 ·Status: COMPLETED
-
Xerostomia in Patients With a Life-limiting Condition or Frailty
NCT05506137 ·Status: UNKNOWN ·Phase: PHASE3
-
Effects of Denture-Related Stomatitis on Blood Pressure in Denture Wearers
NCT02166450 ·Status: UNKNOWN