Effect of Applying Oral Hygiene Care on Swallowing in Stroke Patients With Oropharyngeal Dysphagia

May 27, 2025 updated by: University Hospital, Ghent

Effect of Applying Oral Hygiene Care on Swallowing in Stroke Patients With Oropharyngeal Dysphagia: A Multi-Arm Randomized Controlled Trial

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Data collection:

  1. At trial baseline (Before oral hygiene intervention)

    • 1.1. Socio-demographic data: age, gender, education, living conditions, and allowance for increased health care cost reimbursement
    • 1.2. Medical information: smoking habit, medications, and medical background such as stroke type and location, stroke history, National Institutes of Health Stroke Scale (NIHSS), and Functional Oral Intake Scale (FOIS),
    • 1.3. Dental information from oral examination:
    • Oral care ability
    • Oral hygiene index including dental plaque, tongue plaque, and denture plaque.
    • Oral disease: Periodontal status and sign of periodontitis as tooth mobility, clinical dental caries, and clinical mucosal lesions.
    • Oral status: the number of functional teeth, the number of posterior occluding pairs, and denture status
    • Clinical oral dryness scoring
    • 1.4. Tongue strength using maximum isometric pressure (MIP) from the Iowa Oral Performance Instrument (IOPI) during rest and swallowing stages
    • 1.5. Test of Masticating and Swallowing Solids (TOMASS): number of discrete bites, number of masticatory cycles, number of swallows, and total time
    • 1.6. Oral residue score (ORS)

  2. After oral hygiene intervention

    • 2.1. Clinical measurements
    • Modified TOMASS by using a half cracker: number of discrete bites, number of masticatory cycles, number of swallows, and total time
    • Tongue strength using MIP from IOPI during rest and swallowing stages
    • ORS
    • 2.2. Subjective measurements: Visual Analogue Scale (VAS)

Sample size:

Sample size calculations were based on both the primary and secondary objectives, focusing on the primary outcomes: number of masticatory cycles, number of swallows, and total time.

For both objectives, sample size estimation was conducted using an independent t-test to compare means in a superiority test between two groups, with an alpha level of 0.05 and a power of 0.80. G*Power software (version 3.1.9.2, Heinrich-Heine-Universität Düsseldorf, Düsseldorf, Germany) was used for the calculation. The effect size for the intervention was estimated based on the standard deviation (SD) from pilot data, combined with the clinically relevant mean difference determined by the research team using pilot data and previous studies comparing individuals with dysphagia to healthy individuals.

The required sample size, calculated using the smallest effect size corresponding to total time in the primary and secondary objectives, was 53 and 62 participants per group, respectively. These calculations were based on an SD of 40.2 with a clinically relevant mean difference of 22 seconds for the primary objective, and an SD of 21.7 with a clinically relevant mean difference of 11 seconds for the secondary objective.

To account for a 5% dropout rate, the final sample size was adjusted to 65 participants per group, resulting in a total of 260 participants.

Randomization:

Randomization was conducted using a 1:1:1:1 allocation ratio with variable block sizes of 4 and 8, with sequences independently generated using Microsoft Excel version 16 (Microsoft, New Mexico, USA). Allocation and data collection were managed through REDCap (Research Electronic Data Capture), hosted at Ghent University Hospital.

Statistical methods:

The primary analysis will evaluate the superiority of the combined care group over the control group. If statistical significance is achieved, a secondary analysis will compare the combined care group with the mechanical oral hygiene and mouth moisturization groups, respectively.

An exploratory analysis using hierarchical pairwise comparisons will be conducted if both comparisons in the secondary analysis and the statistical analysis across all four groups show significance. The pairwise comparisons will be ordered sequentially, first comparing the mouth moisturization group with the control group, then the mechanical oral hygiene group with the control group and finally comparing the mouth moisturization and mechanical oral hygiene groups with each other.

All analyses will be performed using analysis of covariance (ANCOVA), with pre-intervention outcomes as covariates and a significance level of 0.05.

To address missing data, multiple imputation will be applied. Sensitivity analyses will compare results from imputed data with those from complete case analysis to ensure the robustness of findings.

Study Type

Interventional

Enrollment (Estimated)

260

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Gent, Belgium, 9000
        • Ghent University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • A history of surgical intervention on the tongue.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Patients will receive oral cleaning using only water and gauze as a usual process.
Experimental: Mouth moisturization group
Patients will undergo oral cleaning with a water-based hydrating gel.
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 Names:
  • A
Experimental: Mechanical oral hygiene group
Patients with natural teeth/or denture will receive oral care using a mechanical oral hygiene care.
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.
Experimental: Combined care group
Patients will receive a comprehensive oral hygiene intervention incorporating mouth cleaning, mechanical oral hygiene, and moisturization.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Test of Mastication and Swallowing Solids (TOMASS): number of masticatory cycles
Time Frame: Before the intervention (baseline period) and immediately after the intervention on the same day.
This outcome assesses mastication and swallowing efficiency by counting the number of masticatory cycles, using half the standard amount of a cracker.
Before the intervention (baseline period) and immediately after the intervention on the same day.
Test of Mastication and Swallowing Solids (TOMASS): number of swallows
Time Frame: Before the intervention (baseline period) and immediately after the intervention on the same day.
This outcome assesses mastication and swallowing efficiency by counting the number of swallows, using half the standard amount of a cracker.
Before the intervention (baseline period) and immediately after the intervention on the same day.
Test of Mastication and Swallowing Solids (TOMASS): total time
Time Frame: Before the intervention (baseline period) and immediately after the intervention on the same day.
This outcome assesses mastication and swallowing efficiency by recording the total time (seconds) taken to consume half the standard amount of a cracker.
Before the intervention (baseline period) and immediately after the intervention on the same day.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Test of Mastication and Swallowing Solids (TOMASS): number of discrete bites
Time Frame: Before the intervention (baseline period) and immediately after the intervention on the same day.
This outcome assesses mastication and swallowing efficiency by counting the number of discrete bites, using half the standard amount of a cracker.
Before the intervention (baseline period) and immediately after the intervention on the same day.
Tongue strengthening performance
Time Frame: Before the intervention (baseline period) and immediately after the intervention on the same day.
This outcome assesses patients' ability to generate anterior maximum isometric pressure (MIP) during both the resting and swallowing stages, using the Iowa Oral Performance Instrument (IOPI).
Before the intervention (baseline period) and immediately after the intervention on the same day.
Oral residue score (ORS)
Time Frame: Before the intervention (baseline period) and immediately after the intervention on the same day.
The outcome assesses the oral residue remaining in patients' mouth after the TOMASS method, using a 4-point scale (0-3) to evaluate oral residue after eating a cracker in eight areas of the mouth, including the left teeth, right teeth, left sulcus and cheek, right sulcus and cheek, hard palate, soft palate, dorsum of the tongue, and floor of the mouth with a total score of 24.
Before the intervention (baseline period) and immediately after the intervention on the same day.
Patient's subjective measurements
Time Frame: Before the intervention (baseline period) and immediately after the intervention on the same day.

This outcome assesses the patient's experience in 9 topics using the Visual Analogue Scale (VAS), a 0-100 mm scale, where the 0-100 score indicates the patient's experience. The highest score could represent either worse or better experiences depending on each topic. The assessed topics include:

  • I cough when I eat a cracker
  • Chewing a cracker is easy
  • Swallowing a cracker is difficult
  • I experience pain when swallowing a cracker
  • There is food left in my mouth after eating a cracker
  • Placing the bulb in the correct location in my mouth is easy (for IOPI)
  • Pushing the bulb is difficult (for IOPI)
  • My mouth is dry
  • I have a pleasant feeling in my mouth
Before the intervention (baseline period) and immediately after the intervention on the same day.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Investigators

  • Principal Investigator: Barbara Janssens, Ghent University, Ghent, Belgium

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 21, 2025

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 31, 2027

Study Registration Dates

First Submitted

February 5, 2025

First Submitted That Met QC Criteria

February 20, 2025

First Posted (Actual)

February 26, 2025

Study Record Updates

Last Update Posted (Actual)

May 31, 2025

Last Update Submitted That Met QC Criteria

May 27, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONZ-2024-0245

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The IPD must be shared as anonymized or pseudonymized information, which may be included in a meta-analysis upon request. Data transfer must be conducted under Ghent University Hospital conditions, with legal experts drafting and reviewing the agreement (https://hiruz.be/cu/). Additionally, any data containing personal information requires approval from the Ethics Committee before transfer.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dysphagia After Stroke

Clinical Trials on Mouth moisturization

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Germany

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe