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Dysphagia After StrokeNCT06847217

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

A study testing Mouth moisturization, Mechanical oral hygiene care and Combined care in people with Dysphagia After Stroke, run by University Hospital, Ghent at 1 site in Belgium.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Dysphagia After Stroke
What is being tested?
Mouth moisturization, Mechanical oral hygiene care and Combined care
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
260 participants
Where
1 siteBelgium
Study dates
21 May 2025to 31 Oct 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Belgium1 site

  • Ghent University Hospital

    Ghent, 9000

Other trials in Belgium

About this study

Official title: 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.

Read the 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)
  1. 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.

Being tested
Mouth moisturization, Mechanical oral hygiene care, Combined care
Keywords
Stroke, Deglutition, Dysphagia, Oral care, Swallowing disorder
Medical subject headings
Stroke, Deglutition Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mouth moisturizationOther

    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.

  • Mechanical oral hygiene careOther

    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.

  • Combined careOther

    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.

Study groups in NCT06847217
Study groupRoleWhat they receive
Control groupNo interventionPatients will receive oral cleaning using only water and gauze as a usual process.
Mouth moisturization groupExperimentalPatients will undergo oral cleaning with a water-based hydrating gel.
Receives: Other: Mouth moisturization
Mechanical oral hygiene groupExperimentalPatients with natural teeth/or denture will receive oral care using a mechanical oral hygiene care.
Receives: Other: Mechanical oral hygiene care
Combined care groupExperimentalPatients will receive a comprehensive oral hygiene intervention incorporating mouth cleaning, mechanical oral hygiene, and moisturization.
Receives: Other: Combined care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Test of Mastication and Swallowing Solids (TOMASS): number of masticatory cycles

    This outcome assesses mastication and swallowing efficiency by counting the number of masticatory cycles, using half the standard amount of a cracker.

    Measured: Before the intervention (baseline period) and immediately after the intervention on the same day.

  2. Test of Mastication and Swallowing Solids (TOMASS): number of swallows

    This outcome assesses mastication and swallowing efficiency by counting the number of swallows, using half the standard amount of a cracker.

    Measured: Before the intervention (baseline period) and immediately after the intervention on the same day.

  3. Test of Mastication and Swallowing Solids (TOMASS): total time

    This outcome assesses mastication and swallowing efficiency by recording the total time (seconds) taken to consume half the standard amount of a cracker.

    Measured: Before the intervention (baseline period) and immediately after the intervention on the same day.

Secondary outcomes (4)

  1. Test of Mastication and Swallowing Solids (TOMASS): number of discrete bites

    This outcome assesses mastication and swallowing efficiency by counting the number of discrete bites, using half the standard amount of a cracker.

    Measured: Before the intervention (baseline period) and immediately after the intervention on the same day.

  2. Tongue strengthening performance

    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).

    Measured: Before the intervention (baseline period) and immediately after the intervention on the same day.

  3. Oral residue score (ORS)

    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.

    Measured: Before the intervention (baseline period) and immediately after the intervention on the same day.

  4. Patient's subjective measurements

    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

    Measured: Before the intervention (baseline period) and immediately after the intervention on the same day.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2025
  2. Study start21 May 2025
  3. Primary completion1 Oct 2027 (estimated)
  4. Study completion31 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study was designed as a multi-arm randomized controlled trial (RCT) comprising four groups: a control group, a mouth moisturization group, a mechanical oral hygiene group, and a combined care group. Patients in each group will be blinded to the intervention, and the primary outcomes measured by the test of masticating and swallowing solids (TOMASS) will be recorded and sent to a blinded examiner.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
260 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06847217
Sponsor's protocol ID
ONZ-2024-0245
Status last verified
May 2025
First submitted
5 Feb 2025
Last updated
31 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • Das P, Challacombe SJ. Dry Mouth and Clinical Oral Dryness Scoring Systems. Prim Dent J. 2016 Feb 1;5(1):77-79. doi: 10.1177/205016841600500110.

    PubMed 29029657

  • Ismail AI, Sohn W, Tellez M, Amaya A, Sen A, Hasson H, Pitts NB. The International Caries Detection and Assessment System (ICDAS): an integrated system for measuring dental caries. Community Dent Oral Epidemiol. 2007 Jun;35(3):170-8. doi: 10.1111/j.1600-0528.2007.00347.x.

    PubMed 17518963

  • Wu CP, Tu YK, Lu SL, Chang JH, Lu HK. Quantitative analysis of Miller mobility index for the diagnosis of moderate to severe periodontitis - A cross-sectional study. J Dent Sci. 2018 Mar;13(1):43-47. doi: 10.1016/j.jds.2017.11.001. Epub 2018 Feb 3.

    PubMed 30895093

  • Van der Velden U. The Dutch periodontal screening index validation and its application in The Netherlands. J Clin Periodontol. 2009 Dec;36(12):1018-24. doi: 10.1111/j.1600-051X.2009.01495.x.

    PubMed 19929955

  • Janssens LE, Temmerman E, Maertens J, De Visschere L, Petrovic M, Janssens BE. A comparative analysis of oral hygiene in nursing homes with and without a structured oral healthcare programme. Gerodontology. 2025 Mar;42(1):78-85. doi: 10.1111/ger.12773. Epub 2024 Jun 21.

    PubMed 39959995

  • Franciotti R, Di Maria E, D'Attilio M, Aprile G, Cosentino FG, Perrotti V. Quantitative Measurement of Swallowing Performance Using Iowa Oral Performance Instrument: A Systematic Review and Meta-Analysis. Biomedicines. 2022 Sep 18;10(9):2319. doi: 10.3390/biomedicines10092319.

    PubMed 36140420

  • Todaro F, Pizzorni N, Scarponi L, Ronzoni C, Huckabee ML, Schindler A. The Test of Masticating and Swallowing Solids (TOMASS): Reliability and validity in patients with dysphagia. Int J Lang Commun Disord. 2021 May;56(3):558-566. doi: 10.1111/1460-6984.12613. Epub 2021 Mar 9.

    PubMed 33687133

  • Huckabee ML, McIntosh T, Fuller L, Curry M, Thomas P, Walshe M, McCague E, Battel I, Nogueira D, Frank U, van den Engel-Hoek L, Sella-Weiss O. The Test of Masticating and Swallowing Solids (TOMASS): reliability, validity and international normative data. Int J Lang Commun Disord. 2018 Jan;53(1):144-156. doi: 10.1111/1460-6984.12332. Epub 2017 Jul 5.

    PubMed 28677236

  • Cohen DL, Roffe C, Beavan J, Blackett B, Fairfield CA, Hamdy S, Havard D, McFarlane M, McLauglin C, Randall M, Robson K, Scutt P, Smith C, Smithard D, Sprigg N, Warusevitane A, Watkins C, Woodhouse L, Bath PM. Post-stroke dysphagia: A review and design considerations for future trials. Int J Stroke. 2016 Jun;11(4):399-411. doi: 10.1177/1747493016639057. Epub 2016 Mar 22.

    PubMed 27006423

Questions about this trial

What is this clinical trial studying?

A study testing Mouth moisturization, Mechanical oral hygiene care and Combined care in people with Dysphagia After Stroke, run by University Hospital, Ghent at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06847217, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.

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