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

NCT06847217 | Enrolling By Invitation

• 1 other identifier: ONZ-2024-0245
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Stroke; Deglutition; Dysphagia; Oral care; Swallowing disorder

Outcome Measures

Primary Outcomes (3)

• 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.

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

• 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.

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

• 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.

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

Secondary Outcomes (4)

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

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

• Tongue strengthening performance

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

• Oral residue score (ORS)

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

• Patient's subjective measurements

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

Study Arms (4)

Control group

NO INTERVENTION

Patients will receive oral cleaning using only water and gauze as a usual process.

Mouth moisturization group

EXPERIMENTAL

Patients will undergo oral cleaning with a water-based hydrating gel.

Other: Mouth moisturization

Mechanical oral hygiene group

EXPERIMENTAL

Patients with natural teeth/or denture will receive oral care using a mechanical oral hygiene care.

Other: Mechanical oral hygiene care

Combined care group

EXPERIMENTAL

Patients will receive a comprehensive oral hygiene intervention incorporating mouth cleaning, mechanical oral hygiene, and moisturization.

Other: Combined care

Interventions

Mouth moisturization OTHER

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.

Mouth moisturization group

Mechanical oral hygiene care OTHER

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.

Mechanical oral hygiene group

Combined care OTHER

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.

Combined care group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

Location

Related Publications (9)

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  PMID: 29029657 BACKGROUND

• 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.

  PMID: 17518963 BACKGROUND

• 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.

  PMID: 30895093 BACKGROUND

• 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.

  PMID: 19929955 BACKGROUND

• 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.

  PMID: 39959995 BACKGROUND

• 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.

  PMID: 36140420 BACKGROUND

• 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.

  PMID: 33687133 BACKGROUND

• 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.

  PMID: 28677236 BACKGROUND

• 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.

  PMID: 27006423 BACKGROUND

MeSH Terms

Conditions

Stroke; Deglutition Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Barbara Janssens

  Ghent University, Ghent, Belgium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 26, 2025
• Study Start: May 21, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)