Clinical trial NCT06847217: Effect of Applying Oral Hygiene Care on Swallowing in Stroke Patients With Oropharyngeal Dysphagia
Official title: Effect of Applying Oral Hygiene Care on Swallowing in Stroke Patients With Oropharyngeal Dysphagia: A Multi-Arm Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Dysphagia After Stroke
Keywords: Stroke
Deglutition
Dysphagia
Oral care
Swallowing disorder
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2025-02-26
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Test of Mastication and Swallowing Solids (TOMASS): number of masticatory cycles
timeFrame: Before the intervention (baseline period) and immediately after the intervention on the same day.
measure: Test of Mastication and Swallowing Solids (TOMASS): number of swallows
timeFrame: Before the intervention (baseline period) and immediately after the intervention on the same day.
measure: Test of Mastication and Swallowing Solids (TOMASS): total time
timeFrame: Before the intervention (baseline period) and immediately after the intervention on the same day.
Secondary outcomes:
measure: Test of Mastication and Swallowing Solids (TOMASS): number of discrete bites
timeFrame: Before the intervention (baseline period) and immediately after the intervention on the same day.
measure: Tongue strengthening performance
timeFrame: Before the intervention (baseline period) and immediately after the intervention on the same day.
measure: Oral residue score (ORS)
timeFrame: Before the intervention (baseline period) and immediately after the intervention on the same day.
measure: Patient's subjective measurements
timeFrame: Before the intervention (baseline period) and immediately after the intervention on the same day.
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: Ghent University Hospital
Study officials:
affiliation: Ghent University, Ghent, Belgium
name: Barbara Janssens
role: PRINCIPAL_INVESTIGATOR
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