Effect of Applying Oral Hygiene Care on Swallowing in Stroke Patients With Oropharyngeal Dysphagia: A Multi-Arm Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Test of Mastication and Swallowing Solids (TOMASS): number of masticatory cycles
研究概览
简要总结
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.
详细描述
Data collection:
- 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)
- 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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
- •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.
研究组 & 干预措施
Control group
Patients will receive oral cleaning using only water and gauze as a usual process.
Mouth moisturization group
Patients will undergo oral cleaning with a water-based hydrating gel.
干预措施: Mouth moisturization (Other)
Mechanical oral hygiene group
Patients with natural teeth/or denture will receive oral care using a mechanical oral hygiene care.
干预措施: Mechanical oral hygiene care (Other)
Combined care group
Patients will receive a comprehensive oral hygiene intervention incorporating mouth cleaning, mechanical oral hygiene, and moisturization.
干预措施: Combined care (Other)
结局指标
主要结局
Test of Mastication and Swallowing Solids (TOMASS): number of masticatory cycles
时间窗: 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.
Test of Mastication and Swallowing Solids (TOMASS): number of swallows
时间窗: 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.
Test of Mastication and Swallowing Solids (TOMASS): total time
时间窗: 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.
次要结局
- 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.)