The Effect of Chewing Gum and Exercises of the Tongue, Lip, and Jaw on Salivation, Xerostomia, and Dysphagia in Patients With Sjögren's Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Simulated and Unsimulated Salivary Flow Rate
研究概览
简要总结
Sjögren's syndrome (SS) is a chronic, systemic and autoimmune disease characterized by inflammation, fibrosis and dysfunction of exocrine glands such as tear and salivary glands. SS is defined as primary SS when it progresses alone without any other rheumatic disease finding, while the definition of secondary SS is used in the presence of another accompanying autoimmune disease. One of the most disturbing symptoms of SS is hyposalivation, xerostomia and dysphagia due to hypofunction of salivary glands. While xerostomia is the patient's subjective perception of dry mouth, hyposalivation is also evaluated objectively by salivary flow rate measurement methods. Studies have reported that 0.9% to 64.8% of patients with SS experience xerostomia and 32% to 72% of them experience dysphagia. It was planned as a randomized controlled study to examine its effect on dysphagia.
详细描述
Sjögren's syndrome (SS) is a chronic, systemic and autoimmune disease characterized by inflammation, fibrosis, and dysfunction of exocrine glands such as tear and salivary glands. One of the most disturbing symptoms of SS is hyposalivation, xerostomia, and dysphagia due to the hypofunction of salivary glands. While xerostomia is the patient's subjective perception of dry mouth, hyposalivation is also evaluated objectively by salivary flow rate measurement methods (Pinto, 2021). Studies have reported that 0.9% to 64.8% of patients with SS experience xerostomia and 32% to 72% of them experience dysphagia (Orellana et al, 2016).
With the reduction of saliva, patients may experience difficulties in tasting, chewing, swallowing, speaking, and using prosthesis in patients using prostheses (Pinto, 2021). All these negatively affect the quality of life in patients with SS and their treatment is of great importance (Milin et al, 2016; Pinto, 2021). The treatment of dry mouth in patients with SS consists of pharmacological and non-pharmacological stimulation of the salivary glands and the use of artificial saliva preparations (Ramos_casals et al, 2020). Pharmacological methods used in patients with SS have been shown to reduce dry mouth, but these methods are mostly recommended in severe cases (Ramos_casals et al, 2020; Depinoy et al, 2021). In cases where pharmacological methods are not used, non-pharmacological methods such as taste stimulation (lozenge) and mechanical stimulation (gum) are also recommended in the control of dry mouth (Ramos_casals et al., 2020). It is known that chewing gum increases saliva secretion in studies conducted for different patient groups. used in the treatment of xerostomia in patients with SS, but no study has been found examining the relationship between chewing gum and salivation, xerostomia, and dysphagia in patients with SS (Ramos_casals et al, 2020). In the literature review, no study was found in which the effects of the tongue, lip, and jaw exercises on salivation, xerostomia, and dysphagia were evaluated in any patient group. This study was planned to examine the effects of chewing gum and tongue, lip, and jaw exercises on salivation, xerostomia, and dysphagia in patients with SS.
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
- None
盲法说明
At the beginning of this study, all participants are informed about in which group they will participate.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be diagnosed as SS according to the 2002 American and European Consensus Group SS classification criteria
- •Experiencing xerostomia and dysphagia
- •Being between the ages of 18-65
- •Not using a total denture
- •Not having any other serious illness that will cause dry mouth and dysphagia
- •Not having difficulty in chewing and tongue, lip, jaw movement
- •Have been receiving treatment for SS for at least 3 months
- •To be able to continue working physically and mentally
排除标准
- •Not wanting to participate in the study
- •Wanting to leave work voluntarily
结局指标
主要结局
Simulated and Unsimulated Salivary Flow Rate
时间窗: At the first interview, stimulated and unstimulated salivary flow rate of the patients will be measured. In the second interview after 15 days, stimulated and unstimulated salivary flow rate will be measured to observe the change in salivary flow rate.
Unstimulated Salivary Flow Rate: The patient will be placed in the Fawler position. Individuals will be asked to spit into the graduated tube for 5 minutes to collect saliva samples. The amount of saliva accumulated in the tube will be divided by 5 and the amount of saliva per minute (ml/min) will be calculated. Stimulated Salivary Flow Rate: The patient will be placed in the fawler position. Warning for collection of saliva samples will be provided with sugar-free gum. Individuals will be asked to hold the gum in their mouth until it becomes soft, chew for a few seconds, and swallow the first saliva formed. Then, they will be asked to continue the chewing movement using both sides of the jaw for 5 minutes and spit the saliva formed into the graduated tube at short intervals. The salivary flow rate will be calculated as ml/min by dividing the amount of saliva obtained after 5 minutes of chewing by the time.
次要结局
- Xerostomia(It will be measured 2 times with a scale, with an interval of 15 days.)
- Oral health-related quality of life(It will be measured 2 times with a scale, with an interval of 15 days.)
- Dysphagia(It will be measured 2 times with a scale, with an interval of 15 days.)
研究者
Vicdan İtişgen
Clinical Nurse Specialist
Saglik Bilimleri Universitesi