NCT05680064

The Effect of Chewing Gum, Exercises of the Tongue, Lip, Jaw on Salivation, Xerostomia, Dysphagia in Sjögren's Syndrome

The Effect of Chewing Gum and Exercises of the Tongue, Lip, and Jaw on Salivation, Xerostomia, and Dysphagia in Patients With Sjögren's Syndrome

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Saglik Bilimleri Universitesi · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Sjögren's Syndrome
• Xerostomia
• Dysphagia
• Salivary Flow Rate

Interventions

Type	Name	Description
BEHAVIORAL	Tongue, lip, chin exercise group	In order to evaluate the effect of chewing gum and tongue, lip and chin exercises on salivary flow rate, xerostomia and dysphagia, both intervention groups will work in a determined time frame daily.

Timeline

• Start date: 2023-01-10
• Primary completion: 2023-07-01
• Completion: 2023-07-18
• First posted: 2023-01-11
• Last updated: 2023-07-20

Locations

1 site across 1 country: Turkey (Türkiye)