Clinical trial NCT05680064: The Effect of Chewing Gum, Exercises of the Tongue, Lip, Jaw on Salivation, Xerostomia, Dysphagia in Sjögren's Syndrome
Official title: The Effect of Chewing Gum and Exercises of the Tongue, Lip, and Jaw on Salivation, Xerostomia, and Dysphagia in Patients With Sjögren's Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sjögren's Syndrome
Xerostomia
Dysphagia
Salivary Flow Rate
Keywords: Xerostomia,Hyposalivation,Mouth Dryness,Sjögren's syndrome
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2023-01-11
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: experimental research
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Not wanting to participate in the study
* Wanting to leave work voluntarily

Primary outcomes:
measure: Simulated and Unsimulated Salivary Flow Rate
timeFrame: 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.
Secondary outcomes:
measure: Xerostomia
timeFrame: It will be measured 2 times with a scale, with an interval of 15 days.
measure: Oral health-related quality of life
timeFrame: It will be measured 2 times with a scale, with an interval of 15 days.
measure: Dysphagia
timeFrame: It will be measured 2 times with a scale, with an interval of 15 days.
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Vicdan Itişgen
Study officials:
affiliation: Saglik Bilimleri Universitesi
name: Fatma I CINAR, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Saglik Bilimleri Universitesi
name: Muhammet CINAR, Prof
role: STUDY_DIRECTOR
affiliation: Saglik Bilimleri Universitesi
name: Vicdan ITISGEN
role: STUDY_CHAIR
References:
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