Viewing Study NCT05680064



Ignite Creation Date: 2024-05-06 @ 6:29 PM
Last Modification Date: 2024-10-26 @ 2:49 PM
Study NCT ID: NCT05680064
Status: COMPLETED
Last Update Posted: 2023-07-20
First Post: 2022-12-04

Brief Title: The Effect of Chewing Gum Exercises of the Tongue Lip Jaw on Salivation Xerostomia Dysphagia in Sjögrens Syndrome
Sponsor: Saglik Bilimleri Universitesi
Organization: Saglik Bilimleri Universitesi

Study Overview

Official Title: The Effect of Chewing Gum and Exercises of the Tongue Lip and Jaw on Salivation Xerostomia and Dysphagia in Patients With Sjögrens Syndrome
Status: COMPLETED
Status Verified Date: 2023-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: SS
Brief Summary: Sjögrens 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 patients subjective perception of dry mouth hyposalivation is also evaluated objectively by salivary flow rate measurement methods Studies have reported that 09 to 648 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: Sjögrens 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 patients subjective perception of dry mouth hyposalivation is also evaluated objectively by salivary flow rate measurement methods Pinto 2021 Studies have reported that 09 to 648 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None