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

Primary Purpose

Sjögren's Syndrome, Xerostomia, Dysphagia

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Tongue, lip, chin exercise group
Sponsored by
Saglik Bilimleri Universitesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Sjögren's Syndrome focused on measuring Xerostomia,Hyposalivation,Mouth Dryness,Sjögren's syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vicdan Itişgen

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control

Gum-Chewing Group

Tongue, lip, chin exercise group

Arm Description

Patients who are routinely followed up will be included in the control group. At the end of 15 days, all patients will come to the second interview. The same data collection methods will be repeated after 15 days.

In the gum-chewing group, routine follow-up and additional gum-chewing training will be given (at least 10 minutes 4 times a day, preferably before meals and with sugar-free gum). Patients in the Gum Chewing Group will chew gum as recommended for 15 days. At the end of 15 days, all patients will come to the second interview. The same data collection methods will be repeated after 15 days. In the study, the chewing gum group will chew Vivident Xylit Full Fresh Mint Flavored Liquid Filled Sugar-Free Sweetener Gum. The contents of the gum; Sweeteners (Xylitol, Sorbitols, Mannitol, Maltitols, Aspartame, Acesulfame-K), Gum Yeast, Stabilizer (Glycerol), Flavorings, Natural Mint Flavoring, Maltodextrin, Starch, Emulsifiers (E473, Soy Lecithin), Green Tea Extract, Consistency Enhancers (Cellulose Gum, Xanthan Gum), Coconut Oil, Antioxidant (E321), Brightener (Carnauba Wax), Colorant (E133). There is no allergen warning.

In the tongue, lip and chin exercise group, patients who are routinely followed up and who will be given additional tongue, lip and jaw exercises training (at least 10 minutes 4 times a day and preferably before meals) will take place. Patients in Tongue, Lip, Chin Exercise Group will do the tongue, lip and chin exercises as recommended for 15 days. At the end of 15 days, all patients will come the second interview. The same data collection methods are repeated after 15 days. content of the training to be given to the tongue, lip and chin exercise group and the exercise brochure to be given to the patients T.C. Oral-Motor Exercises Brochure published by the Ministry of Health Istanbul Provincial Health Directorate, Basic Evaluation Principles in Treatment Movements book and Specialist. It was determined and prepared in line with the recommendations of physiotherapist İbrahim ÖZDEMİR.

Outcomes

Primary Outcome Measures

Simulated and Unsimulated 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.

Secondary Outcome Measures

Xerostomia
Xerostomia is the patient's subjective perception of dry mouth. The Xerostomia Inventory 11 will be used to evaluate xerostomia. Each item describing the symptoms will be marked between 1 and 5 points according to the degree of severity. The result is an overall score ranging from 11 to 55 points. A higher total score indicates more severe symptoms are present.
Oral health-related quality of life
It is the effect of diseases, deficiencies and inadequacies related to oral and dental health on the quality of life. Oral Health Impact Profile will be used. Items will be answered with points between 0 and 4. The lowest possible score is 0, while the highest score is 56. A high total score indicates a poor oral and dental health-related quality of life.
Dysphagia
It is a disorder in which swallowing time is prolonged and more force is used to swallow than normal. The Eating Assessment Tool is used to evaluate dysphagia symptom severity and response to treatment. Each item is scored from 0 to 4. The total score ranges from 0 to 40. A score approaching 0 in the questionnaire indicates that the severity of the swallowing disorder decreases, and a score closer to 40 indicates that the severity of the swallowing disorder increases.

Full Information

First Posted
December 4, 2022
Last Updated
July 18, 2023
Sponsor
Saglik Bilimleri Universitesi
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1. Study Identification

Unique Protocol Identification Number
NCT05680064
Brief Title
The Effect of Chewing Gum, Exercises of the Tongue, Lip, Jaw on Salivation, Xerostomia, Dysphagia in Sjögren's Syndrome
Acronym
SS
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 10, 2023 (Actual)
Primary Completion Date
July 1, 2023 (Actual)
Study Completion Date
July 18, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saglik Bilimleri Universitesi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sjögren's Syndrome, Xerostomia, Dysphagia, Salivary Flow Rate
Keywords
Xerostomia,Hyposalivation,Mouth Dryness,Sjögren's syndrome

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
experimental research
Masking
None (Open Label)
Masking Description
At the beginning of this study, all participants are informed about in which group they will participate.
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients who are routinely followed up will be included in the control group. At the end of 15 days, all patients will come to the second interview. The same data collection methods will be repeated after 15 days.
Arm Title
Gum-Chewing Group
Arm Type
Experimental
Arm Description
In the gum-chewing group, routine follow-up and additional gum-chewing training will be given (at least 10 minutes 4 times a day, preferably before meals and with sugar-free gum). Patients in the Gum Chewing Group will chew gum as recommended for 15 days. At the end of 15 days, all patients will come to the second interview. The same data collection methods will be repeated after 15 days. In the study, the chewing gum group will chew Vivident Xylit Full Fresh Mint Flavored Liquid Filled Sugar-Free Sweetener Gum. The contents of the gum; Sweeteners (Xylitol, Sorbitols, Mannitol, Maltitols, Aspartame, Acesulfame-K), Gum Yeast, Stabilizer (Glycerol), Flavorings, Natural Mint Flavoring, Maltodextrin, Starch, Emulsifiers (E473, Soy Lecithin), Green Tea Extract, Consistency Enhancers (Cellulose Gum, Xanthan Gum), Coconut Oil, Antioxidant (E321), Brightener (Carnauba Wax), Colorant (E133). There is no allergen warning.
Arm Title
Tongue, lip, chin exercise group
Arm Type
Experimental
Arm Description
In the tongue, lip and chin exercise group, patients who are routinely followed up and who will be given additional tongue, lip and jaw exercises training (at least 10 minutes 4 times a day and preferably before meals) will take place. Patients in Tongue, Lip, Chin Exercise Group will do the tongue, lip and chin exercises as recommended for 15 days. At the end of 15 days, all patients will come the second interview. The same data collection methods are repeated after 15 days. content of the training to be given to the tongue, lip and chin exercise group and the exercise brochure to be given to the patients T.C. Oral-Motor Exercises Brochure published by the Ministry of Health Istanbul Provincial Health Directorate, Basic Evaluation Principles in Treatment Movements book and Specialist. It was determined and prepared in line with the recommendations of physiotherapist İbrahim ÖZDEMİR.
Intervention Type
Behavioral
Intervention Name(s)
Tongue, lip, chin exercise group
Other Intervention Name(s)
gum chewing group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Simulated and Unsimulated Salivary Flow Rate
Description
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.
Time Frame
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 Outcome Measure Information:
Title
Xerostomia
Description
Xerostomia is the patient's subjective perception of dry mouth. The Xerostomia Inventory 11 will be used to evaluate xerostomia. Each item describing the symptoms will be marked between 1 and 5 points according to the degree of severity. The result is an overall score ranging from 11 to 55 points. A higher total score indicates more severe symptoms are present.
Time Frame
It will be measured 2 times with a scale, with an interval of 15 days.
Title
Oral health-related quality of life
Description
It is the effect of diseases, deficiencies and inadequacies related to oral and dental health on the quality of life. Oral Health Impact Profile will be used. Items will be answered with points between 0 and 4. The lowest possible score is 0, while the highest score is 56. A high total score indicates a poor oral and dental health-related quality of life.
Time Frame
It will be measured 2 times with a scale, with an interval of 15 days.
Title
Dysphagia
Description
It is a disorder in which swallowing time is prolonged and more force is used to swallow than normal. The Eating Assessment Tool is used to evaluate dysphagia symptom severity and response to treatment. Each item is scored from 0 to 4. The total score ranges from 0 to 40. A score approaching 0 in the questionnaire indicates that the severity of the swallowing disorder decreases, and a score closer to 40 indicates that the severity of the swallowing disorder increases.
Time Frame
It will be measured 2 times with a scale, with an interval of 15 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatma I CINAR, Prof
Organizational Affiliation
Saglik Bilimleri Universitesi
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Muhammet CINAR, Prof
Organizational Affiliation
Saglik Bilimleri Universitesi
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Vicdan ITISGEN
Organizational Affiliation
Saglik Bilimleri Universitesi
Official's Role
Study Chair
Facility Information:
Facility Name
Vicdan Itişgen
City
Ankara
ZIP/Postal Code
06310
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34165270
Citation
Basakci Calik B, Gur Kabul E, Keskin A, Bozcuk S, Senol H, Cobankara V. Translation and validation of a Turkish version of the Xerostomia Inventory XI in patients with primary Sjogren's syndrome. Turk J Med Sci. 2021 Oct 21;51(5):2477-2484. doi: 10.3906/sag-2005-157.
Results Reference
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Dalkılıç E, Coşkun BN. Sjögren Sendromunda Sinir Sistemi Tutulumu ve Vaskülit. RAED Dergisi. 2014; 6(2):62-66.
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PubMed Identifier
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Citation
Demir N, Serel Arslan S, Inal O, Karaduman AA. Reliability and Validity of the Turkish Eating Assessment Tool (T-EAT-10). Dysphagia. 2016 Oct;31(5):644-9. doi: 10.1007/s00455-016-9723-9. Epub 2016 Jul 12.
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PubMed Identifier
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The Effect of Chewing Gum, Exercises of the Tongue, Lip, Jaw on Salivation, Xerostomia, Dysphagia in Sjögren's Syndrome

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