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

Dysphagia Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05680064
• Other study ID #: 2022/92
• Status: Completed
• Phase: N/A
• Start date: January 10, 2023
• Est. completion date: July 18, 2023

Study information

• Verified date: July 2023
• Source: Saglik Bilimleri Universitesi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: July 18, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia
• Sjogren's Syndrome
• Sjögren's Syndrome
• Syndrome
• Xerostomia

Intervention

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.

Locations

Country	Name	City	State
Turkey	Vicdan Itisgen	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Saglik Bilimleri Universitesi

Country where clinical trial is conducted

Turkey, 

References & Publications (11)

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. — View Citation

Basol ME, Karaagaçlioglu L, Yilmaz B. Türkçe Agiz Sagligi Etki Ölçeginin Gelistirilmesi OHIP-14-TR. Turkiye Klinikleri J Dental Sci. 2014; 20: 85-92.

Dalkiliç E, Coskun BN. Sjögren Sendromunda Sinir Sistemi Tutulumu ve Vaskülit. RAED Dergisi. 2014; 6(2):62-66.

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. — View Citation

Depinoy T, Saraux A, Pers JO, Boisrame S, Cornec D, Marhadour T, Guellec D, Devauchelle-Pensec V, Bressollette L, Jousse-Joulin S. Salivary Glands and Periodontal Changes in a Population of Sjogren's and Sicca Syndrome Treated by Pilocarpine: A Pilot Study. Rheumatol Ther. 2021 Mar;8(1):219-231. doi: 10.1007/s40744-020-00263-y. Epub 2020 Dec 17. — View Citation

Lopez-Pintor RM, Ramirez L, Serrano J, de Pedro M, Fernandez-Castro M, Casanas E, Hernandez G. Effects of Xerostom(R) products on xerostomia in primary Sjogren's syndrome: A randomized clinical trial. Oral Dis. 2019 Apr;25(3):772-780. doi: 10.1111/odi.13019. Epub 2019 Jan 8. — View Citation

Milin M, Cornec D, Chastaing M, Griner V, Berrouiguet S, Nowak E, Marhadour T, Saraux A, Devauchelle-Pensec V. Sicca symptoms are associated with similar fatigue, anxiety, depression, and quality-of-life impairments in patients with and without primary Sjogren's syndrome. Joint Bone Spine. 2016 Dec;83(6):681-685. doi: 10.1016/j.jbspin.2015.10.005. Epub 2016 Jan 13. — View Citation

Mumcu G, Biçakçigil M, Cimilli H, Toker, E, Atalay T, Yavuz S. Sjögren Sendromlu Hastalarda Agiz Sagliginin Degerlendirilmesi-Pilot Çalisma. EÜ Dis Hek Fak Derg. 2006; 27:39-44.

Orellana MF, Lagravere MO, Boychuk DG, Major PW, Flores-Mir C. Prevalence of xerostomia in population-based samples: a systematic review. J Public Health Dent. 2006 Spring;66(2):152-8. doi: 10.1111/j.1752-7325.2006.tb02572.x. — View Citation

Pinto A. Management of xerostomia and other complications of Sjogren's syndrome. Oral Maxillofac Surg Clin North Am. 2014 Feb;26(1):63-73. doi: 10.1016/j.coms.2013.09.010. — View Citation

Ramos-Casals M, Brito-Zeron P, Bombardieri S, Bootsma H, De Vita S, Dorner T, Fisher BA, Gottenberg JE, Hernandez-Molina G, Kocher A, Kostov B, Kruize AA, Mandl T, Ng WF, Retamozo S, Seror R, Shoenfeld Y, Siso-Almirall A, Tzioufas AG, Vitali C, Bowman S, Mariette X; EULAR-Sjogren Syndrome Task Force Group. EULAR recommendations for the management of Sjogren's syndrome with topical and systemic therapies. Ann Rheum Dis. 2020 Jan;79(1):3-18. doi: 10.1136/annrheumdis-2019-216114. Epub 2019 Oct 31. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	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.	It will be measured 2 times with a scale, with an interval of 15 days.
Secondary	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.	It will be measured 2 times with a scale, with an interval of 15 days.
Secondary	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.	It will be measured 2 times with a scale, with an interval of 15 days.