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

NCT05680064 | Completed DMC

• 1 other identifier: 2022/92
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Xerostomia,Hyposalivation,Mouth Dryness,Sjögren's syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Xerostomia

  It will be measured 2 times with a scale, with an interval of 15 days.

• Oral health-related quality of life

  It will be measured 2 times with a scale, with an interval of 15 days.

• Dysphagia

  It will be measured 2 times with a scale, with an interval of 15 days.

Study Arms (3)

Control

NO INTERVENTION

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.

Gum-Chewing Group

EXPERIMENTAL

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.

Behavioral: Tongue, lip, chin exercise group

Tongue, lip, chin exercise group

EXPERIMENTAL

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.

Behavioral: Tongue, lip, chin exercise group

Interventions

Tongue, lip, chin exercise group BEHAVIORAL

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.

Also known as: gum chewing group

Gum-Chewing Group; Tongue, lip, chin exercise group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Vicdan Itişgen

Ankara, 06310, Turkey (Türkiye)

Location

Related 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.

  PMID: 34165270 BACKGROUND

• Başol ME, Karaağaçlıoğlu L, Yılmaz B. Türkçe Ağız Sağlığı Etki Ölçeğinin Geliştirilmesi OHIP-14-TR. Turkiye Klinikleri J Dental Sci. 2014; 20: 85-92.

  BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 27405421 BACKGROUND

• 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.

  PMID: 33336287 BACKGROUND

• 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.

  PMID: 30561129 BACKGROUND

• 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.

  PMID: 26774177 BACKGROUND

• Mumcu G, Bıçakçıgil M, Cimilli H, Toker, E, Atalay T, Yavuz Ş. Sjögren Sendromlu Hastalarda Ağız Sağlığının Değerlendirilmesi-Pilot Çalışma. EÜ Diş Hek Fak Derg. 2006; 27:39-44.

  BACKGROUND

• 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.

  PMID: 16711637 BACKGROUND

• 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.

  PMID: 24287194 BACKGROUND

• 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.

  PMID: 31672775 BACKGROUND

MeSH Terms

Conditions

Sjogren's Syndrome; Xerostomia; Deglutition Disorders

Interventions

SMG1 protein, human

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Fatma I CINAR, Prof

  Saglik Bilimleri Universitesi

  PRINCIPAL INVESTIGATOR

• Muhammet CINAR, Prof

  Saglik Bilimleri Universitesi

  STUDY DIRECTOR

• Vicdan ITISGEN

  Saglik Bilimleri Universitesi

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: At the beginning of this study, all participants are informed about in which group they will participate.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Nurse Specialist

Model Details: experimental research

Study Record Dates

• First Submitted: December 4, 2022
• First Posted: January 11, 2023
• Study Start: January 10, 2023
• Primary Completion: July 1, 2023
• Study Completion: July 18, 2023
• Last Updated: July 20, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)