Sponsor study identifier
interventional
86
1 country
1
Study Start
January 10, 2023
Actual (reported)Primary Completion
July 1, 2023
Actual (reported)Study Completion
July 18, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 18, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 4, 2022
Actual (reported)January 10, 2023
Actual (reported)January 11, 2023
Actual (reported)July 1, 2023
Actual (reported)July 18, 2023
Actual (reported)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.
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.
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 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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Vicdan Itişgen
Ankara, 06310, Turkey (Türkiye)
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.
Başol ME, Karaağaçlıoğlu L, Yılmaz B. Türkçe Ağız Sağlığı Etki Ölçeğinin Geliştirilmesi OHIP-14-TR. Turkiye Klinikleri J Dental Sci. 2014; 20: 85-92.
Dalkılıç E, Coşkun BN. Sjögren Sendromunda Sinir Sistemi Tutulumu ve Vaskülit. RAED Dergisi. 2014; 6(2):62-66.
Fatma I CINAR, Prof
Saglik Bilimleri Universitesi
Muhammet CINAR, Prof
Saglik Bilimleri Universitesi
Vicdan ITISGEN
Saglik Bilimleri Universitesi
86 participants (actual enrollment reported by the registry).
First Submitted
December 4, 2022
First Posted
January 11, 2023
Study Start
January 10, 2023
Action Observation Therapy Program in Patients With Neurogenic Dysphagia
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.
Contact the study team to confirm eligibility.
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.
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.
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.
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.
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.
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.
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.
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.
Primary Completion
July 1, 2023
Actual (reported)Study Completion
July 18, 2023
Actual (reported)Last Updated
July 20, 2023
Record last verified: 2023-07
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