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Effectiveness of an Oral Exercise Program for Xerostomia in Patients With Sjögren Disease
Sponsor: Nazli Elif Nacar
Summary
Sjögren disease (SjD) is a chronic autoimmune disease in which salivary gland dysfunction commonly causes persistent dry mouth (xerostomia). Although oral dryness is a major and burdensome symptom, evidence for effective non-pharmacological interventions remains limited. This randomized controlled trial will investigate whether a structured oral exercise program improves xerostomia in adults with Sjögren disease. Participants will be randomly allocated to either an intervention group receiving a structured oral exercise program in addition to standardized oral hygiene education and usual medical care, or a control group receiving standardized oral hygiene education and usual medical care alone. The oral exercise program will be performed twice daily for 6 weeks. The primary outcome will be the between-group difference in change in Xerostomia Inventory score from baseline to week 6. Secondary outcomes will include salivary flow, oral health-related quality of life, swallowing symptoms, and perceived dryness. Patient-reported outcomes will also be assessed at week 12 to evaluate maintenance of treatment effects.
Official title: Effectiveness of an Oral Exercise Program for Xerostomia in Patients With Sjögren Disease: A Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
56
Start Date
2026-10-26
Completion Date
2028-09-30
Last Updated
2026-10-08
Healthy Volunteers
No
Conditions
Interventions
Oral exercise
The oral exercise program will consist of a series of simple oral motor exercises involving coordinated movements of the jaw, lips, cheeks, and tongue. The program was developed based on previously published oral exercise protocols in older adults and patients with xerostomia, with modifications for patients with SjD.