Clinical trials

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.