An interventional study of Oral exercise in Sjogren Syndrome, sponsored by Nazli Elif Nacar. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by Nazli Elif Nacar · Not applicable, Interventional, and Treatment
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.
Sjögren disease (SjD) is a chronic systemic autoimmune disease characterized by lymphocytic infiltration of the exocrine glands, resulting in salivary and lacrimal gland dysfunction. Dry mouth resulting from salivary gland hypofunction is one of the most common and burdensome manifestations of the disease. Salivary gland hypofunction contributes to chronic xerostomia, impaired oral comfort, difficulties in speaking and swallowing, alterations in taste perception, and reduced oral health-related quality of life.
Although dry mouth has been considered a consequence of immune-mediated salivary gland destruction, accumulating evidence suggests that glandular pathology alone cannot fully explain the severity of symptoms experienced by patients. The degree of exocrine gland destruction correlates only weakly with glandular function, and objective measures of salivary secretion do not consistently correspond with patients' subjective perception of oral dryness. These findings suggest that the symptoms experienced by patients cannot be explained solely by immune-mediated glandular destruction, indicating that additional mechanisms may contribute to xerostomia in SjD.
Current management of xerostomia in SjD includes saliva substitutes, chewing gum, systemic sialogogues, acupuncture, and electrical stimulation. However, current evidence supporting non-pharmacological interventions remains limited, and no specific intervention can currently be recommended with confidence because of the low quality and heterogeneity of the available studies. Consequently, there remains an unmet need for safe, accessible, and evidence-based non-pharmacological interventions for xerostomia in SjD.
Structured oral exercise programs have shown potential benefits for salivary secretion, oral motor function, and xerostomia symptoms in other populations, including older adults and individuals with radiation-induced xerostomia. Repeated oral motor activity may stimulate salivary secretion through mechanical and sensorimotor stimulation of the oral cavity. However, whether structured oral exercises improve xerostomia-related outcomes in patients with SjD remains unknown.
Therefore, the primary aim of this randomized controlled trial is to investigate whether a structured oral exercise programme, in addition to oral hygiene education and usual medical care, reduces xerostomia severity. Secondary aims are to evaluate its effects on salivary flow, oral health-related quality of life, and swallowing symptoms.
371 studies on the registry are indexed under Sjogren's Syndrome; 104 are open to participants now.
This study's planned enrollment of 56 is above the median of 50 across 244 interventional studies indexed under Sjogren's Syndrome.
Browse Sjogren's Syndrome studies →This is the only study on the registry with Nazli Elif Nacar as lead sponsor.
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Participants in the experimental group will subsequently perform the exercises at home twice daily for six weeks. Written instructions and illustrated exercise sheets will be provided to facilitate adherence. The participants will be provided with an exercise diary to record exercise adherence throughout the intervention period. Participants will receive a weekly telephone call from the physiotherapist to encourage adherence and answer any questions regarding the exercise program. The oral exercise program will consist of a series of simple oral motor exercises involving coordinated movements of the jaw, lips, cheeks, and tongue.
Other: Oral exercise
Both groups will receive standardized oral hygiene education. All participants will be instructed to continue their usual medical treatment throughout the study period without changing medication unless clinically indicated.
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.
Xerostomia Inventory (XI)
The XI is a patient-reported assessment tool designed to evaluate the sensation of dry mouth. It consists of 11 items using a 5-point Likert scale, with each item scored from 1 (never) to 5 (very frequently). The total score ranges from 11 to 55, with higher scores indicating a more severe level of dry mouth.
Time frame: baseline, week 6, week 12
EULAR Primary Sjögren's Syndrome Patient-Reported Index (ESSPRI)
ESSPRI was developed to assess-based on patient self-reporting-the symptoms of dryness, fatigue, and pain experienced by individuals with pSS over the preceding two weeks. These three symptoms are evaluated individually, with the severity of each rated on a scale from 0 (absent) to 10 (most severe). Individuals are asked to score the severity of their symptoms within this range. The total score is calculated by averaging the component scores. An ESSPRI score below 5 is considered an acceptable disease state, whereas a score of 5 or higher is regarded as an indication of high disease activity.
Time frame: baseline, week 6, week 12
Dryness severity
The severity of perceived mouth, eye, and nose dryness will be assessed using a 100-mm Visual Analogue Scale (VAS); over the preceding two weeks.
Time frame: baseline, week 6, week 12
unstimulated whole salivary flow rate
Unstimulated whole saliva will be collected for 5 minutes. Participants will continuously expectorate the accumulated whole saliva into a pre-weighed collection tube without swallowing
Time frame: baseline, week 6
stimulated whole salivary flow rate
Stimulated whole saliva will be collected for 5 minutes using a standardised citric acid stimulation procedure. A cotton-tipped applicator soaked in 2% citric acid will be applied to the lateral borders of the tongue at the beginning of the collection and reapplied every 60 seconds. Participants will continuously expectorate the accumulated whole saliva into a pre-weighed collection tube without swallowing
Time frame: baseline, immediately post-first exercise session, week 6
Oral Health Impact Profile-14
Oral health will be evaluated with OHIP-14 using a 5-point Likert scale (ranging from "4=very often" to "0=never"). The total score obtained by totaling the item for the 14 items at the same frequency; the total score ranged from 0 to 56.
Time frame: baseline, week 6, week 12
Eating Assessment Tool-10
The EAT-10 is a self-report assessment tool used to identify individuals at high risk for swallowing disorders. It consists of 10 items, each scored on a five-point Likert-type scale ranging from 0 (no problem) to 4 (severe problem). A score of three or higher on the EAT-10 indicates the possible presence of dysphagia.
Time frame: baseline, week 6, week 12
Global Rating of Change scale
Participants' perceived change in oral dryness will also be evaluated using a Global Rating of Change scale. (much better, a little better, no change, a little worse, much worse).
Time frame: week 6, week 12
No study locations are listed for this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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