[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659548":3},{"organization":4,"outcomesModule":7,"designInfo":39,"detailedDescription":47,"studyPopulation":38,"armGroups":48,"interventions":59,"overallOfficials":38,"centralContacts":38,"locations":38,"responsibleParty":64,"collaborators":38,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":38,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":38,"enrollmentInfo":77,"targetDuration":38,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":91,"whyStopped":38,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":38},{"fullName":5,"class":6},"Kahramanmaras Sutcu Imam University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":38},[9],{"measure":10,"description":11,"timeFrame":12},"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.","baseline, week 6, week 12",[14,17,20,24,28,31,34],{"measure":15,"description":16,"timeFrame":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.",{"measure":18,"description":19,"timeFrame":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.",{"measure":21,"description":22,"timeFrame":23},"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","baseline, week 6",{"measure":25,"description":26,"timeFrame":27},"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","baseline, immediately post-first exercise session, week 6",{"measure":29,"description":30,"timeFrame":12},"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.",{"measure":32,"description":33,"timeFrame":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.",{"measure":35,"description":36,"timeFrame":37},"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).","week 6, week 12",null,{"allocation":40,"interventionModel":41,"interventionModelDescription":38,"primaryPurpose":42,"observationalModel":38,"timePerspective":38,"maskingInfo":43},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":44,"maskingDescription":38,"whoMasked":45},"SINGLE",[46],"OUTCOMES_ASSESSOR","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.\n\nAlthough 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.\n\nCurrent 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.\n\nStructured 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.\n\nTherefore, 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.",[49,55],{"label":50,"type":51,"description":52,"interventionNames":53},"Experimental group","EXPERIMENTAL","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.\n\nThe oral exercise program will consist of a series of simple oral motor exercises involving coordinated movements of the jaw, lips, cheeks, and tongue.",[54],"Other: Oral exercise",{"label":56,"type":57,"description":58,"interventionNames":38},"Control group","NO_INTERVENTION","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.",[60],{"type":6,"name":61,"description":62,"armGroupLabels":63,"otherNames":38},"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.",[50],{"type":65,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":38,"oldOrganization":38},"SPONSOR_INVESTIGATOR","Nazli Elif Nacar","Assistant Professor","100659548","effectiveness-of-an-oral-exercise-program-for-xerostomia-in-patients-with-sjgren-disease-100659548",false,"NCT07864987","Effectiveness of an Oral Exercise Program for Xerostomia in Patients With Sjögren Disease","Effectiveness of an Oral Exercise Program for Xerostomia in Patients With Sjögren Disease: A Randomized Controlled Trial","Inclusion Criteria:\n\n* a diagnosis of SjD based on the 2016 ACR\u002FEULAR Classification Criteria;\n* ≥18 years of age;\n* residual stimulated whole salivary flow rate (≥0.05 ml\u002Fmin);\n* presence of subjective xerostomia (Visual Analogue Scale ≥ 50);\n* stable pharmacological treatment for at least 4 weeks before enrolment;\n* provision of written informed consent. -\n\nExclusion Criteria:\n\n* history of head and neck radiotherapy,\n* severe cognitive impairment (i.e., dementia)\n* psychiatric disorders preventing participation,\n* neurological disorders affecting oral motor function,\n* participation in structured oral motor or swallowing rehabilitation within the previous 2 months,\n* inability or unwillingness to comply with the study protocol.","ALL","18 Years",{"count":78,"type":79},56,"ESTIMATED","INTERVENTIONAL",[82],"NA","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.\n\nParticipants 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.",[85],"Sjogren Syndrome",[87,88,89,90],"sjogren disease","oral exercise","xerostomia","dry mouth","NOT_YET_RECRUITING","2026-10-02",{"date":94,"type":95},"2026-10-08","ACTUAL",{"date":97,"type":79},"2026-10-26",{"date":99,"type":79},"2028-09-30",{"name":66,"class":6}]