NCT07864987Not yet recruiting
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
Source: ClinicalTrials.gov · Last updated 8 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 56 (estimated)
- First submitted
- 25 Sept 2026
- Start date
- 26 Oct 2026
- Primary completion date
- 30 Jun 2028
- Lead sponsor
- Nazli Elif Nacar
- Diseases
- Sjögren's disease
- NCT number
- NCT07864987
What you commit to
- Study type: Interventional
- Planned participants: 56
- From 26 Oct 2026 to the primary completion date, 30 Jun 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- participation in structured oral motor or swallowing rehabilitation within the previous 2 months,
Other illness
- history of head and neck radiotherapy,
- severe cognitive impairment (i.e., dementia)
- psychiatric disorders preventing participation,
- neurological disorders affecting oral motor function,
Other
- inability or unwillingness to comply with the study protocol.
Who the study is looking for
- a diagnosis of SjD based on the 2016 ACR/EULAR Classification Criteria;
- ≥18 years of age;
- residual stimulated whole salivary flow rate (≥0.05 ml/min);
- presence of subjective xerostomia (Visual Analogue Scale ≥ 50);
- stable pharmacological treatment for at least 4 weeks before enrolment;
- provision of written informed consent. -
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.