Effectiveness of an Oral Exercise Program for Xerostomia in Patients With Sjögren Disease
ConditionSjogren Syndrome
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNazli Elif Nacar
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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);
Disqualifiers
history of head and neck radiotherapy,
severe cognitive impairment (i.e., dementia)
psychiatric disorders preventing participation,
neurological disorders affecting oral motor function,
Trial design
Design model
Parallel
Treatments tested in this trial
Oral exercise
Other interventionThe 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.
Treatment groups
56 Participants
are divided into 2 treatment groupsGroup A: Experimental groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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 12Secondary outcomes
1
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 122
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 123
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 64
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 6Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Nazli Elif Nacar
Lead sponsor
Kahramanmaras Sutcu Imam University
Sponsor institution
Source ClinicalTrials.gov
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