Schedule of enrolment, interventions and assessments
Timepoint (weeks) | Enrolment | Baseline assessment | Post-intervention assessment | ||||
T-6 | T-4 | T0 | T1 | T2 | T8 | T16 (closeout) | |
Enrolment | |||||||
Eligibility screen | X | ||||||
Informed consent | X | ||||||
Interventions | |||||||
CEUSS | X | ||||||
Assessments | |||||||
Safety | X | X | X | X | |||
Technical feasibility and applicability | X | ||||||
UWSF, SWSF and SPSF | X | X | X | X | X | X | |
Analysis of the salivary cytokine profiles | X | X | X | X | X | ||
CODS | X | X | X | X | X | ||
XI score | X | X | X | X | X | ||
ESSPRI score | X | X | X | X | X | ||
MPQ | X | X | X | X | X | ||
Salivary gland topography | X | X | X |
CEUSS, contrast-enhanced ultrasound sialendoscopy; CODS, Clinical Oral Dryness Score; ESSPRI, European League Against Rheumatism (EULAR) Sjögren’s Syndrome Patient Reported Index; MPQ, McGill Pain Questionnaire; SPSF, stimulated parotid saliva flow; SWSF, stimulated whole mouth saliva flow; T-6, 6 weeks before intervention; UWSF, unstimulated whole mouth saliva flow; XI, Xerostomia Inventory.