Xerostomia
Conditions
Interventions
Gold Standard:For participants with pathologically confirmed pSS: They must have clinical symptoms of dry mouth and meet the 2016 pSS diagnostic criteria set by the American College of Rheumatology (A
Index test:Ultrasound shear wave elastography
Sponsors
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Participants must be informed about the entire trial process, voluntarily agree to participate, and sign an informed consent form; 2.They must be aged >=18 years and <=75 years; 3.For suspected preclinical xerostomia participants: (1) They must have experienced symptoms of dry mouth for more than 3 months; (2) They must test negative for autoantibodies (SSA, SSB, RO52); (3) Their total score on the Xerostomia Inventory (XI) must be 6 or higher out of 10; 4.For participants with pathologically confirmed pSS: They must have clinical symptoms of dry mouth and meet the 2016 pSS diagnostic criteria set by the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR).
Exclusion criteria
Exclusion criteria: 1.Patients with severe hypertension, diabetes, or systemic rheumatic immune diseases; 2.Those taking medications that may cause dry mouth (e.g., furosemide); 3.Patients who have undergone radiotherapy for head and neck malignancies or chemotherapy for other systemic malignancies; 4.Pregnant women, those planning to become pregnant, or women who are breastfeeding; 5.Individuals with any other conditions that the researchers deem unsuitable for inclusion in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stiffness of the parotid gland (kPa); | — |
Secondary
| Measure | Time frame |
|---|---|
| Stiffness of the submandibular gland (kPa); | — |
Countries
China
Contacts
Public ContactYiwen Deng
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Outcome results
None listed