Clinical Trial

Diagnostic Interest of the Buccal Schirmer Test in Xerostomia During Sjögren's Syndrome: XERODIAG

Study acronym: XERODIAG
Unknown
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Record status
This record was last updated August 2, 2024 (before its estimated November 30, 2024 completion). Its status may not reflect the trial's current state.
Summary
Xerostomia is a common and very bothersome manifestation that impairs the quality of life in Sjogren's syndrome. Its diagnosis mainly relies on the measurement of salivary flow (SF). Performing this test is unpleasant for the patient, lacks precision, can be influenced by certain conditions, and requires good patient cooperation. Other alternatives such as the buccal Schirmer test can be used. The aim of this study is to demonstrate the non-inferiority of the buccal Schirmer test compared to SF measurement. This is a diagnostic study comparing a group of patients (n=90) with Sjogren's syndrome (SS) and normal SF (≥0.1 ml/minute) to a group of patients with SS and decreased SF (\<0.1 ml/minute).
Protocol Amendment History 1 change
critical Trial status changed: Not Yet Recruiting → Unknown 2026-08-02
Trial Details
NCT Number NCT06530940
Lead Sponsor University Tunis El Manar
Conditions Sjogren's Syndrome, Xerostomia, Diagnosis
Enrollment 180 participants
Start Date 2024-08-19
Primary Completion 2024-11-30 (estimated)
Study Completion 2024-12-31 (estimated)
Updated on ClinicalTrials.gov 2024-08-02