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

ConditionsSjogren's SyndromeXerostomiaDiagnosis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorUniversity Tunis El Manar

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

age over 18 years

diagnosis of Sjogren's syndrome meeting the ACR/EULAR 2016 criteria.

Disqualifiers

Cognitive or dementia disorders

Pregnancy

Trial population

Included patients meet the following criteria: * age over 18 years * diagnosis of Sjogren's syndrome meeting the ACR/EULAR 2016 criteria. • Exclusion criteria: These include: * Cognitive or dementia disorders * Pregnancy

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Buccal Schirmer Test

    Diagnostic test

    For each group, we will perform: * SF measurement * Buccal Schirmer test (BST) .

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: Group 11 intervention
Group B: Group 21 intervention

Trial outcomes

Primary outcomes

1

Sensitivity

ratio of the number of patients with SF+ and BST+ by the number of patients with SF+

Time frame
30 minutes
2

Specificity

ratio of the number of patients with BST- and SF- by the number of patients with SF-

Time frame
30 minutes
3

Positive predictive value

ratio of the number of patients with SF+ and BST+ by the number of patients with BST+

Time frame
30 minutes
4

Negative predictive value

ratio of the number of patients with BST- and SF- by the number of patients with BST-

Time frame
90 minutes

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Tunis El Manar

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: