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

NCT06530940 | Not Yet Recruiting

• 1 other identifier: XERODIAG
• Study Type: observational
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Sjogren's Syndrome; Xerostomia; Diagnosis

Keywords

xerostomia; sjogren's syndrom; salivary flow; oral schirmer test

Outcome Measures

Primary Outcomes (4)

• Sensitivity

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

  30 minutes

• Specificity

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

  30 minutes

• Positive predictive value

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

  30 minutes

• Negative predictive value

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

  90 minutes

Study Arms (2)

Group 1

consisting of 90 patients with SS and confirmed xerostomia by SF measurement (\<0.1 ml/minute).

Diagnostic Test: Buccal Schirmer Test

Group 2

consisting of 90 patients with SS and normal SF (≥0.1 ml/minute).

Diagnostic Test: Buccal Schirmer Test

Interventions

Buccal Schirmer Test DIAGNOSTIC_TEST

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

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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

You may qualify if:

• Included patients meet the following criteria:
• age over 18 years
• diagnosis of Sjogren's syndrome meeting the ACR/EULAR 2016 criteria.

You may not qualify if:

• These include:
• Cognitive or dementia disorders
• Pregnancy

Sponsors & Collaborators

• University Tunis El Manar: lead

MeSH Terms

Conditions

Sjogren's Syndrome; Xerostomia; Disease

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Fatma Saïd

  Centre Hospitalo-Universitaire La Rabta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fatma Saïd, MD

CONTACT

0021671150876; fatma.said@fmt.utm.tn

Fatma Saïd

CONTACT

saidzribifatma@yahoo.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: July 28, 2024
• First Posted: July 31, 2024
• Study Start: August 19, 2024
• Primary Completion: November 30, 2024
• Study Completion: December 31, 2024
• Last Updated: August 2, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share