Temporomandibular Joint Dysfunction in Sjögren's Syndrome

NCT07248306 | Completed

• 2 other identifiers: Pamukkale UPamukkale University
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

Study Purpose The purpose of this observational study is to determine the prevalence of temporomandibular dysfunction (TMD) in individuals diagnosed with Sjögren's syndrome and to examine the relationship between disease activity and TMD. The main question to be answered is: Is TMD more common in individuals with Sjögren's syndrome, and is there a relationship between disease activity and TMD? Method Participants diagnosed with Sjögren's syndrome will be evaluated. The prevalence and severity of TMD will be examined along with mouth opening, head posture, and oral health parameters.

Conditions

Sjogren Syndrome

Keywords

Sjogren syndrome; temporamandibular joint

Outcome Measures

Primary Outcomes (2)

• Fonseca Anamnestic Index (FAI)

  Assesses the severity of TMD. As the score increases, the TMD severity (none, mild, moderate, severe) worsens. (0-15: None, 20-45: Mild, 50-65: Moderate, 70-100: Severe)

  Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

• EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI)

  Evaluates disease activity. A high score (5 and above) indicates high disease activity. (The higher the average score, the more severe the symptoms of fatigue, pain, and dryness.)

  Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

Secondary Outcomes (3)

• Xerostomia Inventory

  Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

• Oral Health-Related Quality of Life - UK Scale

  Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

• Visual Analog Scale (VAS) for Disease Involvement

  Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

Study Arms (1)

Group I

patients with primary Sjögren syndrome (pSS)

Diagnostic Test: Temporomandibular Joint Function

Interventions

Temporomandibular Joint Function DIAGNOSTIC_TEST

Temporomandibular joint function and predictive parameters in patients with primary Sjögren Syndrome (pSS)

Group I

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Woman
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Women with Sjögren's Syndrome

You may qualify if:

• Must be volunteers willing to participate in the study.

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University

Pamukkale, Denizli, 20000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sjogren's Syndrome

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; 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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 25, 2025
• Study Start: May 15, 2025
• Primary Completion: August 15, 2025
• Study Completion: September 15, 2025
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)