Temporomandibular Joint Dysfunction in Sjögren's Syndrome (Sjögren)

Investigation of Temporomandibular Joint Function and Related Factors in Patients With Primary Sjögren's Syndrome

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.

Study Overview

• Status: Completed
• Conditions: Sjogren Syndrome
• Intervention / Treatment: Diagnostic test: Temporomandibular Joint Function

• Study Type: Observational
• Enrollment (Actual): 27

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Denizli
    • Pamukkale, Denizli, Turkey (Türkiye), 20000
      • Pamukkale University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Women with Sjögren's Syndrome

Description

-Inclusion Criteria Individuals between 18 and 65 years of age. Must have a confirmed diagnosis of Sjögren's Syndrome. Must possess the mental capacity and education to understand the significance of the research.

Must be volunteers willing to participate in the study.

-Exclusion Criteria Incomplete questionnaires/scales. History of orthodontic treatment within the last six months. Presence of neurological or cognitive deficit. Patients with a history of pathology related to the temporomandibular joint (TMJ) and associated structures prior to the diagnosis of Sjögren's Syndrome.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group I; patients with primary Sjögren syndrome (pSS)	Diagnostic test: Temporomandibular Joint Function; Temporomandibular joint function and predictive parameters in patients with primary Sjögren Syndrome (pSS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Xerostomia Inventory	Measures the severity of dry mouth (xerostomia) symptoms. A higher score indicates more severe xerostomia symptoms.	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	Assesses oral health-related quality of life. An increase in score generally indicates a greater deterioration in quality of life (i.e., worse oral health impact).	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	Numerically evaluates the severity of specific symptoms like dry mouth, dry eyes, facial skin dryness, and lip dryness. As the score approaches 10, the severity of dryness reaches its highest level.	Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

Collaborators and Investigators

• Sponsor: Pamukkale University

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2025
• Primary Completion (Actual): August 15, 2025
• Study Completion (Actual): September 15, 2025

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: November 18, 2025
• First Posted (Actual): November 25, 2025

Study Record Updates

• Last Update Posted (Actual): November 25, 2025
• Last Update Submitted That Met QC Criteria: November 18, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Sjogren syndrome; temporamandibular joint
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Mouth Diseases; Stomatognathic Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Eye Diseases; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Skin and Connective Tissue Diseases; Sjogren's Syndrome
• Other Study ID Numbers: Pamukkale U; Pamukkale University (Registry Identifier: Pamukkale University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No