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NCT Number: NCT07248306

Temporomandibular Joint Dysfunction in 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.

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Key information

Conditions

Sjogren Syndrome Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Dry Eye Syndromes Eye Diseases Immune System Diseases Joint Diseases Lacrimal Apparatus Diseases Mouth Diseases Musculoskeletal Diseases Rheumatic Diseases Salivary Gland Diseases Sjogren's Syndrome Skin and Connective Tissue Diseases Stomatognathic Diseases Xerostomia

Age range

18 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Pamukkale University

Pamukkale, Denizli, 20000, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

-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.

Treatment and study plan

Temporomandibular Joint Function

Diagnostic Test

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

Primary outcomes

  1. Fonseca Anamnestic Index (FAI)

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

    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)

  2. EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI)

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

    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.)

Secondary outcomes

  1. Xerostomia Inventory

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

    Measures the severity of dry mouth (xerostomia) symptoms. A higher score indicates more severe xerostomia symptoms.

  2. Oral Health-Related Quality of Life - UK Scale

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

    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).

  3. Visual Analog Scale (VAS) for Disease Involvement

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

    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.

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Registry information

Official study title

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

Acronym: Sjögren

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Nov 25, 2025
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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