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Temporomandibular Joint Dysfunction in Sjögren's Syndrome

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07248306
Acronym
Sjögren
Enrollment
27
Registered
2025-11-25
Start date
2025-05-15
Completion date
2025-09-15
Last updated
2025-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sjogren Syndrome

Keywords

Sjogren syndrome, temporamandibular joint

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.

Interventions

DIAGNOSTIC_TESTTemporomandibular Joint Function

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

Sponsors

Pamukkale University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

-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.

Design outcomes

Primary

MeasureTime frameDescription
Fonseca Anamnestic Index (FAI)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)
EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI)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

MeasureTime frameDescription
Visual Analog Scale (VAS) for Disease InvolvementEvaluations 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.
Xerostomia InventoryEvaluations 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.
Oral Health-Related Quality of Life - UK ScaleEvaluations 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).

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026