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NCT06897722

Evaluation of TNF-α, IL-17A, and YKL-40 in GCF and Serum of Psoriasis Patients and Healthy Controls

Sponsor: Zhala Vatankha Sain

View on ClinicalTrials.gov

Summary

Background: Psoriasis is a chronic inflammatory skin disease that affects 2-3% of the global population and is linked to immune dysregulation and systemic inflammation. Periodontitis, a chronic inflammatory gum disease, leads to the destruction of gum tissues and bone. Both conditions share common inflammatory pathways, with key immune mediators such as tumor necrosis factor-alpha (TNF-α), interleukin-17A (IL-17A), and YKL-40 playing a role in tissue destruction and disease progression. However, the biological mechanisms linking psoriasis and periodontitis remain unclear, and few studies have examined localized inflammatory responses in the gums of psoriasis patients. Objectives and Methods: This study aims to evaluate the relationship between psoriasis and periodontitis by measuring TNF-α, IL-17A, and YKL-40 levels in both gingival crevicular fluid (GCF) and serum. A total of 100 participants will be recruited and categorized into three groups: Control (C): Healthy individuals without psoriasis or periodontitis. Gingivitis (G): Individuals diagnosed with gingivitis but without psoriasis. Periodontitis (P): Individuals diagnosed with periodontitis but without psoriasis. Psoriasis with gingivitis (PS+G): Individuals diagnosed with gingivitis but without psoriasis. Psoriasis with Periodontitis (PS+P): Individuals with both psoriasis and periodontitis. All participants will undergo periodontal examinations, including plaque index (PI), bleeding on probing (BOP), probing pocket depth (PPD), and clinical attachment level (CAL). GCF and blood samples will be collected, and biomarker levels will be analyzed using enzyme-linked immunosorbent assay (ELISA). Expected Outcomes and Clinical Relevance: The study will investigate whether systemic inflammation in psoriasis contributes to periodontal disease progression. If psoriasis patients show higher inflammatory biomarker levels, it may suggest a shared immunopathogenic mechanism. The results may contribute to: Early detection strategies for periodontitis in psoriasis patients. Targeted anti-inflammatory therapies for both conditions. Interdisciplinary collaboration between dermatologists and periodontists for better management. This study is the first to evaluate TNF-α and YKL-40 in the GCF of psoriasis patients, filling a critical gap in the literature regarding localized immune responses. The results could also help identify potential biomarkers that may be useful for monitoring disease progression and treatment responses in psoriasis and periodontitis patients. Conclusion: By investigating the inflammatory relationship between psoriasis and periodontitis, this study aims to uncover new insights into the immune system's role in chronic inflammatory diseases. Understanding these mechanisms could lead to improved diagnostic tools, prevention strategies, and personalized treatment approaches for patients affected by both conditions.

Official title: Psoriasis and Periodontitis Are Chronic Inflammatory Diseases Characterized by Immune Dysregulation and Systemic Inflammatory Burden. Both Conditions Share Key Inflammatory Mediators, Including Tumor Necrosis Factor-alpha (TNF-α), Interleukin-17A (IL-17A), and YKL-40, Which Contribute to Tissue Destruction and Disease Progression. This Study Aimed to Investigate the Association Between Psoriasis and Periodontal Diseases by Evaluating Clinical Periodontal Parameters and Measuring TNF-α, IL-17A, and YKL-40 Levels in Gingival Crevicular Fluid (GCF) and Serum.

Key Details

Gender

All

Age Range

25 Years - 65 Years

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2024-11-04

Completion Date

2025-04

Last Updated

2025-03-27

Healthy Volunteers

Yes

Interventions

DIAGNOSTIC_TEST

TNF-α analysis in GCF

The primary intervention will involve the non-invasive collection of GCF samples using Periopaper strips. The strips will be placed into the gingival sulcus for 30 seconds and then stored at -80°C until analysis. The analysis of TNF-α levels in gingival crevicular fluid (GCF) will be performed using ELISA.

DIAGNOSTIC_TEST

IL-17A analysis in GCF

The primary intervention involves the non-invasive collection of GCF samples using periopaper strips. Periopaper strips are placed into the gingival sulcus for 30 seconds, then stored at -80°C until analysis. Analysis of TNF-α levels in gingival crevicular fluid (GCF) will be performed using ELISA.

DIAGNOSTIC_TEST

YKL-40 analysis in GCF

The primary intervention involves the non-invasive collection of GCF samples using periopaper strips. Periopaper strips are placed into the gingival sulcus for 30 seconds, then stored at -80°C until analysis. Analysis of TNF-α levels in gingival crevicular fluid (GCF) will be performed using ELISA.

DIAGNOSTIC_TEST

TNF-α analysis in Serum

The intervention will involve venous blood collection for serum analysis. Venous blood will be drawn, allowed to clot, will be centrifuged at 3,000 rpm for 10 minutes, and will be stored at -80°C until analysis.

DIAGNOSTIC_TEST

İL-17A analysis in Serum

The intervention will involve venous blood collection for serum analysis. Venous blood will be drawn, allowed to clot, will be centrifuged at 3,000 rpm for 10 minutes, and will be stored at -80°C until analysis.

DIAGNOSTIC_TEST

YKL-40 analysis in Serum

The intervention will involve venous blood collection for serum analysis. Venous blood will be drawn, allowed to clot, will be centrifuged at 3,000 rpm for 10 minutes, and will be stored at -80°C until analysis.

DIAGNOSTIC_TEST

Periodontal assesment

Comprehensive periodontal assessments will be conducted, including Plaque Index (PI), Bleeding on Probing (BOP), Probing Pocket Depth (PPD), and Clinical Attachment Level (CAL).

Locations (1)

Akdeniz University Faculty of Dentistry, Akdeniz University Hospital

Antalya, Antalya, Turkey (Türkiye)