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

NCT06897722 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2025-03-27

No results posted yet for this study

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.

Conditions

  • Psoriasis (PsO)
  • Periodontal Disease

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).

Sponsors & Collaborators

  • Zhala Vatankha Sain

    lead OTHER

Principal Investigators

  • Zhala Vatankha Sain, DDS · Akdeniz University, Faculty of Dentistry, Department of Periodontology

  • Kemal Üstün, Prof. · Akdeniz University, Faculty of Dentistry, Department of Periodontology

  • Özlem Daltaban, Assoc. Prof. · Akdeniz University, Faculty of Dentistry, Department of Periodontology

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-04
Primary Completion
2025-03-03
Completion
2025-04-30

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06897722 on ClinicalTrials.gov