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NCT06897722Active, not recruiting

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

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.

Source: ClinicalTrials.gov · Last updated 27 Mar 2025

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
100 (actual)
First submitted
20 Mar 2025
Start date
4 Nov 2024
Primary completion date
3 Mar 2025
Lead sponsor
Zhala Vatankha Sain
Diseases
Psoriasis
NCT number
NCT06897722

What you commit to

  • Study type: Observational
  • Participants enrolled: 100
  • From 4 Nov 2024 to the primary completion date, 3 Mar 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Use of antibiotics, corticosteroids, or immunosuppressive drugs within the last 3 months.

Other illness

  • Diagnosis of any systemic inflammatory disease other than psoriasis, such as rheumatoid arthritis, inflammatory bowel disease, or systemic lupus erythematosus.
  • History of malignancy or chemotherapy/radiotherapy treatment.
  • History of substance abuse or chronic alcohol consumption.
  • Presence of acute infections, including oral or systemic infections.

Age

  • Age below 25 or above 65 years.

Other

  • Pregnant or lactating women.
  • Current smokers or individuals who have smoked within the last year.
  • Refusal to sign the informed consent form or inability to comply with the study protocol

Who the study is looking for

  • Age between 25 and 65 years.
  • Confirmed diagnosis of chronic plaque psoriasis (for PS+G, PS+P group) by a board-certified dermatologist.
  • Diagnosis of Gingivitis and Stage II or III, Grade B or C periodontitis (for P and PS+P groups) based on the 2017 World Workshop on the Classification of Periodontal Diseases and Conditions.
  • At least 20 remaining teeth.
  • No history of systemic conditions that could affect periodontal health, such as diabetes mellitus, autoimmune diseases, or cardiovascular diseases.
  • No prior periodontal treatment within the last 6 months.
  • No use of antibiotics, anti-inflammatory medications, or immunosuppressive drugs in the last 3 months.
  • Non-smokers or those who have not smoked in the past year.
  • Willingness to participate voluntarily and provide written informed consent.

Age in the registry: 25 years to 65 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Akdeniz University Faculty of Dentistry, Akdeniz University Hospital
Coordinator of this site? Confirm its status
AntalyaTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.