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

NCT06897722 | Active Not Recruiting

• 1 other identifier: AkdenizU Organization
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Psoriasis; Periodontitis; GCF; TNF-α; IL-17A; YKL-40; Serum Markers

Outcome Measures

Primary Outcomes (7)

• TNF-α levels in gingival crevicular fluid (GCF)

  Levels of TNF-α will be measured using ELISA in GCF samples collected at baseline.

  At baseline (single visit)

• TNF-α levels in serum

  Levels of TNF-α will be measured using ELISA in serum samples collected at baseline.

  At baseline (single visit).

• IL-17A levels in gingival crevicular fluid (GCF)

  Levels of İL-17A will be measured using ELISA in serum samples collected at baseline.

  At baseline (single visit).

• IL-17A levels in serum

  Levels of IL-17A will be measured using ELISA in GCF samples collected at baseline.

  At baseline (single visit).

• YKL-40 levels in gingival crevicular fluid (GCF)

  Levels of YKL-40 will be measured using ELISA in GCF samples collected at baseline.

  At baseline (single visit).

• YKL-40 levels in serum

  Levels of TNF-α will be measured using ELISA in serum samples collected at baseline.

  At baseline (single visit).

• Periodontal assesment

  Probing Pocket Depth (PPD), Clinical Attachment Level (CAL), Bleeding on Probing (BOP), Plaque Index (PI) collected at baseline.

  At baseline (single visit)

Study Arms (5)

1 group : Control (C)

1 group : Control (C): Healthy individuals without psoriasis, gingivitis or periodontitis.

Diagnostic Test: TNF-α analysis in GCF; Diagnostic Test: IL-17A analysis in GCF; Diagnostic Test: YKL-40 analysis in GCF; Diagnostic Test: TNF-α analysis in Serum; Diagnostic Test: İL-17A analysis in Serum; Diagnostic Test: YKL-40 analysis in Serum; Diagnostic Test: Periodontal assesment

2. group Gingivitis (G)

Gingivitis (G): Individuals diagnosed with gingivitis but without psoriasis.

Diagnostic Test: TNF-α analysis in GCF; Diagnostic Test: IL-17A analysis in GCF; Diagnostic Test: YKL-40 analysis in GCF; Diagnostic Test: TNF-α analysis in Serum; Diagnostic Test: İL-17A analysis in Serum; Diagnostic Test: YKL-40 analysis in Serum; Diagnostic Test: Periodontal assesment

3. group Periodontitis (P)

3\. group Periodontitis (P): Individuals diagnosed with periodontitis but without psoriasis.

Diagnostic Test: TNF-α analysis in GCF; Diagnostic Test: IL-17A analysis in GCF; Diagnostic Test: YKL-40 analysis in GCF; Diagnostic Test: TNF-α analysis in Serum; Diagnostic Test: İL-17A analysis in Serum; Diagnostic Test: YKL-40 analysis in Serum; Diagnostic Test: Periodontal assesment

4. group Psoriasis with gingivitis (PS+G)

4\. group Psoriasis with gingivitis (PS+G): Individuals diagnosed with gingivitis and psoriasis.

Diagnostic Test: TNF-α analysis in GCF; Diagnostic Test: IL-17A analysis in GCF; Diagnostic Test: YKL-40 analysis in GCF; Diagnostic Test: TNF-α analysis in Serum; Diagnostic Test: İL-17A analysis in Serum; Diagnostic Test: YKL-40 analysis in Serum; Diagnostic Test: Periodontal assesment

5. group Psoriasis with Periodontitis (PS+P)

5\. group Psoriasis with Periodontitis (PS+P): Individuals diagnosed with psoriasis and periodontitis.

Diagnostic Test: TNF-α analysis in GCF; Diagnostic Test: IL-17A analysis in GCF; Diagnostic Test: YKL-40 analysis in GCF; Diagnostic Test: TNF-α analysis in Serum; Diagnostic Test: İL-17A analysis in Serum; Diagnostic Test: YKL-40 analysis in Serum; Diagnostic Test: Periodontal assesment

Interventions

TNF-α analysis in GCF DIAGNOSTIC_TEST

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.

1 group : Control (C); 2. group Gingivitis (G); 3. group Periodontitis (P); 4. group Psoriasis with gingivitis (PS+G); 5. group Psoriasis with Periodontitis (PS+P)

IL-17A analysis in GCF DIAGNOSTIC_TEST

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.

1 group : Control (C); 2. group Gingivitis (G); 3. group Periodontitis (P); 4. group Psoriasis with gingivitis (PS+G); 5. group Psoriasis with Periodontitis (PS+P)

YKL-40 analysis in GCF DIAGNOSTIC_TEST

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.

1 group : Control (C); 2. group Gingivitis (G); 3. group Periodontitis (P); 4. group Psoriasis with gingivitis (PS+G); 5. group Psoriasis with Periodontitis (PS+P)

TNF-α analysis in Serum DIAGNOSTIC_TEST

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.

1 group : Control (C); 2. group Gingivitis (G); 3. group Periodontitis (P); 4. group Psoriasis with gingivitis (PS+G); 5. group Psoriasis with Periodontitis (PS+P)

İL-17A analysis in Serum DIAGNOSTIC_TEST

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.

1 group : Control (C); 2. group Gingivitis (G); 3. group Periodontitis (P); 4. group Psoriasis with gingivitis (PS+G); 5. group Psoriasis with Periodontitis (PS+P)

YKL-40 analysis in Serum DIAGNOSTIC_TEST

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.

1 group : Control (C); 2. group Gingivitis (G); 3. group Periodontitis (P); 4. group Psoriasis with gingivitis (PS+G); 5. group Psoriasis with Periodontitis (PS+P)

Periodontal assesment DIAGNOSTIC_TEST

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

1 group : Control (C); 2. group Gingivitis (G); 3. group Periodontitis (P); 4. group Psoriasis with gingivitis (PS+G); 5. group Psoriasis with Periodontitis (PS+P)

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study includes 100 participants from Akdeniz University, Turkey, categorized into five groups (n=20 each): Control (C): Healthy individuals without psoriasis or periodontitis, Gingivitis (G): Individuals diagnosed with gingivitis but without psoriasis, Periodontitis (P): Individuals with Stage II/III, Grade B/C 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. Participants are 25-65 years old, non-smokers, with at least 20 teeth, and no systemic conditions affecting periodontal health. Psoriasis diagnoses are confirmed by a board-certified dermatologist; gingivitis and periodontitis is diagnosed per 2017 classification criteria. This study analyzes TNF-α, IL-17A, and YKL-40 levels in serum and gingival crevicular fluid (GCF) to explore the immunoinflammatory link between psoriasis and periodontitis.

You may qualify if:

• 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.

You may not qualify if:

• Age below 25 or above 65 years.
• 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.
• Use of antibiotics, corticosteroids, or immunosuppressive drugs within the last 3 months.
• Pregnant or lactating women.
• Current smokers or individuals who have smoked within the last year.
• History of substance abuse or chronic alcohol consumption.
• Presence of acute infections, including oral or systemic infections.
• Refusal to sign the informed consent form or inability to comply with the study protocol

Sponsors & Collaborators

• Zhala Vatankha Sain: lead

Study Sites (1)

Akdeniz University Faculty of Dentistry, Akdeniz University Hospital

Antalya, Antalya, 07070, Turkey (Türkiye)

Location

Related Publications (7)

• Kong Y, Zhang S, Su X, Peng D, Su Y. Serum levels of YKL-40 are increased in patients with psoriasis: a meta-analysis. Postgrad Med. 2019 Aug;131(6):405-412. doi: 10.1080/00325481.2019.1643634. Epub 2019 Jul 22.

  PMID: 31298974 BACKGROUND

• Zhang X, Gu H, Xie S, Su Y. Periodontitis in patients with psoriasis: A systematic review and meta-analysis. Oral Dis. 2022 Jan;28(1):33-43. doi: 10.1111/odi.13617. Epub 2020 Sep 18.

  PMID: 32852860 BACKGROUND

• Mendes VS, Cota LOM, Costa AA, Oliveira AMSD, Costa FO. Periodontitis as another comorbidity associated with psoriasis: A case-control study. J Periodontol. 2019 Apr;90(4):358-366. doi: 10.1002/JPER.18-0394. Epub 2018 Nov 28.

  PMID: 30387155 BACKGROUND

• Armstrong AW, Puig L, Joshi A, Skup M, Williams D, Li J, Betts KA, Augustin M. Comparison of Biologics and Oral Treatments for Plaque Psoriasis: A Meta-analysis. JAMA Dermatol. 2020 Mar 1;156(3):258-269. doi: 10.1001/jamadermatol.2019.4029.

  PMID: 32022825 BACKGROUND

• Marruganti C, Gaeta C, Falciani C, Cinotti E, Rubegni P, Alovisi M, Scotti N, Baldi A, Bellan C, Defraia C, Fiorino F, Valensin S, Bellini E, De Rosa A, D'Aiuto F, Grandini S. Are periodontitis and psoriasis associated? A pre-clinical murine model. J Clin Periodontol. 2024 Aug;51(8):1044-1053. doi: 10.1111/jcpe.13996. Epub 2024 May 3.

  PMID: 38699834 BACKGROUND

• Gorska R, Gregorek H, Kowalski J, Laskus-Perendyk A, Syczewska M, Madalinski K. Relationship between clinical parameters and cytokine profiles in inflamed gingival tissue and serum samples from patients with chronic periodontitis. J Clin Periodontol. 2003 Dec;30(12):1046-52. doi: 10.1046/j.0303-6979.2003.00425.x.

  PMID: 15002890 BACKGROUND

• Jimenez C, Carvajal D, Hernandez M, Valenzuela F, Astorga J, Fernandez A. Levels of the interleukins 17A, 22, and 23 and the S100 protein family in the gingival crevicular fluid of psoriatic patients with or without periodontitis. An Bras Dermatol. 2021 Mar-Apr;96(2):163-170. doi: 10.1016/j.abd.2020.08.008. Epub 2021 Jan 25.

  PMID: 33531183 BACKGROUND

MeSH Terms

Conditions

Psoriasis; Periodontal Diseases; Periodontitis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Zhala Vatankha Sain, DDS

  Akdeniz University, Faculty of Dentistry, Department of Periodontology

  PRINCIPAL INVESTIGATOR

• Kemal Üstün, Prof.

  Akdeniz University, Faculty of Dentistry, Department of Periodontology

  STUDY CHAIR

• Özlem Daltaban, Assoc. Prof.

  Akdeniz University, Faculty of Dentistry, Department of Periodontology

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Researcher, Department of Periodontology, Akdeniz University

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: March 27, 2025
• Study Start: November 4, 2024
• Primary Completion: March 3, 2025
• Study Completion: April 1, 2025
• Last Updated: March 27, 2025

Record last verified: 2024-11

Locations

TU (1)