Psoriasis (PsO)NCT06897722
Evaluation of TNF-α, IL-17A, and YKL-40 in GCF and Serum of Psoriasis Patients and Healthy Controls
An observational study of Psoriasis (PsO) and Periodontal Disease, run by Zhala Vatankha Sain at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis (PsO), Periodontal Disease
- What is being tested?
- TNF-α analysis in GCF, IL-17A analysis in GCF and YKL-40 analysis in GCF
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Nov 2024to Apr 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Akdeniz University Faculty of Dentistry, Akdeniz University Hospital
Antalya, Antalya, 07070
About this study
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.
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.
Read more
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.
Read the detailed description
Psoriasis and periodontitis are chronic inflammatory diseases that share key immunopathological mechanisms. Psoriasis is primarily a dermatological condition, but it also exhibits systemic inflammatory characteristics that may contribute to comorbidities such as periodontitis. Periodontitis, a chronic immune-inflammatory condition of the supporting structures of the teeth, is similarly characterized by sustained inflammatory responses and tissue destruction.
Emerging evidence suggests that these two diseases may be biologically linked through shared inflammatory pathways. Among the common mediators, tumor necrosis factor-alpha (TNF-α), interleukin-17A (IL-17A), and YKL-40 play prominent roles in the pathogenesis of both conditions. TNF-α contributes to immune activation, tissue breakdown, and bone resorption. IL-17A, associated with Th17-mediated responses, promotes keratinocyte proliferation and inflammatory cell infiltration in psoriasis, while driving extracellular matrix degradation and osteoclastogenesis in periodontitis. YKL-40, a glycoprotein involved in tissue remodeling and inflammation, has been proposed as a potential biomarker for chronic inflammatory diseases, including psoriasis and periodontitis.
While elevated levels of these markers have been individually observed in serum or tissues of patients with either condition, limited data exist on their expression in both systemic and local environments-particularly within the gingival crevicular fluid (GCF) of psoriasis patients. This study will address this gap by assessing TNF-α, IL-17A, and YKL-40 levels in GCF and serum samples of individuals with and without psoriasis and periodontal disease.
Through a cross-sectional, case-control study design, this research aims to investigate whether systemic inflammation associated with psoriasis correlates with increased periodontal inflammation and whether common biomarkers may indicate a shared pathogenic mechanism. Understanding this potential link could lead to improved interdisciplinary management strategies and earlier identification of periodontal risk in patients with psoriasis.
- Conditions
- Psoriasis (PsO), Periodontal Disease
- Being tested
- TNF-α analysis in GCF, IL-17A analysis in GCF, YKL-40 analysis in GCF, TNF-α analysis in Serum, İL-17A analysis in Serum
- Keywords
- Psoriasis, Periodontitis, GCF, TNF-α, IL-17A, YKL-40, Serum Markers
- Medical subject headings
- Psoriasis, Periodontal Diseases, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TNF-α analysis in GCFDiagnostic 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.
IL-17A analysis in GCFDiagnostic 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.
YKL-40 analysis in GCFDiagnostic 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.
TNF-α analysis in SerumDiagnostic 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.
İL-17A analysis in SerumDiagnostic 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.
YKL-40 analysis in SerumDiagnostic 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.
Periodontal assesmentDiagnostic test
Comprehensive periodontal assessments will be conducted, including Plaque Index (PI), Bleeding on Probing (BOP), Probing Pocket Depth (PPD), and Clinical Attachment Level (CAL).
| Study group | Role | What they receive |
|---|---|---|
| 1 group : Control (C) | 1 group : Control (C): Healthy individuals without psoriasis, gingivitis or periodontitis. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
TNF-α levels in gingival crevicular fluid (GCF)
Levels of TNF-α will be measured using ELISA in GCF samples collected at baseline.
Measured: At baseline (single visit)
TNF-α levels in serum
Levels of TNF-α will be measured using ELISA in serum samples collected at baseline.
Measured: 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.
Measured: At baseline (single visit).
IL-17A levels in serum
Levels of IL-17A will be measured using ELISA in GCF samples collected at baseline.
Measured: 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.
Measured: At baseline (single visit).
YKL-40 levels in serum
Levels of TNF-α will be measured using ELISA in serum samples collected at baseline.
Measured: At baseline (single visit).
Periodontal assesment
Probing Pocket Depth (PPD), Clinical Attachment Level (CAL), Bleeding on Probing (BOP), Plaque Index (PI) collected at baseline.
Measured: At baseline (single visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start4 Nov 2024
- Primary completion3 Mar 2025
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Psoriasis (PsO)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhala Vatankha Sain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhala Vatankha Sain, Akdeniz University
- Investigators
- Zhala Vatankha Sain, DDS, Principal investigator, Akdeniz University, Faculty of Dentistry, Department of PeriodontologyKemal Üstün, Prof., Study chair, Akdeniz University, Faculty of Dentistry, Department of PeriodontologyÖzlem Daltaban, Assoc. Prof., Study director, Akdeniz University, Faculty of Dentistry, Department of Periodontology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06897722
- Sponsor's protocol ID
- AkdenizU Organization
- Status last verified
- Nov 2024
- First submitted
- 20 Mar 2025
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The decision to share individual participant data (IPD) has not been finalized. Future data-sharing plans will depend on institutional policies, ethical considerations, and applicable regulatory requirements.
Publications
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.
PubMed 31298974Zhang 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.
PubMed 32852860Mendes 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.
PubMed 30387155Armstrong 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.
PubMed 32022825Marruganti 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.
PubMed 38699834Gorska 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.
PubMed 15002890Jimenez 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.
PubMed 33531183
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06897722
- Acronym / sponsor ID
- AkdenizU Organization
- Conditions
- Psoriasis (PsO), Periodontal Disease
- Keywords
- Psoriasis, Periodontitis, GCF, TNF-α, IL-17A, YKL-40, Serum Markers
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Zhala Vatankha SainUniversity, hospital or other
- Study start
- 4 Nov 2024 (actual)
- Primary completion
- 3 Mar 2025 (actual)
- Study completion
- Apr 2025 (estimated)
- First posted
- 27 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Psoriasis and periodontitis are chronic inflammatory diseases that share key immunopathological mechanisms. Psoriasis is primarily a dermatological condition, but it also exhibits systemic inflammatory characteristics that may contribute to comorbidities such as periodontitis. Periodontitis, a chronic immune-inflammatory condition of the supporting structures of the teeth, is similarly characterized by sustained inflammatory responses and tissue destruction.
Emerging evidence suggests that these two diseases may be biologically linked through shared inflammatory pathways. Among the common mediators, tumor necrosis factor-alpha (TNF-α), interleukin-17A (IL-17A), and YKL-40 play prominent roles in the pathogenesis of both conditions. TNF-α contributes to immune activation, tissue breakdown, and bone resorption. IL-17A, associated with Th17-mediated responses, promotes keratinocyte proliferation and inflammatory cell infiltration in psoriasis, while driving extracellular matrix degradation and osteoclastogenesis in periodontitis. YKL-40, a glycoprotein involved in tissue remodeling and inflammation, has been proposed as a potential biomarker for chronic inflammatory diseases, including psoriasis and periodontitis.
While elevated levels of these markers have been individually observed in serum or tissues of patients with either condition, limited data exist on their expression in both systemic and local environments-particularly within the gingival crevicular fluid (GCF) of psoriasis patients. This study will address this gap by assessing TNF-α, IL-17A, and YKL-40 levels in GCF and serum samples of individuals with and without psoriasis and periodontal disease.
Through a cross-sectional, case-control study design, this research aims to investigate whether systemic inflammation associated with psoriasis correlates with increased periodontal inflammation and whether common biomarkers may indicate a shared pathogenic mechanism. Understanding this potential link could lead to improved interdisciplinary management strategies and earlier identification of periodontal risk in patients with psoriasis.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 group : Control (C) | – | 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 assesment1 group : Control (C): Healthy individuals without psoriasis, gingivitis or periodontitis. |
| 2. group Gingivitis (G) | – | 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 assesmentGingivitis (G): Individuals diagnosed with gingivitis but without psoriasis. |
| 3. group Periodontitis (P) | – | 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 assesment3. group Periodontitis (P): Individuals diagnosed with periodontitis but without psoriasis. |
| 4. group Psoriasis with gingivitis (PS+G) | – | 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 assesment4. group Psoriasis with gingivitis (PS+G): Individuals diagnosed with gingivitis and psoriasis. |
| 5. group Psoriasis with Periodontitis (PS+P) | – | 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 assesment5. group Psoriasis with Periodontitis (PS+P): Individuals diagnosed with psoriasis and periodontitis. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TNF-α analysis in GCFThe 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 | 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 GCFThe 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 | 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 GCFThe 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 | 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 SerumThe 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 | 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 SerumThe 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 | 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 SerumThe 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 | 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 assesmentComprehensive periodontal assessments will be conducted, including Plaque Index (PI), Bleeding on Probing (BOP), Probing Pocket Depth (PPD), and Clinical Attachment Level (CAL). | Diagnostic test | 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) |
Primary outcome
TNF-α levels in gingival crevicular fluid (GCF)
Time frame: At baseline (single visit)
Levels of TNF-α will be measured using ELISA in GCF samples collected at baseline.
TNF-α levels in serum
Time frame: At baseline (single visit).
Levels of TNF-α will be measured using ELISA in serum samples collected at baseline.
IL-17A levels in gingival crevicular fluid (GCF)
Time frame: At baseline (single visit).
Levels of İL-17A will be measured using ELISA in serum samples collected at baseline.
IL-17A levels in serum
Time frame: At baseline (single visit).
Levels of IL-17A will be measured using ELISA in GCF samples collected at baseline.
YKL-40 levels in gingival crevicular fluid (GCF)
Time frame: At baseline (single visit).
Levels of YKL-40 will be measured using ELISA in GCF samples collected at baseline.
YKL-40 levels in serum
Time frame: At baseline (single visit).
Levels of TNF-α will be measured using ELISA in serum samples collected at baseline.
Periodontal assesment
Time frame: At baseline (single visit)
Probing Pocket Depth (PPD), Clinical Attachment Level (CAL), Bleeding on Probing (BOP), Plaque Index (PI) collected at baseline.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Results publication: PubMed 31298974Kong 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.
- Results publication: PubMed 32852860Zhang 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.
- Results publication: PubMed 30387155Mendes 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.
- Results publication: PubMed 32022825Armstrong 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.
- Results publication: PubMed 38699834Marruganti 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.
- Results publication: PubMed 15002890Gorska 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.
- Results publication: PubMed 33531183Jimenez 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.
- Individual participant dataSharing planned: Undecided. The decision to share individual participant data (IPD) has not been finalized. Future data-sharing plans will depend on institutional policies, ethical considerations, and applicable regulatory requirements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhala Vatankha Sain, DDS principal investigator
Akdeniz University, Faculty of Dentistry, Department of Periodontology
Kemal Üstün, Prof. study chair
Akdeniz University, Faculty of Dentistry, Department of Periodontology
Özlem Daltaban, Assoc. Prof. study director
Akdeniz University, Faculty of Dentistry, Department of Periodontology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis (PsO) and Periodontal Disease, run by Zhala Vatankha Sain at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TNF-α levels in gingival crevicular fluid (GCF) (time frame: At baseline (single visit)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06897722, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.