Evaluation of Salivary and Serum Levels of TNF-α, IL-17A, and YKL-40 in Individuals With Psoriasis

NCT06984237 | Active Not Recruiting

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

Brief Summary

Background: Periodontitis is a chronic inflammatory disease triggered by microbial infections that lead to the destruction of tissues supporting the teeth. Psoriasis is a chronic skin condition characterized by excessive proliferation and abnormal differentiation of keratinocytes. Due to the presence of similar inflammatory mechanisms, an immunological relationship between psoriasis and periodontal disease has been hypothesized. To explore this relationship, the levels of TNF-α, IL-17A, and YKL-40 in saliva and serum will be examined in both systemically healthy individuals and individuals with psoriasis. Methods: The study will include five distinct groups based on systemic and periodontal conditions:

1. 1.systemically and periodontally healthy individuals (H),
2. 2.systemically healthy individuals with gingivitis (Control Gingivitis, CG),
3. 3.systemically healthy individuals with periodontitis (Control Periodontitis, CP),
4. 4.individuals with psoriasis and gingivitis (Psoriasis Gingivitis, PG), and
5. 5.individuals with psoriasis and periodontitis (Psoriasis Periodontitis, PP). Levels of TNF-α, IL-17A, and YKL-40 will be measured in both saliva and serum samples. Additionally, correlations among these cytokines and between cytokine levels and clinical periodontal parameters-including Plaque Index (PI), Bleeding on Probing (BOP), Probing Pocket Depth (PPD), and Clinical Attachment Level (CAL)-will be analyzed.

Conditions

Periodontitis; Psoriasis

Keywords

TNF-α; IL-17A; YKL-40; salivary; serum

Outcome Measures

Primary Outcomes (6)

• TNF-α levels in saliva

  The level of tumor necrosis factor-alpha (TNF-α) in saliva, measured in picograms per milliliter (pg/mL), will be recorded at the initial visit.

  at baseline (single visit)

• TNF-α levels in serum

  The level of tumor necrosis factor-alpha (TNF-α) in serum, measured in picograms per milliliter (pg/mL), will be recorded at the initial visit.

  at baseline (single visit)

• IL-17A levels in saliva

  The level of interleukin-17A (IL-17A) in saliva, measured in picograms per milliliter (pg/mL), will be recorded at the initial visit.

  at baseline (single visit)

• IL-17A levels in serum

  The level of interleukin-17A (IL-17A) in serum, measured in picograms per milliliter (pg/mL), will be recorded at the initial visit

  at baseline (single visit)

• YKL-40 levels in saliva

  The level of YKL-40 in saliva, measured in picograms per milliliter (pg/mL), will be recorded at the initial visit.

  at baseline (single visit)

• YKL-40 levels in serum

  The level of YKL-40 in serum, measured in nanograms per milliliter (ng/mL), will be recorded at the initial visit.

  at baseline (single visit)

Secondary Outcomes (4)

• periodontal assesment

  at baseline (single visit)

• Periodontal Assesment

  Baseline (at single visit)

• Periodontal Assesment

  Baseline (at single visit)

• Periodontal Assessment

  Baseline (at single visit)

Study Arms (5)

1. Group: Healthy (H)

1\. Group: Healthy (H):Systemically and periodontally healthy individuals (H)

Diagnostic Test: TNF-α Analysis in saliva; Diagnostic Test: IL-17A analysis in saliva; Diagnostic Test: YKL-40 Analysis in saliva; Diagnostic Test: TNF-α analysis in serum; Diagnostic Test: IL-17A analysis in serum; Diagnostic Test: YKL-40 analysis in serum; Diagnostic Test: Clinical periodontal evaluation

2. Group: Control Gingivitis(CG)

2\. Group: Control Gingivitis(CG): Systemically healthy individuals with gingivitis

Diagnostic Test: TNF-α Analysis in saliva; Diagnostic Test: IL-17A analysis in saliva; Diagnostic Test: YKL-40 Analysis in saliva; Diagnostic Test: TNF-α analysis in serum; Diagnostic Test: IL-17A analysis in serum; Diagnostic Test: YKL-40 analysis in serum; Diagnostic Test: Clinical periodontal evaluation

3. Group: Control Periodontitis(CP)

3\. Group: Control Periodontitis(CP): Systemically healthy individuals with periodontitis

Diagnostic Test: TNF-α Analysis in saliva; Diagnostic Test: IL-17A analysis in saliva; Diagnostic Test: YKL-40 Analysis in saliva; Diagnostic Test: TNF-α analysis in serum; Diagnostic Test: IL-17A analysis in serum; Diagnostic Test: YKL-40 analysis in serum; Diagnostic Test: Clinical periodontal evaluation

4. Group: Psoriasis Gingivitis(PG)

4\. Group: Psoriasis Gingivitis(PG): Individuals with psoriasis and gingivitis

Diagnostic Test: TNF-α Analysis in saliva; Diagnostic Test: IL-17A analysis in saliva; Diagnostic Test: YKL-40 Analysis in saliva; Diagnostic Test: TNF-α analysis in serum; Diagnostic Test: IL-17A analysis in serum; Diagnostic Test: YKL-40 analysis in serum; Diagnostic Test: Clinical periodontal evaluation

5. Group: Psoriasis Periodontitis (PP)

5\. Group: Psoriasis Periodontitis (PP): Individuals with psoriasis and periodontitis

Diagnostic Test: TNF-α Analysis in saliva; Diagnostic Test: IL-17A analysis in saliva; Diagnostic Test: YKL-40 Analysis in saliva; Diagnostic Test: TNF-α analysis in serum; Diagnostic Test: IL-17A analysis in serum; Diagnostic Test: YKL-40 analysis in serum; Diagnostic Test: Clinical periodontal evaluation

Interventions

TNF-α Analysis in saliva DIAGNOSTIC_TEST

Unstimulated whole saliva samples will be collected in the morning, at least one day after periodontal examination. Participants will be instructed to refrain from eating, drinking, brushing, or chewing gum for at least one hour before collection. The samples will be centrifuged at 1500 rpm for 10 minutes, and the supernatants will be stored at -80°C until analysis. TNF-α levels will be measured using ELISA.

1. Group: Healthy (H); 2. Group: Control Gingivitis(CG); 3. Group: Control Periodontitis(CP); 4. Group: Psoriasis Gingivitis(PG); 5. Group: Psoriasis Periodontitis (PP)

IL-17A analysis in saliva DIAGNOSTIC_TEST

Unstimulated whole saliva samples will be collected in the morning, at least one day after periodontal examination. Participants will be asked to avoid eating, drinking, brushing their teeth, or chewing gum for at least one hour prior to sampling. The samples will be centrifuged at 1500 rpm for 10 minutes, and the supernatants will be stored at -80°C until analysis. IL-17A levels will be determined using ELISA.

1. Group: Healthy (H); 2. Group: Control Gingivitis(CG); 3. Group: Control Periodontitis(CP); 4. Group: Psoriasis Gingivitis(PG); 5. Group: Psoriasis Periodontitis (PP)

YKL-40 Analysis in saliva DIAGNOSTIC_TEST

Unstimulated whole saliva samples will be obtained from participants in the morning, at least one day after the periodontal clinical assessment. They will be instructed not to eat, drink, chew gum, or brush their teeth for at least one hour before collection. Samples will be centrifuged at 1500 rpm for 10 minutes, and the clear supernatants will be stored at -80°C until the time of analysis. YKL-40 levels will be measured using ELISA.

1. Group: Healthy (H); 2. Group: Control Gingivitis(CG); 3. Group: Control Periodontitis(CP); 4. Group: Psoriasis Gingivitis(PG); 5. Group: Psoriasis Periodontitis (PP)

TNF-α analysis in serum DIAGNOSTIC_TEST

A total of 8 mL of venous blood will be collected from the antecubital fossa of seated participants. Samples will be transferred into BD Vacutainer® SST™ II Advance serum separator tubes containing acrylic gel and will be allowed to clot for 30 minutes at room temperature. The samples will then be centrifuged at 1500 rpm for 10 minutes at 18-25°C. The resulting serum will be transferred into Eppendorf tubes using a Pasteur pipette and will be stored at -80°C until analysis. TNF-α levels will be measured using ELISA.

1. Group: Healthy (H); 2. Group: Control Gingivitis(CG); 3. Group: Control Periodontitis(CP); 4. Group: Psoriasis Gingivitis(PG); 5. Group: Psoriasis Periodontitis (PP)

IL-17A analysis in serum DIAGNOSTIC_TEST

A total of 8 mL of venous blood will be obtained from the antecubital fossa of participants in a seated position. After collection, the blood will be placed into BD Vacutainer® SST™ II Advance tubes with acrylic gel and will rest for 30 minutes to allow clotting. The samples will be centrifuged at 1500 rpm for 10 minutes at 18-25°C. The serum will be extracted using a Pasteur pipette and stored in Eppendorf tubes at -80°C until analysis. IL-17A levels will be analyzed using ELISA.

1. Group: Healthy (H); 2. Group: Control Gingivitis(CG); 3. Group: Control Periodontitis(CP); 4. Group: Psoriasis Gingivitis(PG); 5. Group: Psoriasis Periodontitis (PP)

YKL-40 analysis in serum DIAGNOSTIC_TEST

Venous blood (8 mL) will be drawn from the antecubital fossa of seated participants. The samples will be placed in BD Vacutainer® SST™ II Advance tubes containing acrylic gel and will be left to clot for 30 minutes at room temperature. Following this, the samples will be centrifuged at 1500 rpm for 10 minutes at 18-25°C. The supernatant serum will be separated with a Pasteur pipette and transferred into Eppendorf tubes. All samples will be stored at -80°C until analysis. YKL-40 levels will be measured using ELISA.

1. Group: Healthy (H); 2. Group: Control Gingivitis(CG); 3. Group: Control Periodontitis(CP); 4. Group: Psoriasis Gingivitis(PG); 5. Group: Psoriasis Periodontitis (PP)

Clinical periodontal evaluation DIAGNOSTIC_TEST

Clinical periodontal parameters will be recorded from participants who meet the inclusion criteria. The following indices will be measured from all teeth present in the oral cavity: Plaque Index (PI; Silness \& Löe, 1964), Probing Pocket Depth (PPD), Clinical Attachment Level (CAL), and Bleeding on Probing (BOP). Radiographic evaluations will also be performed. All measurements will be conducted by the same calibrated clinician (HD) using a Williams periodontal probe (Hu-Friedy, Chicago, IL, USA).

1. Group: Healthy (H); 2. Group: Control Gingivitis(CG); 3. Group: Control Periodontitis(CP); 4. Group: Psoriasis Gingivitis(PG); 5. Group: Psoriasis Periodontitis (PP)

Eligibility Criteria

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

Study Population

A total of 100 participants are included after providing informed consent and meeting inclusion criteria. Participants are divided into five equal groups (n=20 per group): 1. Systemically and periodontally healthy individuals (H), 2. Systemically healthy individuals with gingivitis (Control Gingivitis, CG), 3. Systemically healthy individuals with periodontitis (Control Periodontitis, CP), 4. Individuals with psoriasis and gingivitis (Psoriasis Gingivitis, PG), and 5. Individuals with psoriasis and periodontitis (Psoriasis Periodontitis, PP). Periodontal diagnoses are made based on the 2017 classification system of the American Academy of Periodontology (AAP) and the European Federation of Periodontology (EFP).

You may qualify if:

• Voluntary participation
• No use of antibiotics within the past 6 months
• No periodontal treatment within the past 6 months
• Absence of systemic diseases known to affect periodontal health (e.g., diabetes, cardiovascular diseases)
• No infectious diseases such as tuberculosis, hepatitis, or AIDS
• Age 18 years or older
• Not pregnant (for female participants)

You may not qualify if:

• Pregnancy or ongoing lactation
• History of gingival treatment within the past 6 months
• History of any disease involving the oral mucosa (e.g., lichen planus, pemphigus vulgaris, chronic ulcerative stomatitis)
• Current use of systemic corticosteroids, immunosuppressive agents, or biological drugs
• History of systemic inflammatory diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, irritable bowel syndrome, diabetes mellitus)
• Fewer than 20 natural teeth (excluding third molars)
• Current smokers
• Age younger than 18 or older than 65 years

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Akdeniz University, Fculty of Dentistry, Akdeniz University Hospital

Antalya, 07070, Turkey (Türkiye)

Location

Related Publications (5)

• 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

• Martinez-Garcia M, Hernandez-Lemus E. Periodontal Inflammation and Systemic Diseases: An Overview. Front Physiol. 2021 Oct 27;12:709438. doi: 10.3389/fphys.2021.709438. eCollection 2021.

  PMID: 34776994 BACKGROUND

• de Oliveira PS, Cardoso PR, Lima EV, Pereira MC, Duarte AL, Pitta Ida R, Rego MJ, Pitta MG. IL-17A, IL-22, IL-6, and IL-21 Serum Levels in Plaque-Type Psoriasis in Brazilian Patients. Mediators Inflamm. 2015;2015:819149. doi: 10.1155/2015/819149. Epub 2015 Aug 13.

  PMID: 26351408 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

• 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

MeSH Terms

Conditions

Periodontitis; Psoriasis

Condition Hierarchy (Ancestors)

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

Study Officials

• Hazal DURMUS, DDS

  Akdeniz Universty, Faculty Of Dentistry, Department Of Periodontology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS

Study Record Dates

• First Submitted: May 8, 2025
• First Posted: May 22, 2025
• Study Start: December 2, 2024
• Primary Completion: April 18, 2025
• Study Completion: May 1, 2025
• Last Updated: May 22, 2025

Record last verified: 2025-05

Locations

TU (1)