PeriodontitisNCT06984237
Evaluation of Salivary and Serum Levels of TNF-α, IL-17A, and YKL-40 in Individuals With Psoriasis
An observational study of Periodontitis and Psoriasis, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Psoriasis
- What is being tested?
- TNF-α Analysis in saliva, IL-17A analysis in saliva and YKL-40 Analysis in saliva
- Type of treatment
- Pill or oral medicine
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Dec 2024to May 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Akdeniz University, Fculty of Dentistry, Akdeniz University Hospital
Antalya, 07070
About this study
Official title: Psoriasis and Periodontitis Are Chronic Inflammatory Diseases That May Share Common Immunopathogenic Pathways. TNF-α, IL-17A, and YKL-40 Are Inflammatory Biomarkers Associated With Both Conditions. This Study Aims to Evaluate the Levels of These Markers in Saliva and Serum of Individuals With Psoriasis, Considering Their Periodontal Status, to Investigate a Potential Link Between the Two Diseases
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:
Read more
- systemically and periodontally healthy individuals (H),
- systemically healthy individuals with gingivitis (Control Gingivitis, CG),
- systemically healthy individuals with periodontitis (Control Periodontitis, CP),
- individuals with psoriasis and gingivitis (Psoriasis Gingivitis, PG), and
- 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.
Conclusion: The study is expected to provide insight into the immunological link between psoriasis and periodontal disease by evaluating TNF-α, IL-17A, and YKL-40 levels at both local (saliva) and systemic (serum) levels.
Read the detailed description
Periodontitis is a chronic inflammatory disease affecting the supporting structures of the teeth, characterized by gingival inflammation, destruction of periodontal tissues, and alveolar bone loss. The disease primarily develops due to bacterial colonization at the tooth-gingival interface. Inflammatory mediators released in response to the interaction between a dysbiotic microbial biofilm and the host immune system play a critical role in tissue destruction and disease progression. Systemic conditions that affect the host immune system may exacerbate periodontal destruction in this multifactorial disease.
Psoriasis is a chronic inflammatory skin condition characterized by erythematous plaques or papules covered with silvery-white scales. The prevalence ranges between 1% and 3%, depending on the ethnic population, and it affects both genders equally. Although the exact etiopathogenesis of psoriasis remains unclear, several environmental and systemic factors-such as trauma, ultraviolet radiation, infections, medications, endocrine influences, psychological stress, alcohol consumption, and smoking-have been identified as potential triggers.
A possible association between psoriasis and periodontitis has been reported in multiple clinical studies and meta-analyses. Interleukin-17 (IL-17) is a pro-inflammatory cytokine that induces the expression of various inflammation-related mediators. It plays a central role in immune regulation and is implicated in inflammatory diseases, autoimmune disorders, and cancer. Elevated IL-17A levels have been detected in both psoriatic skin and serum samples of individuals with psoriasis when compared to healthy controls.
Tumor necrosis factor-alpha (TNF-α) is a polypeptide cytokine produced primarily by macrophages and monocytes. It functions as a multipotent regulator in immune responses by stimulating fibroblasts to release collagenase, increasing vascular permeability, promoting the release of other cytokines (such as IL-1α, IL-1β, IL-6, and IL-8), and enhancing the production of matrix metalloproteinases and adhesion molecules. TNF-α also synergizes with IL-1 to promote bone resorption. Elevated TNF-α levels in both serum and psoriatic lesions have been shown to decrease following effective treatment.
YKL-40 is a 40-kDa glycoprotein composed of tyrosine (Y), lysine (K), and leucine (L) at its N-terminal. It is secreted by neutrophils, macrophages, chondrocytes, synovial cells, osteoblasts, endothelial cells, and cancer cells. YKL-40 is associated with immune responses involving inflammation, tissue remodeling, and angiogenesis, and is considered an acute-phase protein.
A limited number of studies addressing the pathogenesis-related association between psoriasis and periodontal status have been identified in the literature, indicating a need for further investigation. To address this gap, a study is planned in which biomarkers associated with both periodontitis and psoriasis will be evaluated at both local and systemic levels.
The primary objective will be to comparatively assess TNF-α, IL-17A, and YKL-40 levels in saliva and serum samples of individuals with psoriasis, along with relevant clinical periodontal parameters.
- Conditions
- Periodontitis, Psoriasis
- Being tested
- TNF-α Analysis in saliva, IL-17A analysis in saliva, YKL-40 Analysis in saliva, TNF-α analysis in serum, IL-17A analysis in serum
- Keywords
- TNF-α, IL-17A, YKL-40, salivary, serum
- Medical subject headings
- Periodontitis, Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TNF-α Analysis in salivaDiagnostic 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.
IL-17A analysis in salivaDiagnostic 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.
YKL-40 Analysis in salivaDiagnostic 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.
TNF-α analysis in serumDiagnostic 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.
IL-17A analysis in serumDiagnostic 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.
YKL-40 analysis in serumDiagnostic 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.
Clinical periodontal evaluationDiagnostic 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).
| Study group | Role | What they receive |
|---|---|---|
| 1. Group: Healthy (H) | 1. Group: Healthy (H):Systemically and periodontally healthy individuals (H) Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: at baseline (single visit)
Secondary outcomes (4)
periodontal assesment
probing pocket depth(PPD): Average probing pocket depth measured in millimeters at the initial visit.
Measured: at baseline (single visit)
Periodontal Assesment
Bleeding on Probing (BOP): Percentage of sites with bleeding on probing measured at the initial visit
Measured: Baseline (at single visit)
Periodontal Assesment
Plaque Index (PI): Plaque Index score measured at the initial visit
Measured: Baseline (at single visit)
Periodontal Assessment
Clinical Attachment Level (CAL): Clinical Attachment Level measured in millimeters at the initial visit
Measured: Baseline (at single visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start2 Dec 2024
- Primary completion18 Apr 2025
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- 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
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hazal Durmus, Akdeniz University
- Investigators
- Hazal DURMUS, DDS, Principal investigator, Akdeniz Universty, Faculty Of Dentistry, Department Of Periodontology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06984237
- Sponsor's protocol ID
- AkdenizU Psoriasis
- Status last verified
- May 2025
- First submitted
- 8 May 2025
- Last updated
- 22 May 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 31298974Martinez-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.
PubMed 34776994de 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.
PubMed 26351408Jimenez 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 33531183Marruganti 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 38699834
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psoriasis and Periodontitis Are Chronic Inflammatory Diseases That May Share Common Immunopathogenic Pathways. TNF-α, IL-17A, and YKL-40 Are Inflammatory Biomarkers Associated With Both Conditions. This Study Aims to Evaluate the Levels of These Markers in Saliva and Serum of Individuals With Psoriasis, Considering Their Periodontal Status, to Investigate a Potential Link Between the Two Diseases
- ClinicalTrials.gov ID
- NCT06984237
- Acronym / sponsor ID
- AkdenizU Psoriasis
- Conditions
- Periodontitis, Psoriasis
- Keywords
- TNF-α, IL-17A, YKL-40, salivary, serum
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 2 Dec 2024 (actual)
- Primary completion
- 18 Apr 2025 (actual)
- Study completion
- May 2025 (estimated)
- First posted
- 22 May 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: 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:
- systemically and periodontally healthy individuals (H),
- systemically healthy individuals with gingivitis (Control Gingivitis, CG),
- systemically healthy individuals with periodontitis (Control Periodontitis, CP),
- individuals with psoriasis and gingivitis (Psoriasis Gingivitis, PG), and
- 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.
Conclusion: The study is expected to provide insight into the immunological link between psoriasis and periodontal disease by evaluating TNF-α, IL-17A, and YKL-40 levels at both local (saliva) and systemic (serum) levels.
Detailed description
Periodontitis is a chronic inflammatory disease affecting the supporting structures of the teeth, characterized by gingival inflammation, destruction of periodontal tissues, and alveolar bone loss. The disease primarily develops due to bacterial colonization at the tooth-gingival interface. Inflammatory mediators released in response to the interaction between a dysbiotic microbial biofilm and the host immune system play a critical role in tissue destruction and disease progression. Systemic conditions that affect the host immune system may exacerbate periodontal destruction in this multifactorial disease.
Psoriasis is a chronic inflammatory skin condition characterized by erythematous plaques or papules covered with silvery-white scales. The prevalence ranges between 1% and 3%, depending on the ethnic population, and it affects both genders equally. Although the exact etiopathogenesis of psoriasis remains unclear, several environmental and systemic factors-such as trauma, ultraviolet radiation, infections, medications, endocrine influences, psychological stress, alcohol consumption, and smoking-have been identified as potential triggers.
A possible association between psoriasis and periodontitis has been reported in multiple clinical studies and meta-analyses. Interleukin-17 (IL-17) is a pro-inflammatory cytokine that induces the expression of various inflammation-related mediators. It plays a central role in immune regulation and is implicated in inflammatory diseases, autoimmune disorders, and cancer. Elevated IL-17A levels have been detected in both psoriatic skin and serum samples of individuals with psoriasis when compared to healthy controls.
Tumor necrosis factor-alpha (TNF-α) is a polypeptide cytokine produced primarily by macrophages and monocytes. It functions as a multipotent regulator in immune responses by stimulating fibroblasts to release collagenase, increasing vascular permeability, promoting the release of other cytokines (such as IL-1α, IL-1β, IL-6, and IL-8), and enhancing the production of matrix metalloproteinases and adhesion molecules. TNF-α also synergizes with IL-1 to promote bone resorption. Elevated TNF-α levels in both serum and psoriatic lesions have been shown to decrease following effective treatment.
YKL-40 is a 40-kDa glycoprotein composed of tyrosine (Y), lysine (K), and leucine (L) at its N-terminal. It is secreted by neutrophils, macrophages, chondrocytes, synovial cells, osteoblasts, endothelial cells, and cancer cells. YKL-40 is associated with immune responses involving inflammation, tissue remodeling, and angiogenesis, and is considered an acute-phase protein.
A limited number of studies addressing the pathogenesis-related association between psoriasis and periodontal status have been identified in the literature, indicating a need for further investigation. To address this gap, a study is planned in which biomarkers associated with both periodontitis and psoriasis will be evaluated at both local and systemic levels.
The primary objective will be to comparatively assess TNF-α, IL-17A, and YKL-40 levels in saliva and serum samples of individuals with psoriasis, along with relevant clinical periodontal parameters.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1. Group: Healthy (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 evaluation1. Group: Healthy (H):Systemically and periodontally healthy individuals (H) |
| 2. Group: Control Gingivitis(CG) | – | 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 evaluation2. Group: Control Gingivitis(CG): Systemically healthy individuals with gingivitis |
| 3. Group: Control Periodontitis(CP) | – | 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 evaluation3. Group: Control Periodontitis(CP): Systemically healthy individuals with periodontitis |
| 4. Group: Psoriasis Gingivitis(PG) | – | 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 evaluation4. Group: Psoriasis Gingivitis(PG): Individuals with psoriasis and gingivitis |
| 5. Group: Psoriasis Periodontitis (PP) | – | 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 evaluation5. Group: Psoriasis Periodontitis (PP): Individuals with psoriasis and periodontitis |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
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 salivaUnstimulated 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. | Diagnostic test | 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 salivaUnstimulated 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. | Diagnostic test | 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 salivaUnstimulated 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. | Diagnostic test | 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 serumA 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. | Diagnostic test | 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 serumA 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. | Diagnostic test | 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 serumVenous 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. | Diagnostic test | 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 evaluationClinical 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). | Diagnostic test | 1. Group: Healthy (H), 2. Group: Control Gingivitis(CG), 3. Group: Control Periodontitis(CP), 4. Group: Psoriasis Gingivitis(PG), 5. Group: Psoriasis Periodontitis (PP) |
Primary outcome
TNF-α levels in saliva
Time frame: at baseline (single visit)
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.
TNF-α levels in serum
Time frame: at baseline (single visit)
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.
IL-17A levels in saliva
Time frame: at baseline (single visit)
The level of interleukin-17A (IL-17A) in saliva, measured in picograms per milliliter (pg/mL), will be recorded at the initial visit.
IL-17A levels in serum
Time frame: at baseline (single visit)
The level of interleukin-17A (IL-17A) in serum, measured in picograms per milliliter (pg/mL), will be recorded at the initial visit
YKL-40 levels in saliva
Time frame: at baseline (single visit)
The level of YKL-40 in saliva, measured in picograms per milliliter (pg/mL), will be recorded at the initial visit.
YKL-40 levels in serum
Time frame: at baseline (single visit)
The level of YKL-40 in serum, measured in nanograms per milliliter (ng/mL), will be recorded at the initial visit.
4 secondary outcomes
periodontal assesment
Time frame: at baseline (single visit)
Periodontal Assesment
Time frame: Baseline (at single visit)
Periodontal Assesment
Time frame: Baseline (at single visit)
Periodontal Assessment
Time frame: Baseline (at single visit)
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 22 May 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 34776994Martinez-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.
- Results publication: PubMed 26351408de 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.
- 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.
- 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.
- 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.
Hazal DURMUS, DDS principal investigator
Akdeniz Universty, 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 Periodontitis and Psoriasis, run by Akdeniz University 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 7 inclusion and 8 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 22 May 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 saliva (time frame: at baseline (single visit)). The study lists 6 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 NCT06984237, which also lists 5 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 22 May 2025.