Comparison of Irisin, IL-6, IL-10, and TNF-α Levels in Saliva and Gingival Crevicular Fluid in Periodontal Health, Gingivitis and Periodontitis
| Registry | NCT07881406 |
|---|---|
| Status | Not yet recruiting |
| Study type | Observational |
| Enrollment | 60 (Estimated) |
| Sponsor | Yuzuncu Yil University (Other) |
| Conditions | Periodontal Health, Gingivitis, Periodontitis |
| Interventions | Clinical periodontal examination, ELISA-based biomarker analysis (Diagnostic test) |
| Dates | start 2026-10-15 (estimated), primary completion 2027-04-01 (estimated), completion 2027-07-01 (estimated), first posted 2026-10-19, last updated 2026-10-19 |
| Locations | 1 site in Turkey (Türkiye) |
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All trials for Periodontal Health All trials for Gingivitis All trials of Clinical periodontal examination All trials of ELISA-based biomarker analysis
This observational cross-sectional study aims to compare the levels of irisin, interleukin-6 (IL-6), interleukin-10 (IL-10), and tumor necrosis factor-alpha (TNF-α) in saliva and gingival crevicular fluid (GCF) among individuals with periodontal health, gingivitis, and periodontitis. Biomarker concentrations will be measured using human-specific ELISA kits. The study seeks to evaluate the diagnostic potential of these markers and to contribute to a better understanding of the inflammatory-metabolic axis in periodontal disease.
Periodontitis is a chronic multifactorial inflammatory disease associated with dysbiosis of the subgingival microbiome and destruction of periodontal supporting tissues. Irisin, a myokine/adipokine cleaved from fibronectin type III domain-containing protein 5 (FNDC5), has recently attracted attention for its potential roles in bone metabolism and oral health. This study will enroll 60 participants classified into three groups according to the 2017 World Workshop criteria: periodontal health (n=20), gingivitis (n=20), and periodontitis (n=20). Unstimulated whole saliva and GCF samples will be collected on the same day following standardized protocols. In the periodontitis group, two GCF samples will be collected per participant: one from the deepest periodontal pocket and one from a clinically healthy site of the same individual, serving as an intra-individual control. All biomarkers will be quantified in duplicate using commercial human-specific ELISA kits.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Periodontal Health | Diagnostic Test: Clinical periodontal examination; Diagnostic Test: ELISA-based biomarker analysis | Systemically healthy individuals with bleeding on probing (BOP) <10%, probing depth (PD) ≤3 mm, and no interdental clinical attachment loss (CAL). | |
| Gingivitis | Diagnostic Test: Clinical periodontal examination; Diagnostic Test: ELISA-based biomarker analysis | Systemically healthy individuals with BOP ≥10%, PD ≤3 mm, and no interdental CAL, not meeting criteria for periodontitis. | |
| Periodontitis | Diagnostic Test: Clinical periodontal examination; Diagnostic Test: ELISA-based biomarker analysis | Systemically healthy individuals diagnosed with periodontitis (Stage III-IV) according to the 2017 World Workshop classification criteria, confirmed by clinical and radiographic examination. Stage III periodontitis is diagnosed with interdental CAL is ≥ 5 mm, radiographic bone loss (BL) extends to mid-third of the root and beyond, tooth loss may become evident ≤4 teeth. Either PD ≥ 6 mm or vertical BL ≥ 3 mm, or Class II/III furcation involvement, or moderate ridge defect. Stage IV periodontitis is diagnosed with interdental CAL is ≥ 5 mm at the site of greatest loss, radiographic BL extending to mid-third of the root and beyond. ≥5 tooth loss due to periodontitis is evident. In addition to Stage III, either masticatory dysfunctio two separate GCF samples will be collected from each participant in the periodontitis group: one from the deepest periodontal pocket in the mouth and one from a clinically healthy site in the same individual. |
Sex: All, ages: 18 Years to 65 Years, accepts healthy volunteers
Inclusion Criteria: General (for all participants): * Age between 18 and 65 years * Individuals capable of providing written informed consent * Systemically healthy * Individuals able to adhere to the instructions for the study day (pre-sampling protocol) * No heavy exercise on the day of sampling Group-specific criteria: Periodontal Health Group: * BOP <10% * PD ≤3 mm * No interdental CAL * No clinical or radiographic signs of periodontitis Gingivitis Group: * BOP ≥10% * PD ≤3 mm * No interdental CAL * Not meeting criteria for periodontitis Periodontitis Group: Systemically healthy individuals diagnosed with periodontitis (Stage III-IV) according to the 2017 World Workshop classification criteria, confirmed by clinical and radiographic examination. Stage III periodontitis is diagnosed with interdental CAL is ≥ 5 mm, radiographic bone loss (BL) extends to mid-third of the root and beyond, tooth loss may become evident ≤4 teeth. Either PD ≥ 6 mm or vertical BL ≥ 3 mm, or Class II/III furcation involvement, or moderate ridge defect. Stage IV periodontitis is diagnosed with interdental CAL is ≥ 5 mm at the site of greatest loss, radiographic BL extending to mid-third of the root and beyond. ≥5 tooth loss due to periodontitis is evident. In addition to Stage III, either masticatory dysfunctio two separate GCF samples will be collected from each participant in the periodontitis group: one from the deepest periodontal pocket in the mouth and one from a clinically healthy site in the same individual. Exclusion Criteria: Systemic conditions: * Diabetes mellitus (diagnosed or HbA1c elevation or under treatment) * Autoimmune or systemic inflammatory diseases * Chronic renal or hepatic failure * Malignancy * Uncontrolled endocrine disorders (thyroid disease, Cushing syndrome, etc.) * Pregnancy or breastfeeding Tobacco and nicotine use: \- Active use of cigarettes, hookah, electronic cigarettes, or any nicotine product Medications and treatment history: * Antibiotic use within the past 3 months * Regular systemic NSAID or corticosteroid use within the past 1 month * Immunosuppressive therapy * Medications affecting bone metabolism (bisphosphonates, denosumab, etc.) * Periodontal treatment (scaling and root planing or surgery) within the past 6 months * Professional dental prophylaxis within the past 3 months * Body mass index (BMI) ≥30 (obesity) or BMI <18.5 (underweight)
| Facility | City | Country | Status |
|---|---|---|---|
| Van Yuzuncu Yıl University | Van, Van | Turkey (Türkiye) |