An observational study in Periodontal Health, Gingivitis and Periodontitis, sponsored by Yuzuncu Yil University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Yuzuncu Yil University · Observational
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.
609 studies on the registry are indexed under Gingivitis; 107 are open to participants now.
This study's planned enrollment of 60 is below the median of 90 across 107 observational studies indexed under Gingivitis.
Browse Gingivitis studies →Yuzuncu Yil University is the lead sponsor of 75 studies on the registry; 19 are open to participants now.
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Participants will be recruited from patients attending the Department of Periodontology, Faculty of Dentistry, Van Yuzuncu Yil University. Sixty systemically healthy adults aged 18-65 years will be enrolled and classified into three groups according to the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions: periodontal health (n=20), gingivitis (n=20), and periodontitis (n=20).
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General (for all participants):
Group-specific criteria:
Periodontal Health Group:
Gingivitis Group:
Periodontitis Group:
Systemically healthy individuals diagnosed with Stage III-IV periodontitis according to the 2017 World Workshop classification, confirmed by clinical and radiographic examination. Stage III: interdental CAL ≥5 mm, radiographic bone loss extending to the middle third of the root or beyond, tooth loss due to periodontitis ≤4 teeth, and at least one of the following: PD ≥6 mm, vertical bone loss ≥3 mm, Class II/III furcation involvement, or moderate ridge defect. Stage IV: the criteria for Stage III plus tooth loss due to periodontitis ≥5 teeth and at least one of the following: masticatory dysfunction, secondary occlusal trauma, severe ridge defect, bite collapse, or fewer than 20 remaining teeth. Two GCF samples will be collected from each participant: one from the deepest periodontal pocket and one from a clinically healthy site in the same individual.
Exclusion Criteria:
Systemic conditions:
Tobacco and nicotine use:
- Active use of cigarettes, hookah, electronic cigarettes, or any nicotine product
Medications and treatment history:
Systemically healthy individuals with bleeding on probing (BOP) \<10%, probing depth (PD) ≤3 mm, and no interdental clinical attachment loss (CAL).
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.
Diagnostic Test: Clinical periodontal examination · Diagnostic Test: ELISA-based biomarker analysis
Systemically healthy individuals diagnosed with Stage III-IV periodontitis according to the 2017 World Workshop classification, confirmed by clinical and radiographic examination. Stage III: interdental CAL ≥5 mm, radiographic bone loss extending to the middle third of the root or beyond, tooth loss due to periodontitis ≤4 teeth, and at least one of the following: PD ≥6 mm, vertical bone loss ≥3 mm, Class II/III furcation involvement, or moderate ridge defect. Stage IV: the criteria for Stage III plus tooth loss due to periodontitis ≥5 teeth and at least one of the following: masticatory dysfunction, secondary occlusal trauma, severe ridge defect, bite collapse, or fewer than 20 remaining teeth. Two GCF samples will be collected from each participant: one from the deepest periodontal pocket and one from a clinically healthy site in the same individual.
Diagnostic Test: Clinical periodontal examination · Diagnostic Test: ELISA-based biomarker analysis
Full-mouth periodontal examination including PD, CAL, BOP, plaque index, and gingival index, performed by a single calibrated examiner.
Irisin, IL-6, IL-10, and TNF-α levels measured by human-specific ELISA kits in unstimulated whole saliva and GCF samples collected.
Irisin levels in saliva and GCF
Salivary and GCF irisin levels measured by human-specific ELISA kit, compared across periodontal health, gingivitis, and periodontitis groups
Time frame: Single time point at baseline (day of sample collection)
IL-6 levels in saliva and GCF
Salivary and GCF IL-6 levels measured by human-specific ELISA kit, compared across periodontal health, gingivitis, and periodontitis groups
Time frame: Single time point at baseline (day of sample collection)
TNF-α levels in saliva and GCF
Salivary and GCF TNF-α levels measured by human-specific ELISA kit, compared across periodontal health, gingivitis, and periodontitis groups
Time frame: Single time point at baseline (day of sample collection)
IL-10 levels in saliva and GCF
Salivary and GCF IL-10 levels measured by human-specific ELISA kit, compared across periodontal health, gingivitis, and periodontitis groups
Time frame: Single time point at baseline (day of sample collection)
Correlation between biomarker levels and clinical periodontal parameters
Association between salivary and GCF biomarker levels (irisin, IL-6, TNF-α, IL-10) and clinical parameters including PD, BOP, and CAL.
Time frame: Single time point at baseline (day of sample collection)
Plan to share: No — Individual participant data will not be shared due to institutional privacy regulations and the absence of a data sharing infrastructure. Aggregate study results will be reported in peer-reviewed publications.
Start is estimated for Oct 2026; primary completion for Apr 2027, 6 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Yuzuncu Yil University