Comparison of Irisin, IL-6, IL-10, and TNF-α Levels in Saliva and Gingival Crevicular Fluid in Periodontal Health, Gingivitis and Periodontitis
Sponsor study identifier
Secondary identifiers
OTHER · Van Yuzuncu Yil University Scientific Research Projects Department
observational
60
1 country
1
Study Start
October 15, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
April 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 12, 2026
Actual (reported)October 15, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 19, 2026
Actual (reported)April 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
July 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
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
Single time point at baseline (day of sample collection)
TNF-α levels in saliva and GCF
Single time point at baseline (day of sample collection)
Systemically healthy individuals with bleeding on probing (BOP) \<10%, probing depth (PD) ≤3 mm, and no interdental clinical attachment loss (CAL).
Systemically healthy individuals with BOP ≥10%, PD ≤3 mm, and no interdental CAL, not meeting criteria for periodontitis.
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.
Full-mouth periodontal examination including PD, CAL, BOP, plaque index, and gingival index, performed by a single calibrated examiner.
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).
Van Yuzuncu Yil University, Faculty of Dentistry
Van, Van, 65040, Turkey (Türkiye)
de Lima Oliveira AP, de Faveri M, Gursky LC, Mestnik MJ, Feres M, Haffajee AD, Socransky SS, Teles RP. Effects of periodontal therapy on GCF cytokines in generalized aggressive periodontitis subjects. J Clin Periodontol. 2012 Mar;39(3):295-302. doi: 10.1111/j.1600-051X.2011.01817.x. Epub 2011 Nov 30.
Katsiki P, Nazmi K, Loos BG, Laine ML, Schaap K, Hepdenizli E, Bikker FJ, Brand HS, Veerman ECI, Nicu EA. Comparing periodontitis biomarkers in saliva, oral rinse and gingival crevicular fluid: A pilot study. J Clin Periodontol. 2021 Sep;48(9):1250-1259. doi: 10.1111/jcpe.13479. Epub 2021 Jun 20.
Dicle ALTINDAL, Associate Professor
Yuzuncu Yil University
Burak Muğdat KARAN, Assistant Professor
Yuzuncu Yil University
Zehra KAYA, Associate Professor
Yuzuncu Yil University
Elif Töre SARI CAN, Assistant Professor
Yuzuncu Yil University
First Submitted
October 12, 2026
First Posted
October 19, 2026
Study Start
October 15, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
April 2027
GCF Bax and Bcl-xl Levels in Periodontitis
IL-10 levels in saliva and GCF
Single time point at baseline (day of sample collection)
Correlation between biomarker levels and clinical periodontal parameters
Single time point at baseline (day of sample collection)
Irisin, IL-6, IL-10, and TNF-α levels measured by human-specific ELISA kits in unstimulated whole saliva and GCF samples collected.
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Khan SU, Ghafoor S, Khaliq S, Syed AR. Salivary Irisin and periodontal clinical parameters in patients of chronic periodontitis and healthy individuals: A novel salivary myokine for periodontal disease. J Pak Med Assoc. 2022 Jan;72(1):27-33. doi: 10.47391/JPMA.01367.
Pereira LJ, Andrade EF, Barroso LC, Lima RR, Macari S, Paiva SM, Silva TA. Irisin effects on bone: systematic review with meta-analysis of preclinical studies and prospects for oral health. Braz Oral Res. 2022 Apr 15;36:e055. doi: 10.1590/1807-3107bor-2022.vol36.0055. eCollection 2022.
Baeza M, Garrido M, Hernandez-Rios P, Dezerega A, Garcia-Sesnich J, Strauss F, Aitken JP, Lesaffre E, Vanbelle S, Gamonal J, Brignardello-Petersen R, Tervahartiala T, Sorsa T, Hernandez M. Diagnostic accuracy for apical and chronic periodontitis biomarkers in gingival crevicular fluid: an exploratory study. J Clin Periodontol. 2016 Jan;43(1):34-45. doi: 10.1111/jcpe.12479. Epub 2016 Feb 12.
Chapple ILC, Mealey BL, Van Dyke TE, Bartold PM, Dommisch H, Eickholz P, Geisinger ML, Genco RJ, Glogauer M, Goldstein M, Griffin TJ, Holmstrup P, Johnson GK, Kapila Y, Lang NP, Meyle J, Murakami S, Plemons J, Romito GA, Shapira L, Tatakis DN, Teughels W, Trombelli L, Walter C, Wimmer G, Xenoudi P, Yoshie H. Periodontal health and gingival diseases and conditions on an intact and a reduced periodontium: Consensus report of workgroup 1 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Periodontol. 2018 Jun;89 Suppl 1:S74-S84. doi: 10.1002/JPER.17-0719.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 23, 2026
Record last verified: 2026-10
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.
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Source: ClinicalTrials.gov.
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