Periodontal HealthNCT07881406
Salivary and GCF Biomarkers in Periodontal Health, Gingivitis and Periodontitis
An observational study of Periodontal Health and Gingivitis, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Health, Gingivitis, Periodontitis
- What is being tested?
- Clinical periodontal examination and ELISA-based biomarker analysis
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2026to Jul 2027
- Phase
- Observational
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: 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).
Who may be able to join
- 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
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- 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 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.
Who cannot join
- 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.)
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- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Van Yuzuncu Yil University, Faculty of Dentistry
Van, Van, 65040
About this study
Official title: Comparison of Irisin, IL-6, IL-10, and TNF-α Levels in Saliva and Gingival Crevicular Fluid in Periodontal Health, Gingivitis and Periodontitis
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.
Read the detailed description
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.
- Conditions
- Periodontal Health, Gingivitis, Periodontitis
- Being tested
- Clinical periodontal examination, ELISA-based biomarker analysis
- Keywords
- Interleukin-6 (IL-6), Interleukin-10 (IL-10), TNF-alpha, Gingival crevicular fluid, Saliva, Irisin
- Medical subject headings
- Gingivitis, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical periodontal examinationDiagnostic test
Full-mouth periodontal examination including PD, CAL, BOP, plaque index, and gingival index, performed by a single calibrated examiner.
ELISA-based biomarker analysisDiagnostic test
Irisin, IL-6, IL-10, and TNF-α levels measured by human-specific ELISA kits in unstimulated whole saliva and GCF samples collected.
| Study group | Role | What they receive |
|---|---|---|
| Periodontal Health | Systemically healthy individuals with bleeding on probing (BOP) <10%, probing depth (PD) ≤3 mm, and no interdental clinical attachment loss (CAL). Receives: Diagnostic Test: Clinical periodontal examination; Diagnostic Test: ELISA-based biomarker analysis | |
| Gingivitis | Systemically healthy individuals with BOP ≥10%, PD ≤3 mm, and no interdental CAL, not meeting criteria for periodontitis. Receives: Diagnostic Test: Clinical periodontal examination; Diagnostic Test: ELISA-based biomarker analysis | |
| 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. Receives: Diagnostic Test: Clinical periodontal examination; Diagnostic Test: ELISA-based biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Single time point at baseline (day of sample collection)
Secondary outcomes (3)
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
Measured: 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
Measured: 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.
Measured: Single time point at baseline (day of sample collection)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start15 Oct 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Periodontal HealthStudies of the same condition, open and under way.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Tore Sari Can, Yuzuncu Yil University
- Investigators
- Dicle ALTINDAL, Associate Professor, Study chair, Yuzuncu Yil UniversityBurak Muğdat KARAN, Assistant Professor, Study chair, Yuzuncu Yil UniversityZehra KAYA, Associate Professor, Study chair, Yuzuncu Yil UniversityElif Töre SARI CAN, Assistant Professor, Principal investigator, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07881406
- Sponsor's protocol ID
- 2026/07-59
- Other IDs
- Project ID:13541
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 22126282Katsiki 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.
PubMed 33998029Khan 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.
PubMed 35099433Pereira 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.
PubMed 35442384Baeza 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.
PubMed 26556177Chapple 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.
PubMed 29926944