Evaluation of Biomarkers Levels in Gingival Crevicular Fluid, Saliva and Serum for Different Periodontal Diseases

Study Overview
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Brief Summary
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The aim of this study is; detection of interleukin(IL)-38, IL-36 gamma(γ) , IL-17 and matrix metalloproteinase(MMP)-9 levels in gingival crevicular fluid (GCF), saliva and serum samples of periodontally healthy, gingivitis and periodontitis patients and the possible correlation between these values and clinical parameters of periodontal diseases. Materials and methods: Samples were obtained from 90 systemically healthy non-smoker individuals with periodontitis (P, n=30), gingivitis(G, n=30) and healthy periodontium (S, n=30). Full-mouth clinical periodontal measurements including probing depth (PD), clinical attachment level (CAL), bleeding on probing (BOP), gingival index (GI) and plaque index (PI) were also recorded. Enzyme-linked immunosorbent assay (ELISA) was used to determine IL-38, IL-36γ, IL-17 and MMP-9 levels in the biological samples.

Official Title
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Evaluation of Interleukin (IL)-38, IL-36-gamma, IL-17 and Matrix Metalloproteinase-9 Levels in Gingival Crevicular Fluid, Saliva and Serum for Periodontal Health, Gingivitis and Periodontitis

Conditions
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Mouth Diseases, Periodontal Inflammation, Periodontal Diseases

Intervention / Treatment
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* Diagnostic Test: GCF obtaining
* Diagnostic Test: Saliva Obtaining
* Diagnostic Test: Serum obtaining


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Systemically healthy (The determination of healthy volunteers will be based on the statements of the patients in the anamnesis. No additional examinations will be made.) At least twenty permanent teeth in the mouth Non-smoker No medication for continuous use Those who have not used antibiotics, anti-inflammatory and systemic corticosteroid drugs in the last 6 months. Not in pregnancy or lactation period. For the periodontitis group that has not received periodontal treatment in the last 6 months Exclusion Criteria: Any oral or systemic disease Regularly using a systemic medication During pregnancy or lactation Received periodontal treatment within the last 6 months. Those who received antibiotic, anti-inflammatory or systemic corticosteroid medication in the last 6 months Smokers

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: According to full-mouth clinical periodontal measurements including probing depth (PD), clinical attachment level (CAL),bleeding on probing (BOP), gingival index (GI) and plaque index (PI) samples of GCF, saliva and serum were obtained from 90 systemically healthy non-smoker individuals with stage II grade B (P1, n=9), stage III grade B (P2, n=11) , stage III grade C (n=10), gingivitis (G, n=30) and healthy periodontium (S, n=30).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Periodontal Health<br>Full-mouth clinical periodontal measurements recorded and GCF, saliva serum obtained. | Diagnostic Test: GCF obtaining<br>* GCF obtaining: 2 GCF samples, 1 from the interproximal surface of 2 different teeth that bleeding on probing(-), were taken from each participant<br>Diagnostic Test: Saliva Obtaining<br>* Saliva obtaining: 1,5 ml unstimulated whole saliva collected from each participant<br>Diagnostic Test: Serum obtaining<br>* Serum obtaining : 8 ml of venous blood was collected from each participant and collecting blood centrifuged to obtain serum<br>|
| Experimental: Gingivitis<br>Full-mouth clinical periodontal measurements recorded and GCF, saliva serum obtained. | Diagnostic Test: GCF obtaining<br>* GCF obtaining: 2 GCF samples, 1 from the interproximal surface of 2 different teeth that bleeding on probing(-), were taken from each participant<br>Diagnostic Test: Saliva Obtaining<br>* Saliva obtaining: 1,5 ml unstimulated whole saliva collected from each participant<br>Diagnostic Test: Serum obtaining<br>* Serum obtaining : 8 ml of venous blood was collected from each participant and collecting blood centrifuged to obtain serum<br>|
| Experimental: Stage II grade B Periodontitis<br>Full-mouth clinical periodontal measurements recorded and GCF, saliva serum obtained. | Diagnostic Test: GCF obtaining<br>* GCF obtaining: 2 GCF samples, 1 from the interproximal surface of 2 different teeth that bleeding on probing(-), were taken from each participant<br>Diagnostic Test: Saliva Obtaining<br>* Saliva obtaining: 1,5 ml unstimulated whole saliva collected from each participant<br>Diagnostic Test: Serum obtaining<br>* Serum obtaining : 8 ml of venous blood was collected from each participant and collecting blood centrifuged to obtain serum<br>|
| Experimental: Stage III grade B Periodontitis<br>Full-mouth clinical periodontal measurements recorded and GCF, saliva serum obtained. | Diagnostic Test: GCF obtaining<br>* GCF obtaining: 2 GCF samples, 1 from the interproximal surface of 2 different teeth that bleeding on probing(-), were taken from each participant<br>Diagnostic Test: Saliva Obtaining<br>* Saliva obtaining: 1,5 ml unstimulated whole saliva collected from each participant<br>Diagnostic Test: Serum obtaining<br>* Serum obtaining : 8 ml of venous blood was collected from each participant and collecting blood centrifuged to obtain serum<br>|
| Experimental: Stage III grade C Periodontitis<br>Full-mouth clinical periodontal measurements recorded and GCF, saliva serum obtained. | Diagnostic Test: GCF obtaining<br>* GCF obtaining: 2 GCF samples, 1 from the interproximal surface of 2 different teeth that bleeding on probing(-), were taken from each participant<br>Diagnostic Test: Saliva Obtaining<br>* Saliva obtaining: 1,5 ml unstimulated whole saliva collected from each participant<br>Diagnostic Test: Serum obtaining<br>* Serum obtaining : 8 ml of venous blood was collected from each participant and collecting blood centrifuged to obtain serum<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of Interleukin-38 (pg/ml) in GCF, saliva and serum fluid |  | 24 hours after taking the clinical measurements at the first visit | 
| Levels of Interleukin-36 gamma (pg/ml) in GCF, saliva and serum fluid |  | 24 hours after taking the clinical measurements at the first visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of Interleukin-17 (pg/ml) in GCF, saliva and serum fluid |  | 24 hours after taking the clinical measurements at the first visit | 
| Levels of Matrix Metalloproteinase-9 (ng/ml) in GCF, saliva and serum fluid |  | 24 hours after taking the clinical measurements at the first visit |