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

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

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.

Study Overview

• Status: Completed
• Conditions: Periodontal Diseases; Mouth Diseases; Periodontal Inflammation
• Intervention / Treatment: Diagnostic test: GCF obtaining; Diagnostic test: Saliva Obtaining; Diagnostic test: Serum obtaining

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Antalya, Turkey, 07070
    • Akdeniz University Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

5

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Akdeniz University

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2020
• Primary Completion (ACTUAL): January 11, 2021
• Study Completion (ACTUAL): January 11, 2021

Study Registration Dates

• First Submitted: June 22, 2022
• First Submitted That Met QC Criteria: June 22, 2022
• First Posted (ACTUAL): June 28, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 1, 2022
• Last Update Submitted That Met QC Criteria: June 29, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Stomatognathic Diseases; Inflammation; Mouth Diseases; Periodontal Diseases
• Other Study ID Numbers: Hkorkmaz

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No