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

Not Applicable

Completed

• Conditions: Periodontal Inflammation; Mouth Diseases; Periodontal Diseases
• Interventions: Diagnostic Test: GCF obtaining; Diagnostic Test: Saliva Obtaining; Diagnostic Test: Serum obtaining

• Registration Number: NCT05435131
• Lead Sponsor: Akdeniz University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-01
• Primary Completion: 2021-01-11
• Study Completion: 2021-01-11
• Status Verified: 2022-06
• Study First Submitted: 2022-06-22
• Study First Submitted QC: 2022-06-22
• Study First Posted: 2022-06-28
• Last Update Submitted: 2022-06-29
• Last Update Posted: 2022-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Periodontal Health	GCF obtaining	Full-mouth clinical periodontal measurements recorded and GCF, saliva serum obtained.
Stage II grade B Periodontitis	GCF obtaining	Full-mouth clinical periodontal measurements recorded and GCF, saliva serum obtained.
Stage II grade B Periodontitis	Serum obtaining	Full-mouth clinical periodontal measurements recorded and GCF, saliva serum obtained.
Stage III grade B Periodontitis	GCF obtaining	Full-mouth clinical periodontal measurements recorded and GCF, saliva serum obtained.
Periodontal Health	Saliva Obtaining	Full-mouth clinical periodontal measurements recorded and GCF, saliva serum obtained.
Periodontal Health	Serum obtaining	Full-mouth clinical periodontal measurements recorded and GCF, saliva serum obtained.
Gingivitis	GCF obtaining	Full-mouth clinical periodontal measurements recorded and GCF, saliva serum obtained.
Stage II grade B Periodontitis	Saliva Obtaining	Full-mouth clinical periodontal measurements recorded and GCF, saliva serum obtained.
Stage III grade B Periodontitis	Serum obtaining	Full-mouth clinical periodontal measurements recorded and GCF, saliva serum obtained.
Stage III grade C Periodontitis	Serum obtaining	Full-mouth clinical periodontal measurements recorded and GCF, saliva serum obtained.
Stage III grade C Periodontitis	GCF obtaining	Full-mouth clinical periodontal measurements recorded and GCF, saliva serum obtained.
Gingivitis	Saliva Obtaining	Full-mouth clinical periodontal measurements recorded and GCF, saliva serum obtained.
Gingivitis	Serum obtaining	Full-mouth clinical periodontal measurements recorded and GCF, saliva serum obtained.
Stage III grade B Periodontitis	Saliva Obtaining	Full-mouth clinical periodontal measurements recorded and GCF, saliva serum obtained.
Stage III grade C Periodontitis	Saliva Obtaining	Full-mouth clinical periodontal measurements recorded and GCF, saliva serum obtained.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Akdeniz University Faculty of Dentistry; 🇹🇷 Antalya, Turkey