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

Periodontal Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05435131
• Other study ID #: Hkorkmaz
• Status: Completed
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: January 11, 2021

Study information

• Verified date: June 2022
• Source: Akdeniz University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: January 11, 2021
• Est. primary completion date: January 11, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Mouth Diseases
• Periodontal Diseases
• Periodontal Inflammation

Intervention

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
• Saliva Obtaining
Saliva obtaining: 1,5 ml unstimulated whole saliva collected from each participant
• Serum obtaining
Serum obtaining : 8 ml of venous blood was collected from each participant and collecting blood centrifuged to obtain serum

Locations

Country	Name	City	State
Turkey	Akdeniz University Faculty of Dentistry	Antalya

Sponsors (1)

Lead Sponsor	Collaborator
Akdeniz University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Levels of Interleukin-38 (pg/ml) in GCF, saliva and serum fluid		24 hours after taking the clinical measurements at the first visit
Primary	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	Levels of Interleukin-17 (pg/ml) in GCF, saliva and serum fluid		24 hours after taking the clinical measurements at the first visit
Secondary	Levels of Matrix Metalloproteinase-9 (ng/ml) in GCF, saliva and serum fluid		24 hours after taking the clinical measurements at the first visit