Evaluation of Biomarker Levels in Gingival Crevicular Fluid of Patients With Different Periodontal Diseases

Periodontal Diseases Clinical Trial

Official title:

Evaluation of Peptidyl Arginine Deiminase 4 (PAD4), Galectin-3 and TNF-α Levels in Gingival Crevicular Fluid of Patients With Different Periodontal Diseases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04777487
• Other study ID #: 2019-TDU-DISF-0008
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: September 25, 2019

Study information

• Verified date: March 2021
• Source: Izmir Katip Celebi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Objectives: The aim of this study is; detection of peptidyl arginine deiminase4 (PAD4), galectin-3 and tumor necrosis factor alpha (TNF-α) levels in gingival crevicular fluid (GCF) 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 of GCF were obtained from 60systemically healthy non-smoker individuals with periodontitis (P, n=20), gingivitis(G, n=20) and healthy periodontium (S, n=20). 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 PAD4, galectin-3 and TNF-α levels in the biological samples.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 25, 2019
• Est. primary completion date: September 25, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 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

• For the periodontitis group; According to the evaluation made in 6 regions of each tooth, individuals with 30% or more bleeding on probing area, at least 2 teeth not adjacent to each quarter jaw with a depth of 5 mm or more and 4 mm or more attachment loss, coronal 1/3 and more on radiography (horizontal and / or vertical) bone loss

• For the gingivitis group; According to the evaluation made in 6 regions of each tooth, individuals with 10% or more bleeding on probing area, having a probing depth of less than 4mm and no attachment loss

• For healthy group; According to the evaluation made in 6 regions of each tooth,individuals with less than 10% bleeding on probing area, having a probing depth less than 4mm and no loss of attachment were included in the study.

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 are not included in the study

Related Conditions & MeSH terms

• Periodontal Diseases

Intervention

Diagnostic Test:
• GCF obtaining
4 samples of gingival crevicular fluid, 1 from each quadrant of the patient's jaw, were collected by means of paper strips.

Locations

Country	Name	City	State
Turkey	Izmir Katip Çelebi University Department of Periodontology	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Izmir Katip Celebi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The total amount of Galectin-3 in GCF	The total amount of Galectin-3 in GCF	24 hours after taking the clinical measurements at the first visit
Primary	The total amount of PAD4 in GCF	The total amount of PAD4 in GCF	24 hours after taking the clinical measurements at the first visit
Secondary	The total amount of TNF-a in GCF	The total amount of TNF-a in GCF	24 hours after taking the clinical measurements at the first visit