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

NCT ID: NCT04777487

Last Updated: 2021-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2019-09-25

Brief 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.

Conditions

Periodontal Diseases

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Healthy Periodontium

Full-mouth clinical periodontal measurements recorded and GCF obtained.

Group Type: EXPERIMENTAL

GCF obtaining

Intervention Type: DIAGNOSTIC_TEST

4 samples of gingival crevicular fluid, 1 from each quadrant of the patient's jaw, were collected by means of paper strips.

Gingivitis

Full-mouth clinical periodontal measurements recorded and GCF obtained.

Group Type: EXPERIMENTAL

GCF obtaining

Intervention Type: DIAGNOSTIC_TEST

4 samples of gingival crevicular fluid, 1 from each quadrant of the patient's jaw, were collected by means of paper strips.

Periodontitis

Full-mouth clinical periodontal measurements recorded and GCF obtained.

Group Type: EXPERIMENTAL

GCF obtaining

Intervention Type: DIAGNOSTIC_TEST

4 samples of gingival crevicular fluid, 1 from each quadrant of the patient's jaw, were collected by means of paper strips.

Interventions

GCF obtaining

4 samples of gingival crevicular fluid, 1 from each quadrant of the patient's jaw, were collected by means of paper strips.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Izmir Katip Celebi University

OTHER

Sponsor Role: lead

Responsible Party

Hazal Akkaya

Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mehmet Sağlam

Role: STUDY_DIRECTOR

Izmir Katip Çelebi University

Locations

Izmir Katip Çelebi University Department of Periodontology

Izmir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2019-TDU-DİŞF-0008

Identifier Type: -

Identifier Source: org_study_id