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

NCT04777487 | Completed

• 1 other identifier: 2019-TDU-DİŞF-0008
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• The total amount of TNF-α in GCF

  24 hours after taking the clinical measurements at the first visit

Study Arms (3)

Healthy Periodontium

EXPERIMENTAL

Full-mouth clinical periodontal measurements recorded and GCF obtained.

Diagnostic Test: GCF obtaining

Gingivitis

EXPERIMENTAL

Full-mouth clinical periodontal measurements recorded and GCF obtained.

Diagnostic Test: GCF obtaining

Periodontitis

EXPERIMENTAL

Full-mouth clinical periodontal measurements recorded and GCF obtained.

Diagnostic Test: GCF obtaining

Interventions

GCF obtaining 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; Healthy Periodontium; Periodontitis

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Izmir Katip Celebi University: lead

Study Sites (1)

Izmir Katip Çelebi University Department of Periodontology

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Mehmet Sağlam

  Izmir Katip Çelebi University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: According to full-mouth clinical periodontal measurements including probing depth (PD), clinical attachment level (CAL),bleeding on probing (BOP), gingival index (GI) and plaque index (PI) samples of GCF were obtained from 60 systemically healthy non-smoker individuals with periodontitis (P, n=20), gingivitis(G, n=20) and healthy periodontium (S, n=20).

Study Record Dates

• First Submitted: February 27, 2021
• First Posted: March 2, 2021
• Study Start: April 1, 2019
• Primary Completion: September 25, 2019
• Study Completion: September 25, 2019
• Last Updated: March 2, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

TU (1)