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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04777487
Enrollment
60
Registered
2021-03-02
Start date
2019-04-01
Completion date
2019-09-25
Last updated
2021-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontal Diseases

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.

Interventions

DIAGNOSTIC_TESTGCF obtaining

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

Sponsors

Izmir Katip Celebi University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

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).

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
The total amount of PAD4 in GCF24 hours after taking the clinical measurements at the first visitThe total amount of PAD4 in GCF
The total amount of Galectin-3 in GCF24 hours after taking the clinical measurements at the first visitThe total amount of Galectin-3 in GCF

Secondary

MeasureTime frameDescription
The total amount of TNF-α in GCF24 hours after taking the clinical measurements at the first visitThe total amount of TNF-α in GCF

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026