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Completed

NCT Number: NCT04777487

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

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.

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Key information

Conditions

Periodontal Diseases Mouth Diseases Stomatognathic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Izmir Katip Çelebi University Department of Periodontology

Izmir, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. The total amount of Galectin-3 in GCF

    Time frame: 24 hours after taking the clinical measurements at the first visit

    The total amount of Galectin-3 in GCF

  2. The total amount of PAD4 in GCF

    Time frame: 24 hours after taking the clinical measurements at the first visit

    The total amount of PAD4 in GCF

Secondary outcomes

  1. The total amount of TNF-α in GCF

    Time frame: 24 hours after taking the clinical measurements at the first visit

    The total amount of TNF-α in GCF

Sponsors and collaborators

Lead sponsor

Izmir Katip Celebi University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 2, 2021
Registry last updated
Mar 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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