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Completed

NCT Number: NCT05435131

Evaluation of Biomarkers Levels in Gingival Crevicular Fluid, Saliva and Serum for Different Periodontal Diseases

The aim of this study is; detection of interleukin(IL)-38, IL-36 gamma(γ) , IL-17 and matrix metalloproteinase(MMP)-9 levels in gingival crevicular fluid (GCF), saliva and serum 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 were obtained from 90 systemically healthy non-smoker individuals with periodontitis (P, n=30), gingivitis(G, n=30) and healthy periodontium (S, n=30). 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 IL-38, IL-36γ, IL-17 and MMP-9 levels in the biological samples.

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Key information

Conditions

Mouth Diseases Periodontal Diseases Periodontal Inflammation Stomatognathic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Akdeniz University Faculty of Dentistry

Antalya, 07070, 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

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

Treatment and study plan

GCF obtaining

Diagnostic Test

GCF obtaining: 2 GCF samples, 1 from the interproximal surface of 2 different teeth that bleeding on probing(-), were taken from each participant

saliva obtaining

Diagnostic Test

Saliva obtaining: 1,5 ml unstimulated whole saliva collected from each participant

Serum obtaining

Diagnostic Test

Serum obtaining : 8 ml of venous blood was collected from each participant and collecting blood centrifuged to obtain serum

Primary outcomes

  1. Levels of Interleukin-38 (pg/ml) in GCF, saliva and serum fluid

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

  2. Levels of Interleukin-36 gamma (pg/ml) in GCF, saliva and serum fluid

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

Secondary outcomes

  1. Levels of Interleukin-17 (pg/ml) in GCF, saliva and serum fluid

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

  2. Levels of Matrix Metalloproteinase-9 (ng/ml) in GCF, saliva and serum fluid

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

Sponsors and collaborators

Lead sponsor

Akdeniz University

Other

Registry information

Official study title

Evaluation of Interleukin (IL)-38, IL-36-gamma, IL-17 and Matrix Metalloproteinase-9 Levels in Gingival Crevicular Fluid, Saliva and Serum for Periodontal Health, Gingivitis and Periodontitis

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 28, 2022
Registry last updated
Jul 1, 2022

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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