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Completed

NCT Number: NCT07201142

Gingival Crevicular Fluid and Salivary Levels of GDF-15, Smad2, Smad5, Smad6, and IL-6 in Patients With Periodontitis

The dysregulation of the transforming growth factor-beta signaling pathway can lead to inflammation and tissue destruction in the pathogenesis of periodontitis. This study aims to evaluate the levels of GDF-15, Smad 2, Smad 5, Smad 6, and IL-6 in gingival crevicular fluid (GCF) and saliva between individuals with periodontitis and periodontal healthy controls and to evaluate the relationship of these biomarkers with clinical periodontal parameters. This study aims to investigate the levels of GDF-15, Smad2, Smad5, Smad6, and IL-6 in GCF and saliva samples from individuals with periodontitis and periodontally healthy controls, as well as to assess the associations of these biomarkers with clinical periodontal parameters. A total of 44 systemically healthy individuals, including 22 patients diagnosed with stage III/grade B periodontitis and 22 periodontal healthy individuals, were included in the study. Clinical periodontal parameters (plaque index (PI), probing depth (PD), clinical attachment level (CAL), and bleeding on probing (BOP)) were recorded. GDF-15, Smad 2, Smad 5, Smad 6, and IL-6 levels in saliva and GCF were analyzed using the ELISA method.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medipol University

Istanbul, 34810, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • being over 18 years of age;
  • having at least 20 natural teeth excluding third molars;
  • being systemically healthy

Exclusion criteria

  • under 18 years of age;
  • had used antibiotics
  • had used nonsteroidal anti-inflammatory drugs, corticosteroids, immunosuppressants, beta-blockers, calcium channel blockers, anticoagulants, or hormonal contraceptives within the past 6 months;
  • had systemic diseases such as diabetes mellitus, rheumatoid arthritis, cardiovascular diseases, epilepsy, renal or hepatic disorders, or viral infections like HIV/AIDS;
  • pregnant or breastfeeding;
  • current smokers or had a history of alcoholism;
  • had received nonsurgical periodontal therapy within the last 6 months or surgical periodontal treatment within the last 12 months;
  • had fewer than 20 natural teeth (excluding third molars);
  • had fixed orthodontic appliances.

Treatment and study plan

Primary outcomes

  1. GCF GDF-15, GCF IL-6, GCF SMAD 2, GCF Smad 5, GCF Smad 6

    Time frame: September 2023 to February 2024

  2. Saliva GDF-15, Saliva IL-6, Saliva SMAD 2, Saliva Smad 5, Saliva Smad 6,

    Time frame: September 2023 to Februart-y 2024

Sponsors and collaborators

Lead sponsor

Melis Yilmaz

Other

Collaborators

  • Medipol University

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 1, 2025
Registry last updated
Oct 1, 2025

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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