Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07563192

Evaluation of the Effect of Smoking on Pyroptosis in Periodontal Pathogenesis

This study investigates the impact of smoking on pyroptosis and inflammatory signaling pathways in systemically healthy individuals with various periodontal conditions. The research compares smokers and non-smokers across three clinical categories, resulting in six study groups: Healthy Control, Gingivitis, and Periodontitis. The study specifically evaluates the levels of IL-1beta, IL-18, and NLRP3 through ELISA, and the gene expression of TLR1, TLR4, and TLR6 through RT-PCR, to understand how cigarette smoke modulates innate immune responses in the absence of other systemic diseases.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Periodontitis Behavior Cigarette Smoking Gingival Diseases Gingivitis Infections Mouth Diseases Periodontal Diseases Smoking Smoking ( Cigarette) Stomatognathic Diseases Tobacco Smoking Tobacco Use

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Suleyman Demirel University, Faculty of Dentistry, Department of Periodontology

Isparta, 32000, Turkey (Türkiye)

About this study

The aim of this research is to clarify the molecular link between tobacco use and pyroptotic cell death pathways in the pathogenesis of periodontal disease. To eliminate systemic bias, only systemically healthy participants are included. The study design consists of 6 distinct groups based on a 2x3 matrix (Smoking Status: Yes/No × Periodontal Status: Healthy/Gingivitis/Periodontitis).

Protein levels of the NLRP3 inflammasome and pro-inflammatory cytokines (IL-1beta, IL-18) are measured in periodontal tissues using the ELISA method. Furthermore, the mRNA expressions of Toll-like receptors (TLR1, TLR4, and TLR6) are analyzed via RT-PCR. These findings will help determine how smoking influences tissue destruction mechanisms specifically through the pyroptosis pathway in different stages of gum disease.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Individuals who voluntarily agreed to participate in the study,
  • Smokers (gingivitis and stage 3/4 generalized periodontitis) and non-smokers (gingivitis and stage 3/4 generalized periodontitis) who applied to the Periodontology Clinical of Suleyman Demirel University Faculty of Dentistry,
  • Individuals without any systemic diseases and without using any medications that affect periodontal health were included.

Exclusion criteria

  • Individuals who refuse to participate in the study or who cannot comply with the study protocol,
  • Individuals participating in another clinical trial concurrently, Individuals who have received periodontal treatment within the last 6 months,
  • Individuals who have used medications (antibiotics, anti-inflammatory drugs, etc.) that may affect periodontal parameters within the last 3 months,
  • Individuals with systemic diseases that may affect the periodontium,
  • Individuals with systemic diseases presenting with oral symptoms,
  • Individuals with malignant disease,
  • Pregnant or lactating women,
  • Individuals with psychological or physical disabilities,
  • Individuals with substance abuse,
  • Individuals with severe malocclusion, undergoing orthodontic treatment, using appliances, or using removable dentures,
  • Individuals with acute dental infection or pain (cavities, abscesses, etc.).

Treatment and study plan

Primary outcomes

  1. Relative mRNA expression levels of TLR1,TLR4 and TLR6

    Time frame: Baseline (At the clinical examination)

    Metric:Fold change (2^-ΔΔCt method). Measurement of gene expression levels in gingival tissues using the RT-PCR method.

  2. Protein concerntrations of NLRP3, IL-18 and IL-1β

    Time frame: Baseline (At the time of clinical examinat

    Metric: Picograms per milliliter (pg/mL). Evaluation of protein concentrations in gingival tissue samples using the ELISA method.

Secondary outcomes

  1. Periodontal Inflamed Surface Area (PISA)

    Time frame: Baseline (At the time of clinical examination)

    Metric: square millimeters (mm²). Calculation of the total periodontal inflamed surface area to quantify the inflammatory burden.

  2. Periodontal Clinical Measurements (PD and CAL)

    Time frame: Baseline (At the time of clinical examination)

    Metric: millimeters (mm). Measurements of Probing Depth (PD) and Clinical Attachment Level (CAL) using a periodontal probe.

  3. Periodontal Indices (PI and GI)

    Time frame: Baseline (At the time of clinical examination)

    Metric: 0-3 numerical scale. Assessment of Plaque Index (PI) and Gingival Index (GI) to evaluate oral hygiene and gingival inflammation.

Sponsors and collaborators

Lead sponsor

Suleyman Demirel University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
May 1, 2026
Registry last updated
May 1, 2026

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.