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Evaluation of the Effect of Smoking on Pyroptosis in Periodontal Pathogenesis

Evaluation of the Effect of Smoking on Pyroptosis in Periodontal Pathogenesis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07563192
Enrollment
113
Registered
2026-05-01
Start date
2024-10-15
Completion date
2026-06-30
Last updated
2026-05-01

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

Conditions

Gingivitis, Periodontal Diseases, Periodontitis, Smoking ( Cigarette)

Keywords

pyroptosis, NLRP3 Inflammasome, Interleukin-1 beta ( IL-1β), Interleukin-18 (IL-18), Cigarette Smoking, TLR1, TLR4, TLR6

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

Suleyman Demirel University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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.).

Design outcomes

Primary

MeasureTime frameDescription
Relative mRNA expression levels of TLR1,TLR4 and TLR6Baseline (At the clinical examination)Metric:Fold change (2\^-ΔΔCt method). Measurement of gene expression levels in gingival tissues using the RT-PCR method.
Protein concerntrations of NLRP3, IL-18 and IL-1βBaseline (At the time of clinical examinatMetric: Picograms per milliliter (pg/mL). Evaluation of protein concentrations in gingival tissue samples using the ELISA method.

Secondary

MeasureTime frameDescription
Periodontal Inflamed Surface Area (PISA)Baseline (At the time of clinical examination)Metric: square millimeters (mm²). Calculation of the total periodontal inflamed surface area to quantify the inflammatory burden.
Periodontal Clinical Measurements (PD and CAL)Baseline (At the time of clinical examination)Metric: millimeters (mm). Measurements of Probing Depth (PD) and Clinical Attachment Level (CAL) using a periodontal probe.
Periodontal Indices (PI and GI)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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 2, 2026