Evaluation of the Effect of Smoking on Pyroptosis in Periodontal Pathogenesis

NCT07563192 | Active Not Recruiting

• 1 other identifier: 79-38
• Study Type: observational
• Target: 113
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis; Gingivitis; Periodontal Diseases; Smoking ( Cigarette)

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Relative mRNA expression levels of TLR1,TLR4 and TLR6

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

  Baseline (At the clinical examination)

• Protein concerntrations of NLRP3, IL-18 and IL-1β

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

  Baseline (At the time of clinical examinat

Secondary Outcomes (3)

• Periodontal Inflamed Surface Area (PISA)

  Baseline (At the time of clinical examination)

• Periodontal Clinical Measurements (PD and CAL)

  Baseline (At the time of clinical examination)

• Periodontal Indices (PI and GI)

  Baseline (At the time of clinical examination)

Study Arms (6)

Healthy Non-Smoker

Systemically healty individulas with clinically healthy periodontal tissues who have never smoked or have not smoked for least 5 years.

Gingivitis Non-Smoker

Systemically healty individulas diagnosed with gingivitis who are non-smokers.

Periodontitis Non-Smoker

Systemically healty individulas diagnosed with Stage III or IV periodontitis who are non-smokers.

Healthy Smoker

Systemically healty individulas with clinically healthy periodontal tissues who have been smoking least 10 cigarettes per day for at least 1 year.

Gingivitis Smoker

Systemically healty individulas with gingivitis who have been smoking least 10 cigarettes per day for at least 1 year.

Periodontitis Smoker

Systemically healty individulas diagnosed with Stage III or IV periodontitis who who have been smoking least 10 cigarettes per day for at least 1 year.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of individuals who applied to the Department of Periodontology at the Faculty of Dentistry. Participants include systemically healthy volunteers diagnosed with different periodontal conditions (healthy, gingivitis, or periodontitis) and categorized by their smoking status.

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Suleyman Demirel University: lead

Study Sites (1)

Suleyman Demirel University, Faculty of Dentistry, Department of Periodontology

Isparta, Isparta, 32000, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITH DNA

Gingival tissue samples are stored for RNA exratction and protein analysis. These specimens are maintained for molecular an biochemical assessments related to the study protocol.

MeSH Terms

Conditions

Periodontitis; Gingivitis; Periodontal Diseases; Cigarette Smoking

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Tobacco Smoking; Smoking; Behavior; Tobacco Use

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 11, 2026
• First Posted: May 1, 2026
• Study Start: October 15, 2024
• Primary Completion: November 18, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)