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Evaluation of the Effect of Smoking on Pyroptosis in Periodontal Pathogenesis

28. april 2026 opdateret af: Meryem KOKSALAN, Suleyman Demirel University
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.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

113

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Tyrkiet (Türkiye)
    • Isparta
      • Isparta, Isparta, Tyrkiet (Türkiye), 32000
        • Suleyman Demirel University, Faculty of Dentistry, Department of Periodontology

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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.).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Relative mRNA expression levels of TLR1,TLR4 and TLR6
Tidsramme: Baseline (At the clinical examination)
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
Tidsramme: 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.
Baseline (At the time of clinical examinat

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

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Sponsor

Suleyman Demirel University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

15. oktober 2024

Primær færdiggørelse (Faktiske)

18. november 2025

Studieafslutning (Anslået)

30. juni 2026

Datoer for studieregistrering

Først indsendt

11. april 2026

Først indsendt, der opfyldte QC-kriterier

28. april 2026

Først opslået (Faktiske)

1. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 79-38

Plan for individuelle deltagerdata (IPD)

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