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NCT Number: NCT07312552

Association of Periodontal Status and Smoking With Salivary Inflammasome Markers

The aim of this study is to evaluate the relationship between periodontal status and salivary levels of the inflammasomes NOD-like receptor family, pyrin domain containing 3 (NLRP-3), NOD-like receptor family, pyrin domain containing 6 (NLRP-6), NOD-like receptor family, pyrin domain containing 12 (NLRP-12), NOD-like receptor family, CARD domain containing 5 (NLRC-5), interleukin-1 beta (IL-1β) and interleukin-10 (IL-10). Furthermore, this study aims to investigate whether the salivary levels of these inflammasomes may serve as potential diagnostic biomarkers for distinguishing individuals with periodontitis from those without. In addition, the potential role of smoking in modulating the relationship between periodontal status and salivary inflammasome levels will also be explored.

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Key information

Conditions

Periodontitis Behavior Inflammasomes Mouth Diseases Periodontal Disease Periodontal Diseases Periodontal Health Smoking Stomatognathic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Uskudar University, Faculty of Dentistry

Istanbul, Turkey (Türkiye)

Location status: Recruiting

About this study

The aim of this study was to determine the periodontal status and smoking status of the participants, to obtain clinical periodontal records and to explain their relationship with salivary NLRP-3 NLRP-6, NLRP-12, NLRC-5, IL-1β and IL-10 levels.

The participants included in the study will be divided into four groups: smokers with periodontal disease, non-smokers with periodontal disease, smokers without periodontal disease, and non-smokers without periodontal disease. Systemic and dental anamnesis of the participants will be taken, smoking habits will be evaluated, medical records and current diagnoses will be examined, intraoral examinations will be performed and periodontal records will be taken. The periodontal status of the participants will be diagnosed according to the 'Classification of Periodontal and Peri-implant Diseases and Conditions' accepted at the 2017 World Workshop, supported by the American Academy of Periodontology (AAP) and the European Federation of Periodontology (EFP).

Saliva samples will be collected before clinical periodontal measurements. The collected saliva samples will be stored at -80°C until analyzed. Salivary NLRP-3, NLRP-6, NLRP-12, NLRC-5, IL1β, and IL-10 levels will be measured using an enzyme-linked immunosorbent assay (ELISA) method.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • systemically healthy,
  • clinical diagnosis of periodontitis,
  • clinical diagnosis of periodontal health

Exclusion criteria

  • history of regular use of systemic antibiotics, anti-inflammatory, or antioxidant drugs (previous 6 months);
  • nonsurgical periodontal treatment (previous 6 months);
  • surgical periodontal treatment (previous 12 months);
  • presence of <20 teeth;
  • current medications affecting gingival health (calcium channel blockers, phenytoin, cyclosporine, and hormone replacement therapy);
  • diabetes diagnosis; rheumatoid arthritis diagnosis; and pregnancy, lactating, or excessive alcohol consumption.

Treatment and study plan

Periodontal examinations

Diagnostic Test

With periodontal evaluation, plaque percentage, probing pocket depth, percentage of bleeding on probing, clinical attachment level, number of teeth, periodontal inflammatory surface area (PISA) parameters are recorded.

Collection of saliva samples

Diagnostic Test

Levels of salivary NOD-like receptor family, pyrin domain containing 3 (NLRP-3), NOD-like receptor family, pyrin domain containing 6 (NLRP-6), NOD-like receptor family, pyrin domain containing 12 (NLRP-12), NOD-like receptor family, CARD domain containing 5 (NLRC-5), interleukin-1 beta (IL-1β), and interleukin-10 (IL-10) will be determined using an enzyme-linked immunosorbent assay (ELISA).

Primary outcomes

  1. Clinical attachment level (mm)

    Time frame: Baseline

    Clinical attachment level (CAL) is a more reliable indicator of periodontal support around a tooth than probing depth alone, as it is measured from a fixed anatomical landmark-the cementoenamel junction (CEJ)-which remains constant over time.

    Calculating CAL requires two measurements: the distance from the gingival margin to the CEJ and the probing depth.

    In cases of gingival recession, CAL is calculated by adding the probing depth to the distance from the gingival margin to the CEJ.

    In cases of gingival overgrowth, CAL is determined by subtracting the distance from the gingival margin to the CEJ from the probing depth.

  2. Probing pocket depth

    Time frame: Baseline

    Measurement of the depth of a sulcus or periodontal pocket determined by measuring distance from a gingival margin to the base of the sulcus or pocket with a calibrated periodontal probe.

  3. Bleeding on probing

    Time frame: Baseline

    The number obtained by dividing the sum of the positive areas by the sum of the examined areas is multiplied by 100 and the value obtained is expressed as the percentage of bleeding at probing (BOP%).

Secondary outcomes

  1. Plaque percentage

    Time frame: Baseline

    The presence or absence of plaque is determinant, recorded as (+) in the presence of plaque or (-) in the absence of plaque, and the percentage of the entire mouth affected by plaque is expressed as a percentage (P%).

  2. Periodontal inflammatory surface area (PISA)

    Time frame: Baseline

    It is the calculation of the area of ulcerated periodontal pockets showing bleeding on probing based on the periodontal epithelial surface area.

  3. Salivary interleukin-10 (IL-10) levels

    Time frame: Baseline

    Saliva samples will be collected prior to clinical periodontal measurements. The collected saliva samples will be stored at -80°C until analysis. Il-10 levels in saliva will be measured using the enzyme-linked immunosorbent assay (ELISA) method.

  4. Salivary interleukin-1beta (IL-1β) levels

    Time frame: Baseline

    Saliva samples will be collected prior to clinical periodontal measurements. The collected saliva samples will be stored at -80°C until analysis. IL-1β levels in saliva will be measured using the ELISA method.

  5. Salivary NOD-like receptor family, pyrin domain containing 3 (NLRP-3) levels

    Time frame: Baseline

    Saliva samples will be collected prior to clinical periodontal measurements. The collected saliva samples will be stored at -80°C until analysis. NLRP-3 levels in saliva will be measured using the ELISA method.

  6. Salivary NOD-like receptor family, pyrin domain containing 6 (NLRP-6) levels

    Time frame: Baseline

    Saliva samples will be collected prior to clinical periodontal measurements. The collected saliva samples will be stored at -80°C until analysis. NLRP-6 levels in saliva will be measured using the ELISA method.

  7. Salivary NOD-like receptor family, pyrin domain containing 12 (NLRP-12) levels

    Time frame: Baseline

    Saliva samples will be collected prior to clinical periodontal measurements. The collected saliva samples will be stored at -80°C until analysis. NLRP-12 levels in saliva will be measured using the ELISA method.

  8. Salivary NOD-like receptor family, CARD domain containing 5 (NLRC-5) levels

    Time frame: Baseline

    Saliva samples will be collected prior to clinical periodontal measurements. The collected saliva samples will be stored at -80°C until analysis. NLRC-5 levels in saliva will be measured using the ELISA method.

Study contacts

Contact information is provided by the study sponsor or research team.

Kubra KARADURAN

CONTACT

[email protected]

+905395913683

Sponsors and collaborators

Lead sponsor

Uskudar University

Other

Registry information

Official study title

The Impact of Periodontal Status and Smoking on Salivary Inflammasome Levels: A Cross-Sectional Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 31, 2025
Registry last updated
Jan 21, 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.

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