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Association of Periodontal Status and Smoking With Salivary Inflammasome Markers

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07312552
Enrollment
116
Registered
2025-12-31
Start date
2025-12-23
Completion date
2026-07-01
Last updated
2026-01-21

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

Conditions

Periodontitis, Periodontal Disease, Periodontal Health, Smoking, Inflammasomes

Brief summary

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.

Detailed description

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.

Interventions

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.

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).

Sponsors

Uskudar 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

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Clinical attachment level (mm)BaselineClinical 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.
Probing pocket depthBaselineMeasurement 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.
Bleeding on probingBaselineThe 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

MeasureTime frameDescription
Plaque percentageBaselineThe 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%).
Periodontal inflammatory surface area (PISA)BaselineIt is the calculation of the area of ulcerated periodontal pockets showing bleeding on probing based on the periodontal epithelial surface area.
Salivary interleukin-10 (IL-10) levelsBaselineSaliva 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.
Salivary interleukin-1beta (IL-1β) levelsBaselineSaliva 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.
Salivary NOD-like receptor family, pyrin domain containing 3 (NLRP-3) levelsBaselineSaliva 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.
Salivary NOD-like receptor family, pyrin domain containing 6 (NLRP-6) levelsBaselineSaliva 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.
Salivary NOD-like receptor family, pyrin domain containing 12 (NLRP-12) levelsBaselineSaliva 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.
Salivary NOD-like receptor family, CARD domain containing 5 (NLRC-5) levelsBaselineSaliva 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.

Countries

Turkey (Türkiye)

Contacts

CONTACTKubra KARADURAN
kubra95krdrn@gmail.com+905395913683
PRINCIPAL_INVESTIGATORKubra KARADURAN

Uskudar University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026