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Recruiting NCT07312552

Association of Periodontal Status and Smoking With Salivary Inflammasome Markers

— Observational Periodontitis Periodontal Disease Periodontal Health Smoking

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Periodontal examinations, Collection of saliva samples.
Who it may be relevant to
Registry conditions: Periodontitis, Periodontal Disease, Periodontal Health, Smoking. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

  • Diagnostic test Periodontal examinations
    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.
  • Diagnostic test Collection of saliva samples
    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 outcome measures

  • Clinical attachment level (mm) [Time frame: Baseline]
  • Probing pocket depth [Time frame: Baseline]
  • Bleeding on probing [Time frame: Baseline]
Secondary outcome measures (8)
  • Plaque percentage [Time frame: Baseline]
  • Periodontal inflammatory surface area (PISA) [Time frame: Baseline]
  • Salivary interleukin-10 (IL-10) levels [Time frame: Baseline]
  • Salivary interleukin-1beta (IL-1β) levels [Time frame: Baseline]
  • Salivary NOD-like receptor family, pyrin domain containing 3 (NLRP-3) levels [Time frame: Baseline]
  • Salivary NOD-like receptor family, pyrin domain containing 6 (NLRP-6) levels [Time frame: Baseline]
  • Salivary NOD-like receptor family, pyrin domain containing 12 (NLRP-12) levels [Time frame: Baseline]
  • Salivary NOD-like receptor family, CARD domain containing 5 (NLRC-5) levels [Time frame: Baseline]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Turkey (Türkiye) · 1 center
  • Uskudar University, Faculty of Dentistry — Istanbul

Identifiers

NCT: NCT07312552 · KKARADURAN1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗