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Association of Periodontal Status and Smoking With Salivary Inflammasome Markers

U

Uskudar University

Status

Enrolling

Conditions

Inflammasomes
Periodontitis
Periodontal Health
Smoking
Periodontal Disease

Treatments

Diagnostic Test: Periodontal examinations
Diagnostic Test: Collection of saliva samples

Study type

Observational

Funder types

Other

Identifiers

NCT07312552
KKARADURAN1

Details and patient eligibility

About

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.

Full 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.

Enrollment

116 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

116 participants in 4 patient groups

Group 1 (C)
Description:
Healthy individuals (control (C))
Treatment:
Diagnostic Test: Collection of saliva samples
Diagnostic Test: Periodontal examinations
Group 2 (S-C)
Description:
Smokers with healthy periodontium (S-C)
Treatment:
Diagnostic Test: Collection of saliva samples
Diagnostic Test: Periodontal examinations
Group 3 (P)
Description:
Nonsmokers with Stage III/IV periodontitis (P)
Treatment:
Diagnostic Test: Collection of saliva samples
Diagnostic Test: Periodontal examinations
Group 4 (S-P)
Description:
Smokers with Stage III/IV periodontitis (S-P)
Treatment:
Diagnostic Test: Collection of saliva samples
Diagnostic Test: Periodontal examinations

Trial contacts and locations

1

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Central trial contact

Kubra KARADURAN

Data sourced from clinicaltrials.gov

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