Association of Periodontal Status and Smoking With Salivary Inflammasome Markers

NCT07312552 | Recruiting

• 1 other identifier: KKARADURAN1
• Study Type: observational
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis; Periodontal Disease; Periodontal Health; Smoking; Inflammasomes

Outcome Measures

Primary Outcomes (3)

• Clinical attachment level (mm)

  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.

  Baseline

• Probing pocket depth

  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.

  Baseline

• Bleeding on probing

  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%).

  Baseline

Secondary Outcomes (8)

• Plaque percentage

  Baseline

• Periodontal inflammatory surface area (PISA)

  Baseline

• Salivary interleukin-10 (IL-10) levels

  Baseline

• Salivary interleukin-1beta (IL-1β) levels

  Baseline

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

  Baseline

Study Arms (4)

Group 1 (C)

Healthy individuals (control (C))

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

Group 2 (S-C)

Smokers with healthy periodontium (S-C)

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

Group 3 (P)

Nonsmokers with Stage III/IV periodontitis (P)

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

Group 4 (S-P)

Smokers with Stage III/IV periodontitis (S-P)

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

Interventions

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.

Group 1 (C); Group 2 (S-C); Group 3 (P); Group 4 (S-P)

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).

Group 1 (C); Group 2 (S-C); Group 3 (P); Group 4 (S-P)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will consist of four groups: Group 1: healthy individuals (control (C)), Group 2: smokers with healthy periodontium (S-C), Group 3: nonsmokers with Stage III/IV periodontitis (P), Group 4: smokers with Stage III/IV periodontitis (S-P)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Uskudar University: lead

Study Sites (1)

Uskudar University, Faculty of Dentistry

Istanbul, Turkey (Türkiye)

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Unstimulated whole saliva samples will be collected from all participants. Samples will be stored at -80°C until analysis.The stored saliva samples will be used exclusively for the measurement of biomarker levels via ELISA. No DNA extraction or genetic analyses will be conducted.

MeSH Terms

Conditions

Periodontitis; Periodontal Diseases; Smoking

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Behavior

Study Officials

• Kubra KARADURAN

  Uskudar University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kubra KARADURAN

CONTACT

+905395913683; kubra95krdrn@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: December 31, 2025
• Study Start: December 23, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

TU (1)