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Association of Periodontal Status and Smoking With Salivary Inflammasome Markers

NCT ID: NCT07312552

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

116 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-23

Study Completion Date

2026-07-31

Brief Summary

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The aim of this study is to evaluate the relationship between periodontal status and salivary levels of the inflammasomes NLRP-3, NLRP-6, NLRP-12, and NLRC-5, as well as the cytokines IL-1β and 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

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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 ELISA method.

Conditions

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Periodontitis Periodontal Disease Periodontal Health Smoking Inflammasomes

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Group 1 (C)

Healthy individuals (control (C))

Periodontal examinations

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

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 ELISA method.

Group 2 (S-C)

Smokers with healthy periodontium (S-C)

Periodontal examinations

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

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 ELISA method.

Group 3 (P)

Nonsmokers with Stage III/IV periodontitis (P)

Periodontal examinations

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

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 ELISA method.

Group 4 (S-P)

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

Periodontal examinations

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

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 ELISA method.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Collection of saliva samples

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 ELISA method.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Uskudar University

OTHER

Sponsor Role lead

Responsible Party

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Kubra Karaduran

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kubra KARADURAN

Role: PRINCIPAL_INVESTIGATOR

Uskudar University

Locations

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Uskudar University, Faculty of Dentistry

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Kubra KARADURAN

Role: CONTACT

Phone: +905395913683

Email: [email protected]

Other Identifiers

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KKARADURAN1

Identifier Type: -

Identifier Source: org_study_id