Periodontal status, smoking, and salivary inflammasome markers
The Impact of Periodontal Status and Smoking on Salivary Inflammasome Levels: A Cross-Sectional Study
This trial will test whether levels of salivary inflammasome proteins (NLRP-3, NLRP-6, NLRP-12, NLRC-5, IL-1β and IL-10) differ between people with and without periodontitis and whether smoking changes those levels.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 116 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Uskudar University Academic / other |
| Locations | 1 site (Istanbul) |
| Trial ID | NCT07312552 on ClinicalTrials.gov |
What this trial studies
This observational study compares salivary inflammasome and cytokine levels across four groups: smokers with periodontitis, non-smokers with periodontitis, smokers without periodontitis, and non-smokers without periodontitis. Participants receive medical and dental history review, full intraoral and periodontal examinations according to the 2017 AAP/EFP classification, and unstimulated saliva collection prior to clinical measurements. Saliva samples are stored at −80°C and later analyzed by ELISA to quantify NLRP-3, NLRP-6, NLRP-12, NLRC-5, IL-1β and IL-10. The study aims to determine whether these salivary markers can serve as noninvasive diagnostic indicators of periodontitis and whether smoking modulates their associations with periodontal status.
Who should consider this trial
Good fit: Ideal candidates are systemically healthy adults with at least 20 teeth who are clinically periodontally healthy or have periodontitis and who are either current smokers or non-smokers without recent antibiotics or periodontal treatment.
Not a fit: People with diabetes, rheumatoid arthritis, recent antibiotic or periodontal therapy, current medications that affect gingival health, pregnancy or lactation, heavy alcohol use, or fewer than 20 teeth are unlikely to qualify or benefit from this study.
Why it matters
Potential benefit: If successful, the findings could support simple saliva-based tests to help identify periodontitis and clarify how smoking affects oral inflammatory markers.
How similar studies have performed: Previous work has shown that salivary cytokines such as IL-1β can distinguish periodontal disease with modest accuracy, but measuring NLRP family inflammasome proteins in saliva is less established and remains exploratory.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Istanbul
- Uskudar University, Faculty of Dentistry — Istanbul, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: Kubra KARADURAN — Uskudar University
- Study coordinator: Kubra KARADURAN
- Email: kubra95krdrn@gmail.com
- Phone: +905395913683
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.