NCT06784817 Investigating the Periodontal Status of Traditional and Heated Tobacco Product Users
| NCT ID | NCT06784817 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Semmelweis University |
| Condition | Gingivitis and Periodontal Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 90 participants |
| Start Date | 2023-09-01 |
| Primary Completion | 2025-03-01 |
Trial Parameters
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Brief Summary
This cross-sectional observational study aims to compare the clinical and radiographic periodontal status, as well as gingival crevicular fluid volume, among cigarette smokers, heated-tobacco product users, and non-smokers. Specifically, the aim is to determine whether tobacco product users exhibit worse clinical parameters-such as probing pocket depth, bleeding on probing, plaque index, clinical attachment loss-along with greater radiographic bone loss and higher gingival crevicular fluid volume than non-smokers.
Eligibility Criteria
Inclusion Criteria: * Smokers who smoke at least one cigarette daily for the past 12 months. * Exclusive users of heated tobacco products (e.g., IQOS), using them at least once daily for the past 12 months and not regular traditional cigarette smokers. * Non-smokers who have never consumed tobacco in any form. Exclusion Criteria: * Users of electronic cigarettes, smokeless tobacco, waterpipes, or any other tobacco products. * Dual users of tobacco products. * Individuals diagnosed with systemic diseases. * Edentulousness or severe tooth loss (fewer than 20 remaining teeth). * Individuals who have taken antibiotics, steroids, or non-steroidal anti-inflammatory drugs in the past 90 days. * Pregnant or breastfeeding women. * History of periodontitis. * Individuals refusing to sign the written informed consent form. * Third molars are excluded from examination.