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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 90 participants in total. It began in 2023-09-01 with a primary completion date of 2025-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Barbara Kispélyi, Dental
STUDY DIRECTOR
Semmelweis University, Department of Prosthodontics
Frequently Asked Questions
Who can join the NCT06784817 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Gingivitis and Periodontal Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06784817 currently recruiting?
Yes, NCT06784817 is actively recruiting participants. Contact the research team at vamos.orsolya@semmelweis.hu for enrollment information.
Where is the NCT06784817 trial being conducted?
This trial is being conducted at Budapest, Hungary.
Who is sponsoring the NCT06784817 clinical trial?
NCT06784817 is sponsored by Semmelweis University. The principal investigator is Barbara Kispélyi, Dental at Semmelweis University, Department of Prosthodontics. The trial plans to enroll 90 participants.