Comparing periodontal health in smokers, heated tobacco users, and non-smokers
Investigating the Periodontal Status of Traditional and Heated Tobacco Product Users: A Cross-sectional Observational Study
This study is testing if smoking traditional cigarettes or using heated tobacco products leads to worse gum health compared to non-smokers.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Semmelweis University Academic / other |
| Locations | 1 site (Budapest, Pest County) |
| Trial ID | NCT06784817 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the periodontal health of individuals who smoke traditional cigarettes, use heated tobacco products, and those who do not smoke at all. It will evaluate clinical parameters such as probing pocket depth, bleeding on probing, plaque index, clinical attachment loss, and radiographic bone loss, along with measuring gingival crevicular fluid volume. The study seeks to determine if tobacco product users have worse periodontal health compared to non-smokers, addressing a gap in existing literature regarding the effects of heated tobacco products on oral health.
Who should consider this trial
Good fit: Ideal candidates include daily smokers, exclusive heated tobacco product users, and non-smokers who have never used tobacco.
Not a fit: Patients who use electronic cigarettes, smokeless tobacco, or have a history of periodontitis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the oral health risks associated with heated tobacco products, potentially guiding public health recommendations.
How similar studies have performed: While one previous study has looked at periodontal health in heated tobacco users, this study is novel as it focuses on users without a history of traditional cigarette smoking.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Budapest, Pest County
- Semmelweis University Department of Prosthodontics — Budapest, Pest County, Hungary (Recruiting)
Study contacts
- Study coordinator: Orsolya Vámos, Dental
- Email: vamos.orsolya@semmelweis.hu
- Phone: +3614591500/59313
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.