Actively Recruiting
Investigating Gum and Periodontal Health in Users of Traditional Cigarettes and Heated Tobacco Products: A Cross-Sectional Observational Study
Led by Semmelweis University · Updated on 2025-01-20
90
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
Sponsors
S
Semmelweis University
Lead Sponsor
C
Center for Translational Medicine
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to compare the periodontal health of cigarette smokers, heated tobacco product users, and non-smokers to understand if tobacco users have worse clinical and radiographic periodontal conditions. The study focuses on clinical parameters such as probing pocket depth, bleeding on probing, plaque index, clinical attachment loss, radiographic bone loss, and gingival crevicular fluid volume. It is a cross-sectional observational study conducted at the Department of Prosthodontics at Semmelweis University, Budapest, Hungary. Participants include cigarette smokers who smoke at least one cigarette daily, exclusive heated tobacco product users who use these devices daily and are not regular cigarette smokers, and non-smokers who have never used any tobacco. The study does not involve any treatment or intervention but compares these groups based on their periodontal status and gingival crevicular fluid volume. During the study, patients will undergo clinical and radiographic examinations to measure periodontal health indicators and gingival crevicular fluid volume. Outcomes include assessing marginal bone loss at baseline and evaluating differences among the groups. The study excludes third molars from examination and collects data from patients enrolled at the university's prosthodontics department.
CONDITIONS
Official Title
Investigating the Periodontal Status of Traditional and Heated Tobacco Product Users
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
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Trial Site Locations
Total: 1 location
1
Semmelweis University Department of Prosthodontics
Budapest, Pest County, Hungary, 1088
Actively Recruiting
Research Team
O
Orsolya Vámos, Dental
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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