Clinical trial NCT06784817: Investigating the Periodontal Status of Traditional and Heated Tobacco Product Users
Official title: Investigating the Periodontal Status of Traditional and Heated Tobacco Product Users: A Cross-sectional Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gingivitis and Periodontal Diseases
Keywords: smoking
heated tobacco products
periodontal diseases
Lead sponsor: Semmelweis University
Sponsor class: OTHER
Collaborators: name: Center for Translational Medicine
First posted: 2025-01-20
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy induviduals with no systemic diseases will be selected for this study.

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.

Detailed description: Smoking is one of the main risk factors of periodontitis and its harmful effects on periodontal health are now well known. Thanks to worldwide restrictions, the use of traditional cigarettes is declining, but new alternative tobacco products such as heated tobacco products (e.g. IQOS, glo) have appeared on the market. These devices are often perceived less harmful by consumers, but there are conflicting results in the literature regarding their health effects.

Only one study has assessed periodontal health in heated tobacco product users, but in this study all participants were former smokers. No studies have evaluated periodontal health in heated tobacco users without a history of smoking traditional cigarettes on a regular basis.

Therefore, the aim of the present cross-sectional observational study is to compare the clinical and radiographic periodontal status and gingival crevicular fluid (GCF) volume among cigarette-smokers, heated-tobacco product users and non-smokers.

The null hypothesis is that different tobacco product users have worse clinical and radiological periodontal parameters and higher GCF volume than non-smokers.

The study will be performed at the Department of Prosthodontics at Semmelweis University, Budapest, Hungary. Patients will be enrolled from the patient material of the Department of Prosthodontics.

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.

Primary outcomes:
measure: Marginal bone loss in mm ( MBL)
timeFrame: At baseline (first visit)
Secondary outcomes:
measure: Full mouth plaque index (PI)
timeFrame: At baseline (first visit)
measure: Bleeding on Probing (BOP)
timeFrame: At baseline (first visit)
measure: Probing Pocket Depth (PPD)
timeFrame: At baseline (first visit)
measure: Clinical attachment level (CAL)
timeFrame: At baseline (first visit)
measure: Gingival Crevicular Fluid (GCF) volume in μL
timeFrame: At baseline (first visit)
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Semmelweis University Department of Prosthodontics
state: Pest
Study officials:
affiliation: Semmelweis University, Department of Prosthodontics
name: Barbara Kispélyi, Dental
role: STUDY_DIRECTOR
affiliation: Semmelweis University, Department of Prosthodontics
name: Kata Kelemen, Dental
role: STUDY_DIRECTOR
affiliation: Center for Translational Medicine, Semmelweis University
name: Brigitta Teutsch, Medical doctor
role: STUDY_CHAIR
References: