Investigating the Periodontal Status of Traditional and Heated Tobacco Product Users

NCT ID: NCT06784817

Last Updated: 2025-01-20

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2025-03-01

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.

Conditions

Gingivitis and Periodontal Diseases

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Non-smokers

Never consumed tobacco in any form

No interventions assigned to this group

Cigarette smokers

Smoking at least 1 cigarette daily for at least 12 months

No interventions assigned to this group

Heated tobacco product users

Using heated tobacco products e.g. IQOS exclusively at least once daily in the past 12 months and was not a regular traditional cigarette smoker

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Center for Translational Medicine

OTHER

Sponsor Role: collaborator

Semmelweis University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Barbara Kispélyi, Dental

Role: STUDY_DIRECTOR

Semmelweis University, Department of Prosthodontics

Kata Kelemen, Dental

Role: STUDY_DIRECTOR

Semmelweis University, Department of Prosthodontics

Brigitta Teutsch, Medical doctor

Role: STUDY_CHAIR

Center for Translational Medicine, Semmelweis University

Locations

Semmelweis University Department of Prosthodontics

Budapest, Pest County, Hungary

Site Status: RECRUITING

Countries

Hungary

Central Contacts

Orsolya Vámos, Dental

Role: CONTACT

vamos.orsolya@semmelweis.hu

+3614591500/59313

Facility Contacts

Orsolya Vámos, Dental

Role: primary

vamos.orsolya@semmelweis.hu

+3614591500 ext. 59313

Barbara Kispélyi, Dental

Role: backup

kispelyi.barbara@semmelweis.hu

+3614591500 ext. 59332

Other Identifiers

SE RKEB 131/2023

Identifier Type: -

Identifier Source: org_study_id