NCT06784817

Investigating the Periodontal Status of Traditional and Heated Tobacco Product Users

Investigating the Periodontal Status of Traditional and Heated Tobacco Product Users: A Cross-sectional Observational Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 90 (estimated)
• Sponsor: Semmelweis University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Timeline

• Start date: 2023-09-01
• Primary completion: 2025-03-01
• Completion: 2025-03-01
• First posted: 2025-01-20
• Last updated: 2025-01-20

Locations

1 site across 1 country: Hungary