Investigating the Periodontal Status of Traditional and Heated Tobacco Product Users: A Cross-sectional Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Marginal bone loss in mm ( MBL)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Marginal bone loss in mm ( MBL)
时间窗: At baseline (first visit)
Digital periapical radiographs will be taken of each tooth and be viewed on a calibrated computer screen using a software program. MBL is defined as the vertical distance from 2 mm below the cemento-enamel junction (CEJ) to the most crestal part of marginal alveolar bone. Measures of effect: mean and standard deviation
次要结局
- Gingival Crevicular Fluid (GCF) volume in μL(At baseline (first visit))
- Full mouth plaque index (PI)(At baseline (first visit))
- Bleeding on Probing (BOP)(At baseline (first visit))
- Probing Pocket Depth (PPD)(At baseline (first visit))
- Clinical attachment level (CAL)(At baseline (first visit))