Epidemiology and Acute Oral Effects of Electronic Cigarette
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 主要终点
- Change from baseline in blood flow after vaping/smoking
研究概览
简要总结
Electronic cigarettes are battery-powered vaporizers which have a similar feel to tobacco smoking. They do not produce cigarette smoke but rather an aerosol, which is frequently referred to as vapor. E-cigarettes are marketed as less harmful alternatives to smoking. Use and awareness of these devices has grown exponentially in recent years, with millions of people currently using them.
The benefits and risks of electronic cigarette use are uncertain. There is no research on the acute oral effects of electronic cigarette in the scientific literature and no hungarian epidemiological survey has been performed in this topic.
Regulation of electronic cigarettes varies across countries in the European Union, ranging from no regulation to banning them entirely.
The investigators research could help to integrate the regulation of this device in Hungary and in the EU as well.
The measurement of acute oral effects of e-cigarette and a hungarian epidemiological survey would be novel in this topic.
详细描述
The epidemiological survey is performed with online questionnaires, which are published on e-cigarette-selling websites and on other forums dealing with this topic.
The main outcome of interest was whether or not e-cigarette use helped people to quit smoking or reduce the number of conventional cigarettes. Participants were also asked about the reason for starting e-cigarette use. Nationality, habitation, citizenship status were included as demographic predictors in analyses.
Measurements of acute oral effects before and after using electronic cigarette with nicotine, without nicotine, conventional cigarette and placebo device:
- measurement of exhaled CO changes by Smokerlyzer piCO
- measurement of saliva MMP-8 by PerioSafe Home
- measurement of saliva pH, buffering capacity, and flow rate changes by Saliva Check Buffer Kit (GC)
- measurement of oral mucosal blood flow changes by Perilam PSI System High Resolution (LASCA method)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age: 19-49 years
- •signed consent form
- •smoking regularly e-cigarette and/or conventional cigarette for > half year
排除标准
- •not pregnant and not planning pregnancy in the next 6 month
- •BMI index < 30
- •no severe parodontal disease
- •no acute illness in the last 2 weeks
- •no chronic disease (eg.: diabetes)
- •no diet which can influence the oral pH
结局指标
主要结局
Change from baseline in blood flow after vaping/smoking
时间窗: baseline, immediately after smoking/vaping, and 15 minutes after smoking/vaping
The blood flow changes are measured by Laser Speckle Contrast Analyzer (LASCA) before (baseline) and after vaping/smoking.
次要结局
未报告次要终点