Epidemiology and Acute Oral Effects Electronic Cigarette

Semmelweis University

Status: Completed

Conditions: Nicotine Dependence, Cigarettes

Treatments: Device: ProVari v2.5 (E-cigarette); Device: Cigarette tip; Device: Marlboro Gold (Conventional cigarette)

Study type: Interventional

Funder types: Other

Identifiers

NCT03011710

epidacute-ecig-2015

Details and patient eligibility

About

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.

Full description

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)

Enrollment: 14 patients

Sex: All

Ages: 19 to 49 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• age: 19-49 years
• signed consent form
• smoking regularly e-cigarette and/or conventional cigarette for > half year

Exclusion criteria

• 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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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14 participants in 4 patient groups, including a placebo group

E-cigarette with nicotine

Experimental group

Description:

Nicotine level: 6 mg/ml

Treatment:

Device: ProVari v2.5 (E-cigarette)

E-cigarette without nicotine

Experimental group

Description:

Nicotine level: 0 mg/ml

Treatment:

Device: ProVari v2.5 (E-cigarette)

Conventional cigarette

Experimental group

Description:

Nicotine content: 0,5mg

Treatment:

Device: Marlboro Gold (Conventional cigarette)

Cigarette tip

Placebo Comparator group

Description:

Placebo device

Treatment:

Device: Cigarette tip