Epidemiology and Acute Oral Effects Electronic Cigarette

Not Applicable

Completed

• Conditions: Nicotine Dependence, Cigarettes
• Interventions: Device: Marlboro Gold (Conventional cigarette); Device: ProVari v2.5 (E-cigarette); Device: Cigarette tip

• Registration Number: NCT03011710
• Lead Sponsor: Semmelweis University

Brief Summary

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.

Detailed 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)

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2017-01-04
• Study First Submitted QC: 2017-01-04
• Study First Posted: 2017-01-05
• Status Verified: 2022-07
• Primary Completion: 2023-11-22
• Study Completion: 2023-11-22
• Last Update Submitted: 2023-11-23
• Last Update Posted: 2023-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional cigarette	Marlboro Gold (Conventional cigarette)	Nicotine content: 0,5mg
E-cigarette without nicotine	ProVari v2.5 (E-cigarette)	Nicotine level: 0 mg/ml
E-cigarette with nicotine	ProVari v2.5 (E-cigarette)	Nicotine level: 6 mg/ml
Cigarette tip	Cigarette tip	Placebo device

Primary Outcome Measures

Name	Time	Method
Change from baseline in blood flow after vaping/smoking	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.