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Epidemiology and Acute Oral Effects Electronic Cigarette

Epidemiology and Acute Oral Effects of Electronic Cigarette

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03011710
Enrollment
14
Registered
2017-01-05
Start date
2015-09-30
Completion date
2023-11-22
Last updated
2023-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nicotine Dependence, Cigarettes

Keywords

e-cigarette, blood flow, oral effects, oral pH

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)

Interventions

DEVICEProVari v2.5 (E-cigarette)

An electronic cigarette or e-cigarette is a handheld electronic device that vaporizes a flavored liquid. The user inhales the vapor. The fluid in the e-cigarette, called e-liquid, is usually made of nicotine, propylene glycol, glycerine, and flavorings.

Conventional cigarette

DEVICECigarette tip

Placebo device

Sponsors

Semmelweis University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to 49 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline in blood flow after vaping/smokingbaseline, immediately after smoking/vaping, and 15 minutes after smoking/vapingThe blood flow changes are measured by Laser Speckle Contrast Analyzer (LASCA) before (baseline) and after vaping/smoking.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026