Clinical Trials Directory

Trials / Completed

CompletedNCT07338318

Effects of E-Cigarette Use on Oxidative Stress and Matrix Degradation

Effects of E-Cigarette Use on Oxidative and Matrix-Degrading Pathways in Periodontally Healthy Tissues

Status
Completed
Phase
Study type
Observational
Enrollment
60 (actual)
Sponsor
Ankara Medipol University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

Summary

This cross-sectional observational study aims to investigate the effects of e-cigarette use on oxidative and matrix-degrading pathways in periodontally healthy individuals. Gingival crevicular fluid biomarkers, including matrix metalloproteinase-9 (MMP-9), reactive oxygen species (ROS), and forkhead-box-1 (FOXO1), will be analyzed to compare the biochemical and inflammatory responses among three groups: e-cigarette users, conventional cigarette smokers, and non-smokers. The study seeks to clarify whether e-cigarette use induces subclinical inflammatory or proteolytic activity in oral tissues comparable to that of traditional smoking.

Detailed description

Cigarette smoking is a well-established risk factor for periodontal tissue destruction, primarily through oxidative stress and upregulation of proteolytic enzymes such as matrix metalloproteinases (MMPs). The advent of electronic cigarettes (e-cigarettes) has introduced an alternative nicotine delivery system, often perceived as less harmful due to the absence of combustion. However, the biological effects of e-cigarette aerosols on oral and periodontal tissues remain unclear. Matrix metalloproteinase-9 (MMP-9) and reactive oxygen species (ROS) are key enzymes involved in extracellular matrix degradation and the regulation of oxidative stress, respectively. Both biomarkers are found in gingival crevicular fluid (CGF) and are elevated during inflammatory conditions, including periodontitis and peri-implant diseases. Evidence suggests that conventional cigarette smoking increases salivary MMP-9 and ROS levels, reflecting enhanced oxidative and enzymatic tissue breakdown. Whether similar alterations occur in exclusive e-cigarette users with clinically healthy periodontal tissues remains to be determined. The ECIG study is a cross-sectional, observational clinical investigation designed to evaluate oxidative and matrix-degrading pathways in periodontally healthy individuals across three groups: e-cigarette users, conventional smokers, and non-smokers. GCF samples will be collected to assess biochemical markers, including MMP-9, ROS, and total antioxidant capacity, using ELISA-based methods. Standardized periodontal parameters (plaque index, gingival index, probing depth, and clinical attachment level) will be recorded to confirm periodontal health status. This study aims to test the hypothesis that exclusive e-cigarette use induces measurable oxidative and proteolytic activity in GCF, comparable to that observed in conventional smokers, despite the absence of clinical periodontal inflammation. Understanding these mechanisms may provide valuable insights into the subclinical impact of vaping on oral health and contribute to public health discussions regarding the relative safety of e-cigarette use.

Conditions

Interventions

TypeNameDescription
OTHERE-Cigarette UseExclusive e-cigarette users for at least 12 consecutive months, with no conventional cigarette or other tobacco product use during that period. Participants report daily vaping of nicotine-containing e-liquids using refillable or disposable e-cigarette devices. The group represents chronic exposure to aerosolized nicotine and flavoring agents without combustion products

Timeline

Start date
2025-04-30
Primary completion
2025-08-30
Completion
2025-10-01
First posted
2026-01-13
Last updated
2026-01-13

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07338318. Inclusion in this directory is not an endorsement.