Effects of E-Cigarette Use on Oxidative Stress and Matrix Degradation (ECIG-FOXO)

January 3, 2026 updated by: Zeliha Guney, Ankara Medipol University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Ankara
      • Ankara, Ankara, Turkey (Türkiye), 06570
        • Ankara Medipol Uni.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Systemically and periodontally healthy smokers, e-cigarette users, and non-smoking individuals over 18 years old.

Description

Inclusion Criteria:

  • E-cigarette using, conventional smokers, non-smokers

Exclusion Criteria:

  • Having active periodontal disease, systemic health problems

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
E-Cigarette Users
Participants who have used electronic cigarettes exclusively for at least 12 months, with no history of conventional cigarette use during that period. Eligible individuals must report daily vaping habits and nicotine-containing e-liquid use. All participants will present with clinically healthy periodontal tissues,
Other: E-Cigarette Use
Exclusive 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
(MMP-9, ROS, FOXO-1) Concentration in GCF
Time Frame: Single measurement at baseline (cross-sectional assessment)
MMP-9, ROS, FOXO-1 levels will be quantified using a commercially available enzyme-linked immunosorbent assay (ELISA) to assess proteolytic activity in periodontally healthy individuals. The mean MMP-9, ROS, and FOXO-1 concentrations (ng/mL) will be compared among three groups: exclusive e-cigarette users, conventional smokers, and non-smokers.
Single measurement at baseline (cross-sectional assessment)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
correlation clinical parameters and gcf biomarkers
Time Frame: single time point
Clinical periodontal indices will be correlated with the expression levels of MMP-9, ROS, and foxo-1.
single time point

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ankara Medipol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 30, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 3, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 3, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AnkaraMedipolUni.
  • 16.04.2025/80 (Other Identifier: Ankara Medipol University Non-Interventional Clinical Research Ethics Committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared. Only summary and aggregated data relevant to the study outcomes will be published in scientific journals or presented at academic meetings. Data sharing beyond this is not planned due to participant confidentiality and ethical restrictions set by the Ankara Medipol University Non-Interventional Clinical Research Ethics Committee

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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