Smoking BehaviorsECIG-FOXONCT07338318
Effects of E-Cigarette Use on Oxidative Stress and Matrix Degradation
An observational study of Smoking Behaviors and Periodontal Health, run by Ankara Medipol University at 1 site in Turkey (Türkiye).
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Behaviors, Periodontal Health
- What is being tested?
- E-Cigarette Use
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Apr 2025to 1 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Systemically and periodontally healthy smokers, e-cigarette users, and non-smoking individuals over 18 years old.
Who may be able to join
- E-cigarette using, conventional smokers, non-smokers
Who cannot join
- Having active periodontal disease, systemic health problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Smoking Behaviors, Periodontal Health
- Being tested
- E-Cigarette Use
- Keywords
- e-cigarette, periodontal health, matrix metalloproteinaz-9, forkhead-box protein 1
- Medical subject headings
- Smoking, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-Cigarette UseOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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, Receives: Other: E-Cigarette Use |
What is being measured
The primary outcome is the main question the study is designed to answer.
(MMP-9, ROS, FOXO-1) Concentration in GCF
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.
Measured: Single measurement at baseline (cross-sectional assessment)
Secondary outcomes (1)
correlation clinical parameters and gcf biomarkers
Clinical periodontal indices will be correlated with the expression levels of MMP-9, ROS, and foxo-1.
Measured: single time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start30 Apr 2025
- Primary completion30 Aug 2025
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking BehaviorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeliha Guney, Ankara Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07338318
- Sponsor's protocol ID
- AnkaraMedipolUni.
- Other IDs
- 16.04.2025/80
- Acronym
- ECIG-FOXO
- Status last verified
- Apr 2025
- First submitted
- 3 Jan 2026
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of E-Cigarette Use on Oxidative and Matrix-Degrading Pathways in Periodontally Healthy Tissues
- ClinicalTrials.gov ID
- NCT07338318
- Acronym / sponsor ID
- ECIG-FOXO / AnkaraMedipolUni.
- Conditions
- Smoking Behaviors, Periodontal Health
- Keywords
- e-cigarette, periodontal health, matrix metalloproteinaz-9, forkhead-box protein 1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ankara Medipol UniversityUniversity, hospital or other
- Study start
- 30 Apr 2025 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 13 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| E-Cigarette Users | – | Other: E-Cigarette UseParticipants 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, |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Systemically and periodontally healthy smokers, e-cigarette users, and non-smoking individuals over 18 years old.
Key inclusion criteria (1 listed)
- E-cigarette using, conventional smokers, non-smokers
Key exclusion criteria (1 listed)
- Having active periodontal disease, systemic health problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E-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 | Other | E-Cigarette Users |
Primary outcome
(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.
1 secondary outcome
correlation clinical parameters and gcf biomarkers
Time frame: single time point
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking Behaviors and Periodontal Health, run by Ankara Medipol University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(MMP-9, ROS, FOXO-1) Concentration in GCF (time frame: Single measurement at baseline (cross-sectional assessment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.