NCT07338318

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 30, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 13, 2026

Completed
Last Updated

January 13, 2026

Status Verified

April 1, 2025

Enrollment Period

4 months

First QC Date

January 3, 2026

Last Update Submit

January 3, 2026

Conditions

Keywords

e-cigaretteperiodontal healthmatrix metalloproteinaz-9forkhead-box protein 1

Outcome Measures

Primary Outcomes (1)

  • (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.

    Single measurement at baseline (cross-sectional assessment)

Secondary Outcomes (1)

  • correlation clinical parameters and gcf biomarkers

    single time point

Study Arms (1)

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

Interventions

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

E-Cigarette Users

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Having active periodontal disease, systemic health problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Medipol Uni.

Ankara, Ankara, 06570, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITH DNA

Gingival crevicular fluid

MeSH Terms

Conditions

SmokingVaping

Interventions

Electronic Nicotine Delivery Systems

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Smoking DevicesManufactured MaterialsTechnology, Industry, and Agriculture

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate prof.

Study Record Dates

First Submitted

January 3, 2026

First Posted

January 13, 2026

Study Start

April 30, 2025

Primary Completion

August 30, 2025

Study Completion

October 1, 2025

Last Updated

January 13, 2026

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

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

Locations