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CompletedNCT07457892Updated Mar 9, 2026

Nicotine Dependence, Periodontal Awareness, and Clinical Periodontal Parameters in Smokers With Gingivitis and Periodontitis

An observational study in Periodontal Disease, Gingivitis and Periodontal Diseases and Periodontitis, sponsored by Erzincan University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-03-09.

Sponsored by Erzincan University · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
350
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This cross-sectional observational study aims to evaluate the association between nicotine dependence and periodontal disease awareness in individuals diagnosed with gingivitis or periodontitis. While the relationship between cigarette smoking and periodontal disease has been extensively investigated, most previous studies have focused primarily on quantitative smoking exposure measures such as the number of cigarettes smoked per day or smoking duration. In contrast, nicotine dependence represents a behavioral dimension of smoking that may influence how individuals perceive and interpret health-related symptoms.

Nicotine dependence will be assessed using the Fagerström Test for Nicotine Dependence (FTND). Periodontal disease awareness will be determined through patient-reported responses regarding their perception of periodontal health. In addition, clinical periodontal parameters including plaque index, bleeding on probing (BOP), probing depth (PD), and clinical attachment loss (CAL) will be recorded during routine periodontal examination.

The primary objective of this study is to investigate whether nicotine dependence level is associated with periodontal disease awareness. Secondary analyses will explore the relationships between nicotine dependence and clinical periodontal parameters to better understand potential mechanisms that may influence awareness patterns in smokers.

Read the detailed description

Cigarette smoking is a well-established risk factor for periodontal disease and has been associated with increased periodontal destruction and impaired healing responses. However, smoking may also influence the perception and recognition of periodontal disease symptoms. Previous periodontal research has primarily evaluated smoking exposure using quantitative measures such as daily cigarette consumption and duration of smoking. These measures may not fully capture the behavioral and psychological aspects of nicotine addiction.

Nicotine dependence represents a behavioral component of smoking behavior that may affect how individuals perceive symptoms and respond to disease-related changes in their oral health. The Fagerström Test for Nicotine Dependence (FTND) is a validated instrument widely used to quantify nicotine addiction levels. Despite its extensive use in smoking research, the relationship between nicotine dependence and periodontal disease awareness has received limited attention in periodontal literature.

The present study is designed as a cross-sectional observational investigation conducted among individuals diagnosed with gingivitis or periodontitis. Participants will be recruited from patients attending a periodontal clinic. After obtaining informed consent, participants will complete the FTND questionnaire and a brief questionnaire assessing periodontal disease awareness.

A comprehensive periodontal examination will be performed by an experienced periodontist. Clinical parameters including plaque index, bleeding on probing (BOP), maximum probing depth (PD), and maximum clinical attachment loss (CAL) will be recorded using standardized periodontal probes.

The primary aim of the study is to evaluate whether nicotine dependence level is associated with periodontal disease awareness. Secondary analyses will examine associations between nicotine dependence and clinical periodontal parameters, including PD, CAL, and BOP, in order to explore potential pathways linking nicotine dependence with periodontal disease perception.

By introducing nicotine dependence as a behavioral measure of smoking exposure, this study aims to provide a new perspective on the relationship between smoking and periodontal disease awareness. The findings may contribute to improved periodontal screening strategies and patient education approaches for individuals with higher nicotine dependence.

02

Conditions studied

  • Periodontal Disease
  • Gingivitis and Periodontal Diseases
  • Periodontitis

Keywords

  • Nicotine Dependence
  • Fagerström Test for Nicotine Dependence
  • Periodontal Disease Awareness
  • Smoking
  • Periodontal Parameters
  • Cross-Sectional Study
03

In context

Periodontal Diseases

830 studies on the registry are indexed under Periodontal Diseases; 188 are open to participants now.

This study's enrollment of 350 is above the median of 100 across 291 observational studies indexed under Periodontal Diseases.

Browse Periodontal Diseases studies →

Lead sponsor

Erzincan University is the lead sponsor of 42 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Participants were adult smokers diagnosed with gingivitis or periodontitis who attended or were referred to the Department of Periodontology at Erzincan Binali Yıldırım University Faculty of Dentistry. Some individuals presented directly for periodontal complaints, while others were referred from other dental departments during routine dental care. Participants were consecutively recruited and evaluated for periodontal disease awareness and nicotine dependence.

Inclusion criteria

  • Individuals aged 18 years or older
  • Current smokers
  • Diagnosis of gingivitis or periodontitis according to periodontal clinical examination
  • Ability to complete the Fagerström Test for Nicotine Dependence questionnaire
  • Provided informed consent to participate in the study

Exclusion criteria

Exclusion Criteria:

  • Individuals with systemic diseases known to affect periodontal tissues
  • History of periodontal treatment within the previous 6 months
  • Use of medications that may influence periodontal status
  • Pregnancy or lactation
  • Inability to complete the study questionnaire
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
350 participants (actual)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • Periodontal Disease Aware

    Participants diagnosed with gingivitis or periodontitis who reported being aware of having periodontal disease.

  • Periodontal Disease Unaware

    Participants diagnosed with gingivitis or periodontitis who reported not being aware of having periodontal disease.

06

What researchers measure

Primary outcomes

  1. Periodontal Disease Awareness

    Self-reported awareness of having periodontal disease among individuals diagnosed with gingivitis or periodontitis, determined through participant responses during clinical examination.

    Time frame: Baseline

Secondary outcomes

  1. Maximum Probing Depth (PDmax)

    Maximum periodontal probing depth recorded during full-mouth periodontal examination using a standardized periodontal probe.

    Time frame: Baseline

  2. Maximum Clinical Attachment Loss (CALmax)

    Maximum clinical attachment loss measured at any tooth site during periodontal examination.

    Time frame: Baseline

  3. Bleeding on Probing (BOP)

    Percentage of bleeding sites recorded during periodontal probing.

    Time frame: Baseline

  4. Fagerström Test for Nicotine Dependence Score (FTND)

    Nicotine dependence level measured using the Fagerström Test for Nicotine Dependence questionnaire.

    Time frame: Baseline

07

Study locations

1 site
  • Erzincan Binali Yıldırım University Faculty of Dentistry
    Erzincan, Province 24100, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07457892
Lead sponsor
Erzincan University
Responsible party
Ömer Faruk Okumuş (Erzincan Binali Yıldırım University Faculty of Dentistry, Erzincan University) — Principal investigator
First posted
Mar 9, 2026
Start date
May 20, 2025
Primary completion
Jan 16, 2026
Completion
Jan 16, 2026
Last update
Mar 9, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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