NCT07457892

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 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

May 20, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 9, 2026

Completed
Last Updated

March 9, 2026

Status Verified

March 1, 2026

Enrollment Period

8 months

First QC Date

March 3, 2026

Last Update Submit

March 3, 2026

Conditions

Keywords

Nicotine DependenceFagerström Test for Nicotine DependencePeriodontal Disease AwarenessSmokingPeriodontal ParametersCross-Sectional Study

Outcome Measures

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.

    Baseline

Secondary Outcomes (4)

  • Maximum Probing Depth (PDmax)

    Baseline

  • Maximum Clinical Attachment Loss (CALmax)

    Baseline

  • Bleeding on Probing (BOP)

    Baseline

  • Fagerström Test for Nicotine Dependence Score (FTND)

    Baseline

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erzincan Binali Yıldırım University Faculty of Dentistry

Erzincan, Province, 24100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontal DiseasesGingivitisPeriodontitisTobacco Use DisorderSmoking

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesInfectionsGingival DiseasesSubstance-Related DisordersChemically-Induced DisordersMental DisordersBehavior

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Erzincan Binali Yıldırım University Faculty of Dentistry

Study Record Dates

First Submitted

March 3, 2026

First Posted

March 9, 2026

Study Start

May 20, 2025

Primary Completion

January 16, 2026

Study Completion

January 16, 2026

Last Updated

March 9, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations