Periodontal DiseaseNCT07457892
Nicotine Dependence, Periodontal Awareness, and Clinical Periodontal Parameters in Smokers With Gingivitis and Periodontitis
An observational study of Periodontal Disease and Gingivitis and Periodontal Diseases, run by Erzincan University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Periodontal Disease, Gingivitis and Periodontal Diseases, Periodontitis
- How many people
- 350 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 May 2025to 16 Jan 2026
- How long will I take part?
- 1 Day
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Erzincan Binali Yıldırım University Faculty of Dentistry
Erzincan, Province, 24100
About this study
Official title: Association Between Fagerström Nicotine Dependence Score, Periodontal Disease Awareness, and Clinical Periodontal Parameters in Individuals With Gingivitis or Periodontitis: A Cross-Sectional Study
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.
- Keywords
- Nicotine Dependence, Fagerström Test for Nicotine Dependence, Periodontal Disease Awareness, Smoking, Periodontal Parameters, Cross-Sectional Study
- Medical subject headings
- Periodontal Diseases, Gingivitis, Periodontitis, Tobacco Use Disorder, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periodontal Disease Awareness
Self-reported awareness of having periodontal disease among individuals diagnosed with gingivitis or periodontitis, determined through participant responses during clinical examination.
Measured: Baseline
Secondary outcomes (4)
Maximum Probing Depth (PDmax)
Maximum periodontal probing depth recorded during full-mouth periodontal examination using a standardized periodontal probe.
Measured: Baseline
Maximum Clinical Attachment Loss (CALmax)
Maximum clinical attachment loss measured at any tooth site during periodontal examination.
Measured: Baseline
Bleeding on Probing (BOP)
Percentage of bleeding sites recorded during periodontal probing.
Measured: Baseline
Fagerström Test for Nicotine Dependence Score (FTND)
Nicotine dependence level measured using the Fagerström Test for Nicotine Dependence questionnaire.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start20 May 2025
- Primary completion16 Jan 2026
- Study completion16 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseaseStudies 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
- 350 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Erzincan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ömer Faruk Okumuş, Erzincan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07457892
- Sponsor's protocol ID
- EBYU-Awareness-2026
- Status last verified
- Mar 2026
- First submitted
- 3 Mar 2026
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Fagerström Nicotine Dependence Score, Periodontal Disease Awareness, and Clinical Periodontal Parameters in Individuals With Gingivitis or Periodontitis: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07457892
- Acronym / sponsor ID
- EBYU-Awareness-2026
- Keywords
- Nicotine Dependence, Fagerström Test for Nicotine Dependence, Periodontal Disease Awareness, Smoking, Periodontal Parameters, Cross-Sectional Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Erzincan UniversityUniversity, hospital or other
- Study start
- 20 May 2025 (actual)
- Primary completion
- 16 Jan 2026 (actual)
- Study completion
- 16 Jan 2026 (actual)
- First posted
- 9 Mar 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 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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Periodontal Disease Awareness
Time frame: Baseline
Self-reported awareness of having periodontal disease among individuals diagnosed with gingivitis or periodontitis, determined through participant responses during clinical examination.
4 secondary outcomes
Maximum Probing Depth (PDmax)
Time frame: Baseline
Maximum Clinical Attachment Loss (CALmax)
Time frame: Baseline
Bleeding on Probing (BOP)
Time frame: Baseline
Fagerström Test for Nicotine Dependence Score (FTND)
Time frame: Baseline
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 9 Mar 2026.
- Individual participant dataSharing planned: No
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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 Periodontal Disease and Gingivitis and Periodontal Diseases, run by Erzincan 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 5 inclusion and 5 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 9 Mar 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?
Periodontal Disease Awareness (time frame: Baseline). 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 9 Mar 2026.