Periodontal DiseasesTRSPSNCT07295756
The Role of Smoking in Periodontal Status
An observational study of Periodontal Diseases, run by Tuğba ŞAHİN at 1 site in Turkey (Türkiye).
Trial summary
484 patients were asked whether they currently smoked and whether they had smoked 100 or more cigarettes during their lifetime. Based on this information, they were divided into two groups: current smokers (test group, n=242) and non-smokers (control group, n=242). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- Intervention
- How many people
- 484 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2025to 2 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study includes patients who are smokers and those who are non-smokers.
Who may be able to join
- Age 18 years or older
- No systemic diseases that could affect periodontal or general health
- No history of periodontal treatment within the past six months
- For the non-smoker group: abstinence from smoking for at least five years
Who cannot join
- Use of antibiotics or anti-inflammatory drugs
- Pregnant or lactating women
- Diabetes mellitus
- Use of waterpipe or chewing tobacco (for the smoker group)
- Individuals undergoing chemotherapy or radiotherapy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bolu Abant Izzet Baysal University, Dentistry Faculty
Bolu, 14030
About this study
Official title: The Role of Smoking Habits in Periodontal Health and Disease: A Cross-Sectional Study
484 patients were asked whether they currently smoked and whether they had smoked 100 or more cigarettes during their lifetime. Based on this information, they were divided into two groups: current smokers (test group, n=242) and non-smokers (control group, n=242). Current smokers were defined as individuals who had smoked ≥100 cigarettes in their lifetime and continued smoking. In contrast, non-smokers included individuals who had smoked fewer than 100 cigarettes in their lifetime and were not currently smoking. Participants were also asked about the number of cigarettes smoked per day and the duration of smoking in years, and pack-years were calculated accordingly. Plaque index, gingival index, probing depth, bleeding on probing, gingival recession, and attachment loss were evaluated for both groups. Periodontal health status (Periodontal health, gingivitis, and periodontitis) was assessed by one clinician applying the 2017 World Workshop on Classifying Periodontal and Peri-Implant Diseases and Conditions and the 2023 European Federation of Periodontology's Guidelines. Patients with periodontitis were classified according to stage and grade. This measurement was obtained via a calibrated UNC-15 periodontal probe at each tooth.
Read the detailed description
484 patients were asked whether they currently smoked and had smoked 100 or more cigarettes during their lifetime. Based on this information, they were divided into two groups: current smokers (test group, n=242) and non-smokers (control group, n=242). Current smokers were defined as individuals who had smoked ≥100 cigarettes in their lifetime and continued smoking. In contrast, non-smokers included individuals who had smoked fewer than 100 cigarettes in their lifetime and were not currently smoking. Participants were also asked about the number of cigarettes smoked per day and the duration of smoking in years, and pack-years were calculated accordingly. Plaque index, gingival index, probing depth, bleeding on probing, gingival recession, and attachment loss were evaluated for both groups. Periodontal health status (Periodontal health, gingivitis, and periodontitis) was assessed by one clinician applying the 2017 World Workshop on Classifying Periodontal and Peri-Implant Diseases and Conditions and the 2023 European Federation of Periodontology's Guidelines. Patients with periodontitis were classified according to stage and grade. This measurement was obtained via a calibrated UNC-15 periodontal probe at each tooth.
- Conditions
- Periodontal Diseases
- Being tested
- Intervention
- Keywords
- periodontal diseases, periodontitis, smoking, gingivitis, tabocco products
- Medical subject headings
- Periodontal Diseases, Periodontitis, Smoking, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionOther
Also called Smoking
The patient's daily cigarette consumption, duration of smoking, and pack-years were evaluated.
| Study group | Role | What they receive |
|---|---|---|
| Smoker | Current smokers were defined as individuals who had smoked ≥100 cigarettes in their lifetime and continued smoking. Receives: Other: Intervention | |
| Non-smoker | Non-smokers included individuals who had smoked fewer than 100 cigarettes in their lifetime and were not currently smoking. Receives: Other: Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
periodontal pocket depth
Periodontal pocket depth measured in millimeters using a Williams periodontal probe. The distance from the gingival margin to the bottom of the periodontal pocket was recorded at each site.
Measured: Baseline
Secondary outcomes (7)
bleeding on probing
Bleeding on probing assessed using a periodontal probe. After gently inserting the probe into the gingival sulcus and moving it laterally along the pocket wall, bleeding was recorded as present (+) or absent (-).pocket and gently moved laterally along the pocket wall. + is maximum and - is minimum.
Measured: Baseline
plaque index
Oral hygiene status assessed using the Plaque Index, which measures dental plaque accumulation adjacent to the gingival margin. Scores range from 0 (no plaque) to 3 (abundant plaque), with higher scores indicating poorer oral hygiene.
Measured: Baseline
gingival index
Gingival inflammation assessed using the Löe and Silness Gingival Index. Each site was scored on a 0-3 scale, where 0 = normal gingiva and 3 = severe inflammation with edema, redness, and spontaneous bleeding. Higher scores indicate worsening gingival inflammation.
Measured: Baseline
clinical attachment level
Clinical attachment level measured in millimeters using a periodontal probe. CAL was calculated as the distance from the cementoenamel junction to the bottom of the periodontal pocket and used to assess periodontal tissue support loss.
Measured: Baseline
Daily cigarette
It includes the number of cigarettes smoked per day. Self-reported number of cigarettes smoked per day.
Measured: Baseline
Smoking Duration
Self-reported duration of smoking, recorded as the number of years the participant has smoked.
Measured: Baseline
Pack-years
Smoking exposure calculated as pack-years, defined as the number of cigarettes smoked per day divided by 20 and multiplied by the number of years of smoking.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start2 Jan 2025
- Primary completion15 Sep 2025
- Study completion2 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 484 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tuğba ŞAHİN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tuğba ŞAHİN, Abant Izzet Baysal University
- Investigators
- TUGBA SAHIN, Principal investigator, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07295756
- Sponsor's protocol ID
- BAIBU-DH-TS-05
- Acronym
- TRSPS
- Status last verified
- Dec 2025
- First submitted
- 18 Nov 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Smoking Habits in Periodontal Health and Disease: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07295756
- Acronym / sponsor ID
- TRSPS / BAIBU-DH-TS-05
- Conditions
- Periodontal Diseases
- Keywords
- periodontal diseases, periodontitis, smoking, gingivitis, tabocco products
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 484 participants (actual)
- Lead sponsor
- Tuğba ŞAHİNUniversity, hospital or other
- Study start
- 2 Jan 2025 (actual)
- Primary completion
- 15 Sep 2025 (actual)
- Study completion
- 2 Oct 2025 (actual)
- First posted
- 22 Dec 2025 (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.
484 patients were asked whether they currently smoked and whether they had smoked 100 or more cigarettes during their lifetime. Based on this information, they were divided into two groups: current smokers (test group, n=242) and non-smokers (control group, n=242). Current smokers were defined as individuals who had smoked ≥100 cigarettes in their lifetime and continued smoking. In contrast, non-smokers included individuals who had smoked fewer than 100 cigarettes in their lifetime and were not currently smoking. Participants were also asked about the number of cigarettes smoked per day and the duration of smoking in years, and pack-years were calculated accordingly. Plaque index, gingival index, probing depth, bleeding on probing, gingival recession, and attachment loss were evaluated for both groups. Periodontal health status (Periodontal health, gingivitis, and periodontitis) was assessed by one clinician applying the 2017 World Workshop on Classifying Periodontal and Peri-Implant Diseases and Conditions and the 2023 European Federation of Periodontology's Guidelines. Patients with periodontitis were classified according to stage and grade. This measurement was obtained via a calibrated UNC-15 periodontal probe at each tooth.
Detailed description
484 patients were asked whether they currently smoked and had smoked 100 or more cigarettes during their lifetime. Based on this information, they were divided into two groups: current smokers (test group, n=242) and non-smokers (control group, n=242). Current smokers were defined as individuals who had smoked ≥100 cigarettes in their lifetime and continued smoking. In contrast, non-smokers included individuals who had smoked fewer than 100 cigarettes in their lifetime and were not currently smoking. Participants were also asked about the number of cigarettes smoked per day and the duration of smoking in years, and pack-years were calculated accordingly. Plaque index, gingival index, probing depth, bleeding on probing, gingival recession, and attachment loss were evaluated for both groups. Periodontal health status (Periodontal health, gingivitis, and periodontitis) was assessed by one clinician applying the 2017 World Workshop on Classifying Periodontal and Peri-Implant Diseases and Conditions and the 2023 European Federation of Periodontology's Guidelines. Patients with periodontitis were classified according to stage and grade. This measurement was obtained via a calibrated UNC-15 periodontal probe at each tooth.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smoker | – | Other: InterventionCurrent smokers were defined as individuals who had smoked ≥100 cigarettes in their lifetime and continued smoking. |
| Non-smoker | – | Other: InterventionNon-smokers included individuals who had smoked fewer than 100 cigarettes in their lifetime and were not currently smoking. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study includes patients who are smokers and those who are non-smokers.
Key inclusion criteria (4 listed)
- Age 18 years or older
- No systemic diseases that could affect periodontal or general health
- No history of periodontal treatment within the past six months
- For the non-smoker group: abstinence from smoking for at least five years
Key exclusion criteria (5 listed)
- Use of antibiotics or anti-inflammatory drugs
- Pregnant or lactating women
- Diabetes mellitus
- Use of waterpipe or chewing tobacco (for the smoker group)
- Individuals undergoing chemotherapy or radiotherapy
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 |
|---|---|---|
| InterventionAlso: SmokingThe patient's daily cigarette consumption, duration of smoking, and pack-years were evaluated. | Other | Non-smoker, Smoker |
Primary outcome
periodontal pocket depth
Time frame: Baseline
Periodontal pocket depth measured in millimeters using a Williams periodontal probe. The distance from the gingival margin to the bottom of the periodontal pocket was recorded at each site.
7 secondary outcomes
bleeding on probing
Time frame: Baseline
plaque index
Time frame: Baseline
gingival index
Time frame: Baseline
clinical attachment level
Time frame: Baseline
Daily cigarette
Time frame: Baseline
Smoking Duration
Time frame: Baseline
Pack-years
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 22 Dec 2025.
- Individual participant dataSharing planned: Undecided
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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.
TUGBA SAHIN principal investigator
Abant Izzet Baysal University
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 Diseases, run by Tuğba ŞAHİN 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 4 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 22 Dec 2025. 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 pocket depth (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 22 Dec 2025.