- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07295756
The Role of Smoking in Periodontal Status (TRSPS)
December 8, 2025 updated by: Tuğba ŞAHİN
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.
Study Overview
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 Type
Observational
Enrollment (Actual)
484
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bolu, Turkey (Türkiye), 14030
- Bolu Abant Izzet Baysal University, Dentistry Faculty
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
The study includes patients who are smokers and those who are non-smokers.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Smoker
Current smokers were defined as individuals who had smoked ≥100 cigarettes in their lifetime and continued smoking.
|
The patient's daily cigarette consumption, duration of smoking, and pack-years were evaluated.
Other Names:
|
|
Non-smoker
Non-smokers included individuals who had smoked fewer than 100 cigarettes in their lifetime and were not currently smoking.
|
The patient's daily cigarette consumption, duration of smoking, and pack-years were evaluated.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
bleeding on probing
Time Frame: Baseline
|
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.
|
Baseline
|
|
plaque index
Time Frame: Baseline
|
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.
|
Baseline
|
|
gingival index
Time Frame: Baseline
|
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.
|
Baseline
|
|
clinical attachment level
Time Frame: Baseline
|
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.
|
Baseline
|
|
Daily cigarette
Time Frame: Baseline
|
It includes the number of cigarettes smoked per day.
Self-reported number of cigarettes smoked per day.
|
Baseline
|
|
Smoking Duration
Time Frame: Baseline
|
Self-reported duration of smoking, recorded as the number of years the participant has smoked.
|
Baseline
|
|
Pack-years
Time Frame: Baseline
|
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.
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: TUGBA SAHIN, Abant Izzet Baysal University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 2, 2025
Primary Completion (Actual)
September 15, 2025
Study Completion (Actual)
October 2, 2025
Study Registration Dates
First Submitted
November 18, 2025
First Submitted That Met QC Criteria
December 8, 2025
First Posted (Actual)
December 22, 2025
Study Record Updates
Last Update Posted (Actual)
December 22, 2025
Last Update Submitted That Met QC Criteria
December 8, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BAIBU-DH-TS-05
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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