NCT07295756

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
484

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2025

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 22, 2025

Completed
Last Updated

December 22, 2025

Status Verified

December 1, 2025

Enrollment Period

9 months

First QC Date

November 18, 2025

Last Update Submit

December 8, 2025

Conditions

Keywords

periodontal diseasesperiodontitissmokinggingivitistabocco products

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline

Secondary Outcomes (7)

  • bleeding on probing

    Baseline

  • plaque index

    Baseline

  • gingival index

    Baseline

  • clinical attachment level

    Baseline

  • Daily cigarette

    Baseline

  • +2 more secondary outcomes

Study Arms (2)

Smoker

Current smokers were defined as individuals who had smoked ≥100 cigarettes in their lifetime and continued smoking.

Other: Intervention

Non-smoker

Non-smokers included individuals who had smoked fewer than 100 cigarettes in their lifetime and were not currently smoking.

Other: Intervention

Interventions

The patient's daily cigarette consumption, duration of smoking, and pack-years were evaluated.

Also known as: Smoking
Non-smokerSmoker

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study includes patients who are smokers and those who are non-smokers.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bolu Abant Izzet Baysal University, Dentistry Faculty

Bolu, 14030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontal DiseasesPeriodontitisSmokingGingivitis

Interventions

MethodsSmoking Devices

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesBehaviorInfectionsGingival Diseases

Intervention Hierarchy (Ancestors)

Investigative TechniquesManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • TUGBA SAHIN

    Abant Izzet Baysal University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

November 18, 2025

First Posted

December 22, 2025

Study Start

January 2, 2025

Primary Completion

September 15, 2025

Study Completion

October 2, 2025

Last Updated

December 22, 2025

Record last verified: 2025-12

Locations