Investigating the Periodontal Status of Traditional and Heated Tobacco Product Users (INPER-THT)

January 15, 2025 updated by: Semmelweis University

Investigating the Periodontal Status of Traditional and Heated Tobacco Product Users: A Cross-sectional Observational Study

This cross-sectional observational study aims to compare the clinical and radiographic periodontal status, as well as gingival crevicular fluid volume, among cigarette smokers, heated-tobacco product users, and non-smokers. Specifically, the aim is to determine whether tobacco product users exhibit worse clinical parameters-such as probing pocket depth, bleeding on probing, plaque index, clinical attachment loss-along with greater radiographic bone loss and higher gingival crevicular fluid volume than non-smokers.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Smoking is one of the main risk factors of periodontitis and its harmful effects on periodontal health are now well known. Thanks to worldwide restrictions, the use of traditional cigarettes is declining, but new alternative tobacco products such as heated tobacco products (e.g. IQOS, glo) have appeared on the market. These devices are often perceived less harmful by consumers, but there are conflicting results in the literature regarding their health effects.

Only one study has assessed periodontal health in heated tobacco product users, but in this study all participants were former smokers. No studies have evaluated periodontal health in heated tobacco users without a history of smoking traditional cigarettes on a regular basis.

Therefore, the aim of the present cross-sectional observational study is to compare the clinical and radiographic periodontal status and gingival crevicular fluid (GCF) volume among cigarette-smokers, heated-tobacco product users and non-smokers.

The null hypothesis is that different tobacco product users have worse clinical and radiological periodontal parameters and higher GCF volume than non-smokers.

The study will be performed at the Department of Prosthodontics at Semmelweis University, Budapest, Hungary. Patients will be enrolled from the patient material of the Department of Prosthodontics.

Study Type

Observational

Enrollment (Estimated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hungary
    • Pest
      • Budapest, Pest, Hungary, 1088
        • Recruiting
        • Semmelweis University Department of Prosthodontics
        • Contact:
        • Contact:
        • Principal Investigator:
          • Orsolya Vámos, Dental

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

Healthy induviduals with no systemic diseases will be selected for this study.

Description

Inclusion Criteria:

  • Smokers who smoke at least one cigarette daily for the past 12 months.
  • Exclusive users of heated tobacco products (e.g., IQOS), using them at least once daily for the past 12 months and not regular traditional cigarette smokers.
  • Non-smokers who have never consumed tobacco in any form.

Exclusion Criteria:

  • Users of electronic cigarettes, smokeless tobacco, waterpipes, or any other tobacco products.
  • Dual users of tobacco products.
  • Individuals diagnosed with systemic diseases.
  • Edentulousness or severe tooth loss (fewer than 20 remaining teeth).
  • Individuals who have taken antibiotics, steroids, or non-steroidal anti-inflammatory drugs in the past 90 days.
  • Pregnant or breastfeeding women.
  • History of periodontitis.
  • Individuals refusing to sign the written informed consent form.
  • Third molars are excluded from examination.

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
Non-smokers
Never consumed tobacco in any form
Cigarette smokers
Smoking at least 1 cigarette daily for at least 12 months
Heated tobacco product users
Using heated tobacco products e.g. IQOS exclusively at least once daily in the past 12 months and was not a regular traditional cigarette smoker

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Marginal bone loss in mm ( MBL)
Time Frame: At baseline (first visit)

Digital periapical radiographs will be taken of each tooth and be viewed on a calibrated computer screen using a software program. MBL is defined as the vertical distance from 2 mm below the cemento-enamel junction (CEJ) to the most crestal part of marginal alveolar bone.

Measures of effect: mean and standard deviation
At baseline (first visit)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Full mouth plaque index (PI)
Time Frame: At baseline (first visit)

It is measured at 6 sites per tooth (mesio-buccal, mid-buccal, disto-buccal,disto-lingual/palatal, mid-lingual/palatal and mesio-lingual/palatal) on all maxillary and mandibular teeth, except third molars. It is measured dichotomously. Score 1 if plaque biofilm is present and 0 if plaque biofilm is absent. A percentage score for the whole mouth is obtained by adding together the values for all teeth, dividing by the number of teeth and multiplying the result by 100.

Measures of effect: mean and standard deviation
At baseline (first visit)
Bleeding on Probing (BOP)
Time Frame: At baseline (first visit)

It is measured at 6 sites per tooth (mesio-buccal, mid-buccal, disto-buccal,disto-lingual/palatal, mid-lingual/palatal and mesio-lingual/palatal) on all maxillary and mandibular teeth, except third molars. It is measured dichotomously. Score 1 if bleeding is present and 0 if bleeding is absent. A percentage score for the whole mouth is obtained by adding together the values for all teeth, dividing by the number of teeth and multiplying the result by 100.

Measures of effect: mean and standard deviation
At baseline (first visit)
Probing Pocket Depth (PPD)
Time Frame: At baseline (first visit)
It is measured at 6 sites per tooth (mesio-buccal, mid-buccal, disto-buccal,disto-lingual/palatal, mid-lingual/palatal and mesio-lingual/palatal) on all maxillary and mandibular teeth, except third molars. Using an UNC-15 periodontal probe, the distance from the gingival margin to the base of the periodontal pocket or sulcus is measured. This is recorded in millimeters (mm). Measures of effect: mean and standard deviation
At baseline (first visit)
Clinical attachment level (CAL)
Time Frame: At baseline (first visit)
It is measured at 6 sites per tooth (mesio-buccal, mid-buccal, disto-buccal,disto-lingual/palatal, mid-lingual/palatal and mesio-lingual/palatal) on all maxillary and mandibular teeth, except third molars. To calculate the CAL, the position of the gingival margin relative to the cementoenamel junction (CEJ) and the probing pocket depth is added together. CAL ismeasured in millimeter to the nearest mm using UNC-15 periodontal probe. Measures of effect: mean and standard deviation
At baseline (first visit)
Gingival Crevicular Fluid (GCF) volume in μL
Time Frame: At baseline (first visit)

GCF samples are taken from the deepest periodontal pocket on the buccal aspects of the mesial or distal interproximal sites of a maxillary single rooted tooth. Prior to GCF collection, the selected site is isolated with sterile cotton swabs and the supragingival oral biofilm is carefully removed. The tooth is then dried with a gentle air. A sterile paper strip (Periopaper, Amityville, NY, USA) is placed in the periodontal sulcus until resistance is felt and then held in place for 30 seconds. Samples contaminated with blood or saliva are discarded and a new sample is taken from the same site after 15 minutes. The strips of paper are then immediately placed in a calibrated electronic gingival fluid measuring device (Periotron 8000, Oraflow. Inc., New York) for volume determination.

Measures of effect: mean and standard deviation
At baseline (first visit)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Semmelweis University

Collaborators

Center for Translational Medicine

Investigators

  • Study Director: Barbara Kispélyi, Dental, Semmelweis University, Department of Prosthodontics
  • Study Director: Kata Kelemen, Dental, Semmelweis University, Department of Prosthodontics
  • Study Chair: Brigitta Teutsch, Medical doctor, Center for Translational Medicine, Semmelweis 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)

September 1, 2023

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

January 9, 2025

First Submitted That Met QC Criteria

January 15, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 15, 2025

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SE RKEB 131/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

All data supporting our findings will be found in the prepared manuscript and the supplementary material.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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