Investigating the Periodontal Status of Traditional and Heated Tobacco Product Users

NCT06784817 | Recruiting

• 1 other identifier: SE RKEB 131/2023
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gingivitis and Periodontal Diseases

Keywords

smoking; heated tobacco products; periodontal diseases

Outcome Measures

Primary Outcomes (1)

• Marginal bone loss in mm ( MBL)

  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 Outcomes (5)

• Full mouth plaque index (PI)

  At baseline (first visit)

• Bleeding on Probing (BOP)

  At baseline (first visit)

• Probing Pocket Depth (PPD)

  At baseline (first visit)

• Clinical attachment level (CAL)

  At baseline (first visit)

• Gingival Crevicular Fluid (GCF) volume in μL

  At baseline (first visit)

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Semmelweis University: lead
• Center for Translational Medicine: collaborator

Study Sites (1)

Semmelweis University Department of Prosthodontics

Budapest, Pest County, 1088, Hungary

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Gingival crevicular fluid samples will be collected from the deepest periodontal pocket on the buccal aspects of the mesial or distal interproximal sites of a maxillary single rooted tooth. 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. 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 (μL).

MeSH Terms

Conditions

Gingivitis; Periodontal Diseases; Smoking

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Mouth Diseases; Stomatognathic Diseases; Behavior

Study Officials

• Barbara Kispélyi, Dental

  Semmelweis University, Department of Prosthodontics

  STUDY DIRECTOR

• Kata Kelemen, Dental

  Semmelweis University, Department of Prosthodontics

  STUDY DIRECTOR

• Brigitta Teutsch, Medical doctor

  Center for Translational Medicine, Semmelweis University

  STUDY CHAIR

Central Study Contacts

Orsolya Vámos, Dental

CONTACT

+3614591500/59313; vamos.orsolya@semmelweis.hu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 20, 2025
• Study Start: September 1, 2023
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: January 20, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)