Investigating the Periodontal Status of Traditional and Heated Tobacco Product Users

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSemmelweis University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial population

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

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

90 Participants
are grouped into 3 trial groups
Group A: Non-smokers
Group B: Cigarette smokers
Group C: Heated tobacco product users

Trial outcomes

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

Time frame
At baseline (first visit)

Secondary outcomes

1

Full mouth plaque index (PI)

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

Time frame
At baseline (first visit)
2

Bleeding on Probing (BOP)

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

Time frame
At baseline (first visit)
3

Probing Pocket Depth (PPD)

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

Time frame
At baseline (first visit)
4

Clinical attachment level (CAL)

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

Time frame
At baseline (first visit)

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Semmelweis University Department of ProsthodonticsRecruiting1088, Budapest, Pest CountyHungaryHungary

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Semmelweis University

Lead sponsor

Center for Translational Medicine

Collaborator