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 volunteersQualifiers
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
Case-control
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
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
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
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
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
Locations
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Sponsors and contacts
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Semmelweis University
Lead sponsor
Center for Translational Medicine
Collaborator