The Effect of Aerosol Formed From Tobacco Heating Systems on the Microbiome of Supragingival Dental Biofilm

NCT06314100 | Completed FDA Device

• 1 other identifier: IP-2020-02-4027-EB
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Dental caries is a multifactorial disease primarily caused by supragingival dental biofilm. Its progression is influenced by many environmental factors, which include smoking. Tobacco heating systems (THS) are a novel tobacco product whose effect on the microbiome of the supragingival dental biofilm has not yet been investigated. The aim of the proposed research is to determine and compare the composition of the microbiomes of the supragingival dental biofilm of THS smokers, cigarette smokers, and nonsmokers using the Next Generation Sequencing method and to assess and compare the risk of new caries lesion formation between the test groups using the Cariogram method. The results of this research will provide insight into changes in the microbiome of the supragingival dental biofilm resulting from exposure to aerosols from tobacco combustion and tobacco heating.

Conditions

Dental Caries

Keywords

dental caries; dental plaque; microbiota; smoking; smoking devices

Outcome Measures

Primary Outcomes (3)

• diversity of bacterial species

  The number of different bacterial species present in the supragingival dental biofilm

  baseline

• abundance of bacterial species

  The quantity of each different bacterial species present in the supragingival dental biofilm

  baseline

• caries risk

  The risk of avoiding/developing new caries lesions calculated through the Cariogram computer application (the results are represented as chances which are expressed in percetagens(%))

  baseline

Study Arms (3)

THS smokers

Each subject undergoes a routine intraoral examination and anamnesis. Samples of supragingival dental biofilm and saliva are taken for microbiological analysis

Device: Tobacco heating systems

cigarette smokers

Each subject undergoes a routine intraoral examination and anamnesis. Samples of supragingival dental biofilm and saliva are taken for microbiological analysis

Behavioral: cigarette smoking

nonsmokers

Each subject undergoes a routine intraoral examination and anamnesis. Samples of supragingival dental biofilm and saliva are taken for microbiological analysis

Behavioral: non smoking

Interventions

Tobacco heating systems DEVICE

The study aims to explore the effect of tobacco heating system consumption on microbiome of the supragingival dental biofilm and the risk of developing caries lesions

Also known as: IQOS

THS smokers

cigarette smoking BEHAVIORAL

The study aims to explore the effect of cigarette smoking on microbiome of the supragingival dental biofilm and the risk of developing caries lesions

cigarette smokers

non smoking BEHAVIORAL

The non smoking group of subjects serve as control for the other two groups

nonsmokers

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

In the present study a total of 60 subject are enrolled. The subjects are divided into 3 groups: tobacco heating system smokers, cigarette smokers and non-smokers. In each group there are 20 subjects which are age and gender matched.

You may qualify if:

• smokers of tobacco heating systems that have smoked at least 100 heating sticks during their lifetime and have smoked exclusively tobacco heating systems for at least 6 months
• cigarette smokers that have smoked at least 100 cigarettes during their lifetime and have smoked exclusively factory made cigarettes for at least 6 months
• non-smokers that have never smoked during their lifetime
• signed informed consent

You may not qualify if:

• use of antibiotics 3 month prior to examination and sampling
• active orthodontic treatment
• patients suffering from autoimmune diseases
• patients suffering from type II diabetes
• constant use of oral antiseptics
• use of corticosteroids of other immunosuppressive drugs/treatments
• patients who have less than 10 teeth

Sponsors & Collaborators

• University of Rijeka: lead
• Croatian Science Foundation: collaborator

Study Sites (1)

Faculty of dental medicine, University of Rijeka

Rijeka, Croatia

Location

Related Publications (1)

• Bozac E, Paljevic E, Sever E, Braut A, Spalj S, Persic Bukmir R. Clinical characteristics and caries risk assessment of tobacco heating systems smokers, cigarette smokers and non-smokers: a cross-sectional study. Clin Oral Investig. 2024 Jun 18;28(7):382. doi: 10.1007/s00784-024-05778-0.

  PMID: 38888700 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Supragingival dental biofilm samples for bacterial DNA isolation and sequencing

MeSH Terms

Conditions

Dental Caries; Dental Plaque; Smoking

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Dental Deposits; Behavior

Study Officials

• Elvis Božac, DMD

  Faculty of dental medicine, University of Rijeka

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching assistant (Department of Endodontics and Restorative dentistry), DMD

Study Record Dates

• First Submitted: March 3, 2024
• First Posted: March 15, 2024
• Study Start: October 1, 2021
• Primary Completion: October 25, 2023
• Study Completion: October 25, 2023
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)