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Completed

NCT Number: NCT06314100

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of dental medicine, University of Rijeka

Rijeka, Croatia

About this study

Dental caries is a dynamic disease caused by the presence of dental biofilm which leads to the demineralization and loss of hard dental tissues. Historically, the main microbes which were considered responsible for developing caries lesions were Streptococcus mutans and Lactobacilli, but results of recent studies have shown tha a far greater number of microorganisms and microbial interactions are present. Furthermore the progress of the disease is also affected by many environmental factors like tobacco smoking.

A wide number of studies have already confirmed a positive correlation between tobacco smoking and the incidence/presence of caries lesions in different populations of all ages. Also, invitro studies have confirmed that bacterial proliferation and metabolic activity is affected by the components, and concentrations of components of cigarette smoke, especially nicotine.

Tobacco heating systems (THS) are a relatively novel nicotine delivery product that when consumed creates an aerosol that has the same contents as cigarette smoke, but the concentration of it's components is greatly reduced. The effect of THS smoking on the bacterial microbiome of supragingival dental biofilm has not yet been researched.

In the present study a total of 60 subject have been enrolled: 20 THS smokers, 20 cigarette smokers and 20 non-smokers. Subject from each group are age and gender matched.

The goal of the study is to compare the bacterial microbiomes of supragingival dental biofilm of the 3 examined groups. This will be done by collecting supragingival dental biofilm samples, isolating bacterial DNA from them and conducting 16s RNA metagenomics through next generation sequencing.

Furthermore, caries risk assessments will be conducted through the Cariogram method . Necessary data for the Cariogram analysis is obtained through routine anamnesis, intraoral clinical examination and tests.

The results of the study will give more insight into the effects of THS and cigarette smoking on the microbiome and microbial interactions in supragingival dental biofilm.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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

Other names: IQOS

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

non smoking

Behavioral

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

Primary outcomes

  1. diversity of bacterial species

    Time frame: baseline

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

  2. abundance of bacterial species

    Time frame: baseline

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

  3. caries risk

    Time frame: baseline

    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(%))

Sponsors and collaborators

Lead sponsor

University of Rijeka

Other

Collaborators

  • Croatian Science Foundation

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 15, 2024
Registry last updated
Mar 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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