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

Dental Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06314100
• Other study ID #: IP-2020-02-4027-EB
• Status: Completed
• Start date: October 1, 2021
• Est. completion date: October 25, 2023

Study information

• Verified date: March 2024
• Source: University of Rijeka
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 25, 2023
• Est. primary completion date: October 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries

Intervention

Device:
• Tobacco heating systems
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

Behavioral:
• cigarette smoking
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
The non smoking group of subjects serve as control for the other two groups

Locations

Country	Name	City	State
Croatia	Faculty of dental medicine, University of Rijeka	Rijeka

Sponsors (2)

Lead Sponsor	Collaborator
University of Rijeka	Croatian Science Foundation

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diversity of bacterial species	The number of different bacterial species present in the supragingival dental biofilm	baseline
Primary	abundance of bacterial species	The quantity of each different bacterial species present in the supragingival dental biofilm	baseline
Primary	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