Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06314100
Status:
COMPLETED
Last Update Posted:
2024-03-15
First Post:
2024-03-03
Brief Title:
The Effect of Aerosol Formed From Tobacco Heating Systems on the Microbiome of Supragingival Dental Biofilm
Sponsor:
University of Rijeka
Organization:
University of Rijeka
Study Overview
Official Title:
The Effect of Aerosol Formed From Tobacco Heating Systems and Cigarette Smoking on the Microbiome of Supragingival Dental Biofilm
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed 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 incidencepresence 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 its 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
A wide number of studies have already confirmed a positive correlation between tobacco smoking and the incidencepresence 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 its 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None