Dental CariesNCT06314100
The Effect of Aerosol Formed From Tobacco Heating Systems on the Microbiome of Supragingival Dental Biofilm
An observational study of Dental Caries, run by University of Rijeka at 1 site in Croatia.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Tobacco heating systems, cigarette smoking and non smoking
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Oct 2021to 25 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Aerosol Formed From Tobacco Heating Systems and Cigarette Smoking 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.
Read the 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 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.
- Conditions
- Dental Caries
- Being tested
- Tobacco heating systems, cigarette smoking, non smoking
- Keywords
- dental caries, dental plaque, microbiota, smoking, smoking devices
- Medical subject headings
- Dental Caries, Dental Plaque, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tobacco heating systemsDevice
Also called IQOS
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
cigarette smokingBehavioural
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 smokingBehavioural
The non smoking group of subjects serve as control for the other two groups
| Study group | Role | What they receive |
|---|---|---|
| THS smokers | Each subject undergoes a routine intraoral examination and anamnesis. Samples of supragingival dental biofilm and saliva are taken for microbiological analysis Receives: 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 Receives: 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 Receives: Behavioral: non smoking |
What is being measured
The primary outcome is the main question the study is designed to answer.
diversity of bacterial species
The number of different bacterial species present in the supragingival dental biofilm
Measured: baseline
abundance of bacterial species
The quantity of each different bacterial species present in the supragingival dental biofilm
Measured: 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(%))
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start1 Oct 2021
- Primary completion25 Oct 2023
- Study completion25 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rijeka
- Sponsor type
- University, hospital or other
- Collaborators
- Croatian Science Foundation
- Responsible party
- Principal investigator, Elvis Bozac, University of Rijeka
- Investigators
- Elvis Božac, DMD, Principal investigator, Faculty of dental medicine, University of Rijeka
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06314100
- Sponsor's protocol ID
- IP-2020-02-4027-EB
- Status last verified
- Mar 2024
- First submitted
- 3 Mar 2024
- Last updated
- 15 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 38888700
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Aerosol Formed From Tobacco Heating Systems and Cigarette Smoking on the Microbiome of Supragingival Dental Biofilm
- ClinicalTrials.gov ID
- NCT06314100
- Acronym / sponsor ID
- IP-2020-02-4027-EB
- Conditions
- Dental Caries
- Keywords
- dental caries, dental plaque, microbiota, smoking, smoking devices
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of RijekaUniversity, hospital or other
- Collaborators
- Croatian Science Foundation
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 25 Oct 2023 (actual)
- Study completion
- 25 Oct 2023 (actual)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| THS smokers | – | Device: Tobacco heating systemsEach subject undergoes a routine intraoral examination and anamnesis. Samples of supragingival dental biofilm and saliva are taken for microbiological analysis |
| cigarette smokers | – | Behavioral: cigarette smokingEach subject undergoes a routine intraoral examination and anamnesis. Samples of supragingival dental biofilm and saliva are taken for microbiological analysis |
| nonsmokers | – | Behavioral: non smokingEach subject undergoes a routine intraoral examination and anamnesis. Samples of supragingival dental biofilm and saliva are taken for microbiological analysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tobacco heating systemsAlso: IQOSThe 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 | Device | THS smokers |
| cigarette smokingThe study aims to explore the effect of cigarette smoking on microbiome of the supragingival dental biofilm and the risk of developing caries lesions | Behavioural | cigarette smokers |
| non smokingThe non smoking group of subjects serve as control for the other two groups | Behavioural | nonsmokers |
Primary outcome
diversity of bacterial species
Time frame: baseline
The number of different bacterial species present in the supragingival dental biofilm
abundance of bacterial species
Time frame: baseline
The quantity of each different bacterial species present in the supragingival dental biofilm
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(%))
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Derived from this study: PubMed 38888700Bozac 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elvis Božac, DMD principal investigator
Faculty of dental medicine, University of Rijeka
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Caries, run by University of Rijeka at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diversity of bacterial species (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06314100, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.