Dental CariesCARIARCHAENCT06787261
Involvement of Archaea in Carious Disease
A study testing saliva sample and carious tissue samples in people with Dental Caries, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Dental caries is a major public health probleme the result of hard tissue demineralization and oral microbiota changes. Methanogenic archaea, mainly Methanobrevibacter oralis, are associated with various oral problems, including pathologies periodontal. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Caries
- What is being tested?
- saliva sample and carious tissue samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 19 Feb 2026to 1 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female of legal age.
- Patient who is a beneficiary or entitled beneficiary of a social security
- Patient under the care of the Restorative and Preventive Dentistry of the PROMOD - Timone Dentistry Unit.
- Patients capable of giving written consent.
Who cannot join
- Patient in a period of exclusion from another research protocol at the time of signing the consent form, Subjects covered by articles L1121-5 to 1121-8 of the Public Health public health code (minor patients, patients of full age under guardianship, patients deprived of their liberty, pregnant or breast-feeding), A person who does not have a sufficient command of reading and understanding of the French language to be able to consent to take part in the research Presence of periodontitis (gingivitis not being a criterion for a criterion for non-inclusion). Antibiotics taken in the previous month. Use of mouthwash in the previous 7 days.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Asssistance Publique Hopitaux de Marseille
Marseille, 13354
PILLIOL Virginie investigator, virginie.pilliol@ap-hm.fr
About this study
Dental caries is a major public health probleme the result of hard tissue demineralization and oral microbiota changes.
Methanogenic archaea, mainly Methanobrevibacter oralis, are associated with various oral problems, including pathologies periodontal.
Read more
Previous research has not really studied the Archaea in carious lesions, hence the importance of our study.
Our study aims to explore their potential role in the the development of caries by analysing their prevalence and their quantification in relation to the carious risk individual. The aim is to improve understanding of the Cavity microbiology to advance management of this pathology in terms of prevention or of treatment.
Our team is particularly competent in the field of Archaea, especially in the cultivation of Archaea methanogens since we have a dedicated platform. We also discovered the first human Nanoarchaea, opening up a whole new possible search field.
- Conditions
- Dental Caries
- Being tested
- saliva sample, carious tissue samples
- Keywords
- Dental caries
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
saliva sampleOther
saliva sample
carious tissue samplesOther
carious tissue samples
| Study group | Role | What they receive |
|---|---|---|
| low risk of carriages | Experimental | Not described Receives: Other: saliva sample |
| high risk for caries. | Other | Not described Receives: Other: saliva sample; Other: carious tissue samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence/absence of Archaea in participants' saliva samples.
Measured: 36 months
Secondary outcomes (2)
Quantity of Archaea in the salivary sample of the participants.
Measured: 36 months
Viability/non-viability of Archaea in carious lesions
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start19 Feb 2026
- Primary completion19 Feb 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- jean-olivier ARNAUD GENERAL DIRECTOR, Study director, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06787261
- Sponsor's protocol ID
- RCAPHM24-0329
- Acronym
- CARIARCHAE
- Status last verified
- Feb 2026
- First submitted
- 16 Jan 2025
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Involvement of Archaea in Carious Disease
- ClinicalTrials.gov ID
- NCT06787261
- Acronym / sponsor ID
- CARIARCHAE / RCAPHM24-0329
- Conditions
- Dental Caries
- Keywords
- Dental caries
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 19 Feb 2026 (actual)
- Primary completion
- 19 Feb 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 22 Jan 2025 (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 major public health probleme the result of hard tissue demineralization and oral microbiota changes.
Methanogenic archaea, mainly Methanobrevibacter oralis, are associated with various oral problems, including pathologies periodontal.
Previous research has not really studied the Archaea in carious lesions, hence the importance of our study.
Our study aims to explore their potential role in the the development of caries by analysing their prevalence and their quantification in relation to the carious risk individual. The aim is to improve understanding of the Cavity microbiology to advance management of this pathology in terms of prevention or of treatment.
Our team is particularly competent in the field of Archaea, especially in the cultivation of Archaea methanogens since we have a dedicated platform. We also discovered the first human Nanoarchaea, opening up a whole new possible search field.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low risk of carriages | Experimental | Other: saliva sample |
| high risk for caries. | Other | Other: saliva sample, Other: carious tissue samples |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female of legal age.
- Patient who is a beneficiary or entitled beneficiary of a social security
- Patient under the care of the Restorative and Preventive Dentistry of the PROMOD - Timone Dentistry Unit.
- Patients capable of giving written consent.
Key exclusion criteria (1 listed)
- Patient in a period of exclusion from another research protocol at the time of signing the consent form, Subjects covered by articles L1121-5 to 1121-8 of the Public Health public health code (minor patients, patients of full age under guardianship, patients deprived of their liberty, pregnant or breast-feeding), A person who does not have a sufficient command of reading and understanding of the French language to be able to consent to take part in the research Presence of periodontitis (gingivitis not being a criterion for a criterion for non-inclusion). Antibiotics taken in the previous month. Use of mouthwash in the previous 7 days.
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 |
|---|---|---|
| saliva samplesaliva sample | Other | high risk for caries., low risk of carriages |
| carious tissue samplescarious tissue samples | Other | high risk for caries. |
Primary outcome
Presence/absence of Archaea in participants' saliva samples.
Time frame: 36 months
2 secondary outcomes
Quantity of Archaea in the salivary sample of the participants.
Time frame: 36 months
Viability/non-viability of Archaea in carious lesions
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
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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.
jean-olivier ARNAUD GENERAL DIRECTOR study director
Assistance Publique Hopitaux De Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing saliva sample and carious tissue samples in people with Dental Caries, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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 1 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: looking for participants now, as of the sponsor's last update on 23 Feb 2026. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giuliani alexandra project manager (+33491382747, alexandra.giuliani@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence/absence of Archaea in participants' saliva samples. (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Feb 2026.