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Involvement of Archaea in Carious Disease (CARIARCHAE)

P

Public Assistance-Hospitals of Marseille (AP-HM)

Status

Not yet enrolling

Conditions

Dental Caries

Treatments

Other: saliva sample
Other: carious tissue samples

Study type

Interventional

Funder types

Other

Identifiers

NCT06787261
RCAPHM24-0329

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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.

Exclusion criteria

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 design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

200 participants in 2 patient groups

low risk of carriages
Experimental group
Treatment:
Other: saliva sample
high risk for caries.
Other group
Treatment:
Other: carious tissue samples
Other: saliva sample

Trial contacts and locations

1

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Central trial contact

Giuliani alexandra project manager

Data sourced from clinicaltrials.gov

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