Involvement of Archaea in Carious Disease

Not Applicable

Not yet recruiting

• Conditions: Dental Caries

• Registration Number: NCT06787261
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief 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.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study Start: 2025-01-15
• Study First Submitted: 2025-01-16
• Study First Submitted QC: 2025-01-16
• Last Update Submitted: 2025-01-16
• Study First Posted: 2025-01-22
• Last Update Posted: 2025-01-22
• Primary Completion: 2028-01-15
• Study Completion: 2028-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Presence/absence of Archaea in participants' saliva samples.	36 months

Secondary Outcome Measures

Name	Time	Method
Quantity of Archaea in the salivary sample of the participants.	36 months
Viability/non-viability of Archaea in carious lesions	36 months

Trial Locations

Locations (1)

Asssistance Publique Hopitaux de Marseille; 🇫🇷 Marseille, France