Involvement of Archaea in Carious Disease

NCT06787261 | Recruiting

• 1 other identifier: RCAPHM24-0329
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries

Keywords

Dental caries

Outcome Measures

Primary Outcomes (1)

• Presence/absence of Archaea in participants' saliva samples.

  36 months

Secondary Outcomes (2)

• Quantity of Archaea in the salivary sample of the participants.

  36 months

• Viability/non-viability of Archaea in carious lesions

  36 months

Study Arms (2)

low risk of carriages

EXPERIMENTAL

Other: saliva sample

high risk for caries.

OTHER

Other: saliva sample; Other: carious tissue samples

Interventions

saliva sample OTHER

saliva sample

high risk for caries.; low risk of carriages

carious tissue samples OTHER

carious tissue samples

high risk for caries.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Asssistance Publique Hopitaux de Marseille

Marseille, 13354, France

RECRUITING

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• jean-olivier ARNAUD GENERAL DIRECTOR

  Assistance Publique Hopitaux De Marseille

  STUDY DIRECTOR

Central Study Contacts

Giuliani alexandra project manager

CONTACT

+33491382747; alexandra.giuliani@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: January 22, 2025
• Study Start: February 19, 2026
• Primary Completion (Estimated): February 19, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: February 23, 2026

Record last verified: 2026-02

Locations

FR (1)