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NCT Number: NCT06787261

Involvement of Archaea in Carious Disease

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asssistance Publique Hopitaux de Marseille

Marseille, 13354, France

Location status: Recruiting

Location contact

PILLIOL Virginie investigator

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Saliva Sample

Other

saliva sample

carious tissue samples

Other

carious tissue samples

Primary outcomes

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

    Time frame: 36 months

Secondary outcomes

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

    Time frame: 36 months

  2. Viability/non-viability of Archaea in carious lesions

    Time frame: 36 months

Study contacts

Contact information is provided by the study sponsor or research team.

Giuliani alexandra project manager

CONTACT

[email protected]

+33491382747

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Acronym: CARIARCHAE

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jan 22, 2025
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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