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Recruiting NCT06787261

Involvement of Archaea in Carious Disease

No phase Interventional Dental Caries

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: saliva sample, carious tissue samples.
Who it may be relevant to
Registry conditions: Dental Caries. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Other saliva sample
    saliva sample
  • Other carious tissue samples
    carious tissue samples

Primary outcome measures

  • Presence/absence of Archaea in participants' saliva samples. [Time frame: 36 months]
Secondary outcome measures (2)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

France · 1 center
  • Asssistance Publique Hopitaux de Marseille — Marseille

Identifiers

NCT: NCT06787261 · RCAPHM24-0329

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗