Archaea and tooth decay
Involvement of Archaea in Carious Disease
NA · Assistance Publique Hopitaux De Marseille · NCT06787261
This project tests whether certain archaea in saliva and cavity tissue are linked to tooth decay in adults treated at the Timone dentistry clinic.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique Hopitaux De Marseille (other) |
| Locations | 1 site (Marseille) |
| Trial ID | NCT06787261 on ClinicalTrials.gov |
What this trial studies
The team will collect saliva and carious tissue samples from adult patients at the PROMOD - Timone Restorative and Preventive Dentistry unit and screen them for methanogenic archaea. Samples will be analyzed by culture and molecular methods using the group's dedicated archaea platform to identify and quantify archaeal species. Researchers will compare archaeal presence and load against each patient's individual caries risk profile to look for associations. The investigators bring prior experience culturing methanogens and have previously discovered human nanoarchaea, providing specialized laboratory capability for this work.
Who should consider this trial
Good fit: Adult patients under care at the PROMOD - Timone Restorative and Preventive Dentistry unit who can give written consent, are covered by social security, and have not used antibiotics in the past month or mouthwash in the past week are appropriate candidates.
Not a fit: Patients with periodontitis, minors, people under guardianship or deprived of liberty, pregnant or breastfeeding women, those who recently used antibiotics or mouthwash, or people who cannot read and understand French are not eligible and would not benefit from participation.
Why it matters
Potential benefit: If successful, the findings could lead to improved prevention or targeted treatments for tooth decay by identifying archaeal contributors in the mouth.
How similar studies have performed: Archaea have been associated with periodontal disease in prior work, but their direct role in carious lesions has been little studied, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Marseille
- Asssistance Publique Hopitaux de Marseille — Marseille, France (RECRUITING)
Study contacts
- Study coordinator: Giuliani alexandra project manager
- Email: alexandra.giuliani@ap-hm.fr
- Phone: +33491382747
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Dental Caries, Dental caries