NCT07521644

Dysbiosis of Methanogenic Archaea and Nanoarchaea in the Oral Microbiome

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Assistance Publique Hopitaux De Marseille · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Need to improve understanding of oral dysbiosis in the elderly and/or immunocompromised individuals (involvement of nanogenes in these dysbiosis) Comparison of dysbiosis identification between results from dental plaque samples and saliva samples (the saliva sample is non-operator-dependent due to its ease of collection). Comparison of the reliability of results obtained with this type of saliva sample versus results obtained with dental plaque samples, which are considered the reference sample type (Antézack 2023). Primary objective To estimate the prevalence of dysbiosis in individuals with oral frailty versus individuals without oral frailty. In this project: * Dysbiosis will be defined by the presence of Archaea (Bringuier 2013). For the primary objective, prevalence will be estimated based on dental plaque samples. * The population with oral frailty will be defined as individuals over 60 years of age or those with immunosuppression. Hypothesis: The expected proportion of dysbiosis in the population with oral health vulnerability is 40%, whereas the expected proportion of dysbiosis in the population without oral health vulnerability is 20% (Li CL 2009). Secondary objectives Estimate the prevalence of dysbiosis in the two populations based on a saliva sample \- Compare the results from the sample

Detailed description

Study Design A cross-sectional case-control study. Participation in the study will be offered to all eligible subjects who meet the inclusion criteria. Number of Patients 250 patients. For each patient, a dental plaque sample and a saliva sample will be collected during the visit.

Conditions

• Oral Health

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Dental plaque sample	Dental plaque sample
DIAGNOSTIC_TEST	Saliva sample	Saliva sample using a swab

Timeline

• Start date: 2026-09-01
• Primary completion: 2029-09-01
• Completion: 2029-12-01
• First posted: 2026-04-13
• Last updated: 2026-04-13

Locations

1 site across 1 country: France