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NOT YET RECRUITING
NCT07521644
NA

Dysbiosis of Methanogenic Archaea and Nanoarchaea in the Oral Microbiome

Sponsor: Assistance Publique Hopitaux De Marseille

View on ClinicalTrials.gov

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

250

Start Date

2026-09-01

Completion Date

2029-12-01

Last Updated

2026-04-13

Healthy Volunteers

Yes

Conditions

Interventions

DIAGNOSTIC_TEST

Dental plaque sample

Dental plaque sample

DIAGNOSTIC_TEST

Saliva sample

Saliva sample using a swab

Locations (1)

Assistance Publique Hopitaux de Marseille

Marseille, France