Clinical Trial

Dysbiosis of Methanogenic Archaea and Nanoarchaea in the Oral Microbiome

Study acronym: METHAORAL
Not Yet Recruiting
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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
Trial Details
NCT Number NCT07521644
Lead Sponsor Assistance Publique Hopitaux De Marseille
Conditions Oral Health
Enrollment 250 participants
Start Date 2026-09-01
Primary Completion 2029-09-01 (estimated)
Study Completion 2029-12-01 (estimated)
Updated on ClinicalTrials.gov 2026-04-13