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Dysbiosis of Methanogenic Archaea and Nanoarchaea in the Oral Microbiome

NCT07521644 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2026-04-13

No results posted yet for this study

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

Conditions

  • Oral Health

Interventions

DIAGNOSTIC_TEST

Dental plaque sample

Dental plaque sample

DIAGNOSTIC_TEST

Saliva sample

Saliva sample using a swab

Sponsors & Collaborators

  • Assistance Publique Hopitaux De Marseille

    lead OTHER

Principal Investigators

  • Mathilde LEFEVRE · Assistance Publique Hopitaux De Marseille

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2029-09-01
Completion
2029-12-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07521644 on ClinicalTrials.gov