Dysbiosis of Methanogenic Archaea and Nanoarchaea in the Oral Microbiome

ConditionOral Health

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorAssistance Publique Hopitaux De Marseille

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Men or women aged 60 years or older

and/or immunocompromised individuals without periodontal disease (gingivitis, periodontitis, and peri-implantitis) clinically diagnosed by the dentist during the consultation.

Patients who have received information about the study and have not expressed objection

Patients who are beneficiaries or eligible for a social security program Control group selection criteria Controls are defined as subjects without oral health vulnerability • Men and women under 60 years of age without periodontal disease (gingivitis, periodontitis, and peri-implantitis) clinically diagnosed by the dentist during the consultation.

Disqualifiers

Patients who are currently excluded from another research protocol at the time the informed consent form is collected.

Subjects covered by Articles L1121-5 through L1121-8 of the Public Health Code (minors, adults under guardianship or conservatorship, patients deprived of their liberty, pregnant or breastfeeding women),

Men and women with periodontal disease (gingivitis, periodontitis, and peri-implantitis)

Men and women with any systemic disease

Trial design

Design model

Parallel

Treatments tested in this trial

Dental plaque sample
Diagnostic test
Dental plaque sample
Saliva sample
Diagnostic test
Saliva sample using a swab

Treatment groups

250 Participants

are divided into 2 treatment groups

Group A: Individuals with periodontal vulnerabilitySham comparator 2 interventions

Group B: Control groupActive comparator 2 interventions

Trial outcomes

Primary outcomes

Estimate the prevalence of dysbiosis

Estimate the prevalence of dysbiosis in the two populations based on dental plaque sample

Time frame

3 years

Secondary outcomes

Estimate the prevalence of dysbiosis i

Estimate the prevalence of dysbiosis in the two populations based on a saliva sample

Time frame

3 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique Hopitaux De Marseille

Lead sponsor

Source ClinicalTrials.gov

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