Dysbiosis of Methanogenic Archaea and Nanoarchaea in the Oral Microbiome

NCT07521644 | Not Yet Recruiting

• 2 other identifiers: RCAPHM25_03842025-A02266-43
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

oral health issues; without oral health issues

Outcome Measures

Primary Outcomes (1)

• Estimate the prevalence of dysbiosis

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

  3 years

Secondary Outcomes (1)

• Estimate the prevalence of dysbiosis i

  3 years

Study Arms (2)

Individuals with periodontal vulnerability

SHAM COMPARATOR

those over 60 without periodontal disease and/or who are immunocompromised

Diagnostic Test: Dental plaque sample; Diagnostic Test: Saliva sample

Control group

ACTIVE COMPARATOR

individuals under 60 without periodontal disease

Diagnostic Test: Dental plaque sample; Diagnostic Test: Saliva sample

Interventions

Dental plaque sample DIAGNOSTIC_TEST

Dental plaque sample

Control group; Individuals with periodontal vulnerability

Saliva sample DIAGNOSTIC_TEST

Saliva sample using a swab

Control group; Individuals with periodontal vulnerability

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Case selection criteria:
• Cases are defined as subjects with oral health vulnerability
• 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.
• The clinical examination allows for the diagnosis of the absence or presence of periodontal disease, with particular attention to: bleeding on probing, the depth of periodontal pocket(s), tooth mobility, bone destruction in furcation areas, and the assessment of radiographic bone level taking age into account.

You may not qualify if:

• 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
• Men and women currently undergoing drug treatment

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, France

Location

Study Officials

• Mathilde LEFEVRE

  Assistance Publique Hopitaux De Marseille

  STUDY DIRECTOR

Central Study Contacts

alexandra GIULIANI

CONTACT

+33491382870; alexandra.giuliani@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 13, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)