Oral HealthMETHAORALNCT07521644
Dysbiosis of Methanogenic Archaea and Nanoarchaea in the Oral Microbiome
A study testing Dental plaque sample and Saliva sample in people with Oral Health, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oral Health
- What is being tested?
- Dental plaque sample and Saliva sample
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2026to 1 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Assistance Publique Hopitaux de Marseille
Marseille
elodie TERREE, PU-PH
About this study
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.
Read more
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
Read the detailed description
Study Design A cross-sectional case-control study. Participation in the study will be offered to all eligible subjects who meet the inclusion criteria.
Number of Patients 250 patients. For each patient, a dental plaque sample and a saliva sample will be collected during the visit.
- Conditions
- Oral Health
- Being tested
- Dental plaque sample, Saliva sample
- Keywords
- oral health issues, without oral health issues
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental plaque sampleDiagnostic test
Dental plaque sample
Saliva sampleDiagnostic test
Saliva sample using a swab
| Study group | Role | What they receive |
|---|---|---|
| Individuals with periodontal vulnerability | Sham comparator | those over 60 without periodontal disease and/or who are immunocompromised Receives: Diagnostic Test: Dental plaque sample; Diagnostic Test: Saliva sample |
| Control group | Active comparator | individuals under 60 without periodontal disease Receives: Diagnostic Test: Dental plaque sample; Diagnostic Test: Saliva sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimate the prevalence of dysbiosis
Estimate the prevalence of dysbiosis in the two populations based on dental plaque sample
Measured: 3 years
Secondary outcomes (1)
Estimate the prevalence of dysbiosis i
Estimate the prevalence of dysbiosis in the two populations based on a saliva sample
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2029 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral HealthStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mathilde LEFEVRE, Study director, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07521644
- Sponsor's protocol ID
- RCAPHM25_0384
- Other IDs
- 2025-A02266-43
- Acronym
- METHAORAL
- Status last verified
- Apr 2026
- First submitted
- 30 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dysbiosis of Methanogenic Archaea and Nanoarchaea in the Oral Microbiome
- ClinicalTrials.gov ID
- NCT07521644
- Acronym / sponsor ID
- METHAORAL / RCAPHM25_0384
- Conditions
- Oral Health
- Keywords
- oral health issues, without oral health issues
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2029 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Study Design A cross-sectional case-control study. Participation in the study will be offered to all eligible subjects who meet the inclusion criteria.
Number of Patients 250 patients. For each patient, a dental plaque sample and a saliva sample will be collected during the visit.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individuals with periodontal vulnerability | Sham comparator | Diagnostic Test: Dental plaque sample, Diagnostic Test: Saliva samplethose over 60 without periodontal disease and/or who are immunocompromised |
| Control group | Active comparator | Diagnostic Test: Dental plaque sample, Diagnostic Test: Saliva sampleindividuals under 60 without periodontal disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dental plaque sampleDental plaque sample | Diagnostic test | Control group, Individuals with periodontal vulnerability |
| Saliva sampleSaliva sample using a swab | Diagnostic test | Control group, Individuals with periodontal vulnerability |
Primary outcome
Estimate the prevalence of dysbiosis
Time frame: 3 years
Estimate the prevalence of dysbiosis in the two populations based on dental plaque sample
1 secondary outcome
Estimate the prevalence of dysbiosis i
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mathilde LEFEVRE study director
Assistance Publique Hopitaux De Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dental plaque sample and Saliva sample in people with Oral Health, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact alexandra GIULIANI (+33491382870, alexandra.giuliani@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimate the prevalence of dysbiosis (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.