Assistance Publique Hopitaux de Marseille
Marseille, France
Location contact
elodie TERREE, PU-PH
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07521644
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 opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Marseille, France
elodie TERREE, PU-PH
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Case selection criteria:
Cases are defined as subjects with oral health vulnerability
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.
Exclusion criteria
Dental plaque sample
Saliva sample using a swab
Time frame: 3 years
Estimate the prevalence of dysbiosis in the two populations based on dental plaque sample
Time frame: 3 years
Estimate the prevalence of dysbiosis in the two populations based on a saliva sample
Contact information is provided by the study sponsor or research team.
Assistance Publique Hopitaux De Marseille
Other
Acronym: METHAORAL
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