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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A02266-43 | Other Identifier | ANSM |
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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:
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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individuals with periodontal vulnerability | Sham Comparator | those over 60 without periodontal disease and/or who are immunocompromised |
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| Control group | Active Comparator | individuals under 60 without periodontal disease |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dental plaque sample | Diagnostic Test | Dental plaque sample |
|
| Measure | Description | Time Frame |
|---|---|---|
| Estimate the prevalence of dysbiosis | Estimate the prevalence of dysbiosis in the two populations based on dental plaque sample | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Estimate the prevalence of dysbiosis i | Estimate the prevalence of dysbiosis in the two populations based on a saliva sample | 3 years |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| alexandra GIULIANI | Contact | +33491382870 | alexandra.giuliani@ap-hm.fr |
| Name | Affiliation | Role |
|---|---|---|
| Mathilde LEFEVRE | Assistance Publique Hopitaux De Marseille | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assistance Publique Hopitaux de Marseille | Marseille | France |
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| Saliva sample | Diagnostic Test | Saliva sample using a swab |
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