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Since 2018, the Chicago Classification of Periodontal Diseases and Conditions, has listed Down syndrome (DS)/trisomy 21 (T21) as a systemic disease with periodontal implications. Numerous studies report an increased prevalence and severity of periodontitis in DS/T21 individuals under the age of 35. Approximately 35% of adolescents with DS show early signs of alveolar bone loss. However, very few studies have examined the role of immune deficiency in DS/T21 patients in the pathogenesis of periodontitis. Indeed, periodontitis induced by bacterial plaque is virtually non-existent in the paediatric population, leaving the field to systemically-induced periodontitis.
The investigators hypothesize that specific neutrophil phenotypes in DS/T21 patients are key to explaining the rapid progression to periodontitis.
Investigator's primary objective is to characterize the different oral and blood neutrophil subtypes in DS/T21 children with gingival inflammation.
Investigator's secondary objective is to assess the involvement of different neutrophil subtypes in early periodontitis in children with DS/T21.
It's a cross-sectional, monocenter, prospective, open-label, non-randomized case control study to collect saliva and serum samples as part of the patient's routine care in oral medicine department to form a biological collection.
Patients will be recruited in the oral medicine department of AP-HP Charles Foix hospital (Ivry/Seine) by periodontists in 2 groups (CASES: Group 1 for children with DS/T21 divided into 2 subgroups according the periodontal health, and CONTROLS: Group 2 divided into 4 subgroups according to the systemic and periodontal health) Inclusion period is 12 months. There is no specific follow-up due to the research.
Assessment criteria:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Child patient consulting the service | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biological sampling | Procedure | - Saliva and blood sampling |
|
| Measure | Description | Time Frame |
|---|---|---|
| Distinction of neutrophil subtypes according to co-expression of markers of neutrophil function among a panel of 24 markers by flow cytometry | purification od neutrophils from blood and saliva Fixation Cell sorting using FACS on a panel of 24 markers | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of neutrophil subtypes present in saliva and study of a correlation with blood neutrophils during periodontal health and periodontal inflammation (intra individual analysis) | Correlation with previous results | 1 year |
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Inclusion Criteria:
Common to all groups:
Specific:
Case Group:
Control Group: child meeting one of these criteria:
Exclusion Criteria:
Common to all groups:
Patient having received antibiotic prophylaxis, antibiotic therapy or anti-inflammatory treatment in the 3 months prior to inclusion
Patient included in another interventional research protocol or in a period of exclusion.
Patient on AME
Patients with a contraindication to the use of MEOPA:
Specific to Trisomy 21 group:
- Patient with no genetic diagnosis
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marjolaine Ms GOSSET, PU-PH | Contact | 0149594811 | marjolaine.gosset@aphp.fr; marjolaine.gosset@u-paris.fr | |
| Anne Laure Ms BONNET, MCU-PH | Contact | 0149594811 | anne-laure.bonnet@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Marjolaine Ms GOSSET, PU-PH | APHP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carles-Foix Hospital | Recruiting | Ivry-sur-Seine | 94200 | France |
Data are available upon reasonable request :
The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients.
Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
Researchers who provide a methodologically sound proposal.
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D004314 | Down Syndrome |
| D011596 | Psychomotor Disorders |
| D005891 | Gingivitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D008607 | Intellectual Disability |
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| D019954 |
| Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D025063 | Chromosome Disorders |
| D030342 | Genetic Diseases, Inborn |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007239 | Infections |
| D005882 | Gingival Diseases |