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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05970965
Other study ID # APHP230786
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 13, 2024
Est. completion date March 13, 2025

Study information

Verified date October 2023
Source Assistance Publique - Hôpitaux de Paris
Contact Marjolaine Ms GOSSET, PU-PH
Phone 0149594811
Email marjolaine.gosset@aphp.fr; marjolaine.gosset@u-paris.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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: - Primary criteria: Neutrophil subtypes analysis based on co-expression of neutrophil function markers from a panel of 24 markers by flow cytometry. - Secondary criteria: assessment of neutrophil sub-types present in the patient's saliva and study of the correlation within blood neutrophils, during periodontal health, gingivitis and periodontitis.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 18
Est. completion date March 13, 2025
Est. primary completion date March 13, 2025
Accepts healthy volunteers No
Gender All
Age group 3 Years to 12 Years
Eligibility Inclusion Criteria: Common to all groups: - Age: 3 to 12 - Patient affiliated to a social security program, beneficiary not covered by the AME. - Legal representatives who speak and understand French well enough to be able to read and understand the study information. - Legal representatives giving written consent for their child's participation in the study. Specific: Case Group: - Trisomy 21 patient with gingival inflammation (subgroup 1) - Trisomy 21 patient with healthy gingiva on intact periodontium with no history of periodontitis (subgroup 2) Control Group: child meeting one of these criteria: - Patient with psychomotor retardation with no known repercussions on the orofacial sphere or immunity, presenting gingival inflammation (subgroup 1) - Patients with psychomotor retardation and no known repercussions on orofacial health or immunity, presenting gingival health on intact periodontium with no history of gingival inflammation (subgroup 2). - Patients with no known general pathology and gingival inflammation (subgroup 3) - Patients with no known general pathology and healthy gingiva on intact periodontium with no history of gingival inflammation (subgroup 4) 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: - Patients requiring pure oxygen ventilation - Intracranial hypertension - Unevaluated head trauma - New-onset, unexplained neurological abnormalities - Pneumothorax - Emphysema bubbles - Gas embolism - Diving accident - Abdominal gas distension, occlusion - Patient recently treated with ophthalmic gas (SF6, C3F8, C2F6) - Known, unsubstituted vitamin B12 deficiency Specific to Trisomy 21 group: - Patient with no genetic diagnosis

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Biological sampling
- Saliva and blood sampling

Locations

Country Name City State
France Carles-Foix Hospital Ivry-sur-Seine

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary 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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