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Periodontitis and Inflammation in Children With Down Syndrome/Trisomy 21: Study on Biological Samples

Study of Neutrophils During Gingival Inflammation in Children With Down Syndrome/Trisomy 21

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05970965
Acronym
NT21
Enrollment
18
Registered
2023-08-02
Start date
2025-04-30
Completion date
2027-04-30
Last updated
2025-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontitis, Trisomy 21

Keywords

Down syndrome, Trisomy 21, psychomotor retardation, gingivitis, periodontitis, neutrophils, biological collection

Brief 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.

Detailed 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.

Interventions

PROCEDUREBiological sampling

\- Saliva and blood sampling

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
3 Years to 12 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Distinction of neutrophil subtypes according to co-expression of markers of neutrophil function among a panel of 24 markers by flow cytometry1 yearpurification od neutrophils from blood and saliva Fixation Cell sorting using FACS on a panel of 24 markers

Secondary

MeasureTime frameDescription
Evaluation of neutrophil subtypes present in saliva and study of a correlation with blood neutrophils during periodontal health and periodontal inflammation (intra individual analysis)1 yearCorrelation with previous results

Countries

France

Contacts

Primary ContactMarjolaine Ms GOSSET, PU-PH
marjolaine.gosset@aphp.fr; marjolaine.gosset@u-paris.fr0149594811
Backup ContactAnne Laure Ms BONNET, MCU-PH
anne-laure.bonnet@aphp.fr0149594811

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026