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

RecruitingNAAges 3 Years - 12 YearsAllAssistance Publique - Hôpitaux de Paris
NCT05970965 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • Biological sampling
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Where

1 site
Carles-Foix Hospital
Ivry-sur-Seine, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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