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

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Jul 24, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how children with Down syndrome (also known as Trisomy 21) experience gum disease, called periodontitis. Researchers want to understand the different types of immune cells, specifically neutrophils, in these children and how they might affect the development and progression of gum inflammation. Many young individuals with Down syndrome show early signs of gum disease, and this study aims to shed light on the reasons why this happens more quickly in them compared to other children.

To participate, children aged 3 to 12 with Down syndrome can be included if they have either gum inflammation or healthy gums. There are also control groups for children with other conditions or healthy children. It’s important that parents or guardians can read and understand the study information in French and provide written consent for their child to join. Participants can expect to provide blood and oral samples, which will help researchers learn more about the immune system's role in gum health and disease in children with Down syndrome.

Gender

ALL

Eligibility criteria

• 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