Investigating Periodontitis in Children with Down Syndrome
Study of Neutrophils During Gingival Inflammation in Children With Down Syndrome/Trisomy 21
This study is trying to see how gum disease affects children with Down syndrome by looking at their immune response and comparing it to children with similar developmental challenges.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 3 Years to 12 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Ivry-sur-Seine) |
| Trial ID | NCT05970965 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the relationship between periodontitis and immune response in children with Down syndrome (trisomy 21). It will collect saliva and serum samples from participants to analyze different neutrophil subtypes associated with gingival inflammation. The study will involve two groups: children with Down syndrome and a control group of children with psychomotor retardation. The primary focus is on understanding how specific neutrophil phenotypes may contribute to the progression of periodontitis in these patients.
Who should consider this trial
Good fit: Ideal candidates are children aged 3 to 12 with Down syndrome and varying periodontal health statuses.
Not a fit: Patients with conditions unrelated to Down syndrome or those outside the specified age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to better understanding and management of periodontal disease in children with Down syndrome.
How similar studies have performed: While studies have explored periodontitis in various populations, this specific focus on Down syndrome and neutrophil phenotypes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ivry-sur-Seine
- Carles-Foix Hospital — Ivry-sur-Seine, France (Recruiting)
Study contacts
- Principal investigator: Marjolaine Ms GOSSET, PU-PH — Aphp
- Study coordinator: Marjolaine Ms GOSSET, PU-PH
- Email: marjolaine.gosset@aphp.fr; marjolaine.gosset@u-paris.fr
- Phone: 0149594811
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.