Investigating Periodontitis in Children with Down Syndrome
Official title: Study of Neutrophils During Gingival Inflammation in Children With Down Syndrome/Trisomy 21
Run by Assistance Publique - Hôpitaux de Paris · NCT05970965 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 3 Years to 12 Years |
| Sex | All |
| Enrollment | 18 (estimated) |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Ivry-sur-Seine) |
| Status | Recruiting |
| Started | April 30, 2025 |
| Main results expected | April 30, 2027 |
| Study ends | April 30, 2027 |
| Registry record updated | May 6, 2025 |
| Trial ID | NCT05970965 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 3 to 12 with Down syndrome and varying periodontal health statuses.
✕Probably not a fit
Patients with conditions unrelated to Down syndrome or those outside the specified age range may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While studies have explored periodontitis in various populations, this specific focus on Down syndrome and neutrophil phenotypes is relatively novel.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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This study tests how common high BMI and periodontitis are among Thai adults aged 18–59 and what factors are linked to them.
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Periodontal Infection and Inflammatory Markers in Missed Abortion
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This study tests whether using dental loupes or a dental operating microscope makes non-surgical periodontal cleaning more effective for adults with periodontitis.
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Boron, Oxidative Stress, and Inflammation in Periodontitis
This observational study compares boron levels and inflammation markers in saliva and gum tissue between people with periodontitis and healthy controls to see if boron relates to gum inflammation.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.