NCT05970965 Periodontitis and Inflammation in Children With Down Syndrome/Trisomy 21: Study on Biological Samples
| NCT ID | NCT05970965 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Periodontitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 18 participants |
| Start Date | 2025-04-30 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 18 participants in total. It began in 2025-04-30 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Marjolaine Ms GOSSET, PU-PH
PRINCIPAL INVESTIGATOR
APHP
Frequently Asked Questions
Who can join the NCT05970965 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 12 Years, studying Periodontitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05970965 currently recruiting?
Yes, NCT05970965 is actively recruiting participants. Contact the research team at marjolaine.gosset@aphp.fr; marjolaine.gosset@u-paris.fr for enrollment information.
Where is the NCT05970965 trial being conducted?
This trial is being conducted at Ivry-sur-Seine, France.
Who is sponsoring the NCT05970965 clinical trial?
NCT05970965 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Marjolaine Ms GOSSET, PU-PH at APHP. The trial plans to enroll 18 participants.