Periodontitis and Inflammation in Children With Down Syndrome/Trisomy 21: Study on Biological Samples
Recruiting now · Not applicable
Conditions studied: Periodontitis, Trisomy 21
In brief
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.
Key facts
- Study ID
- NCT05970965
- Run by
- Assistance Publique - Hôpitaux de Paris
- People needed
- 18
- Starts
- 2025-04-30
- Expected to finish
- 2027-04-30
- Last updated by the study team
- 2025-05-06
Who can join
Age: 3 and older, up to 12. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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 is running
- Carles-Foix Hospital — Ivry-sur-Seine, France (enrolling)
Full record on ClinicalTrials.gov
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