Actively Recruiting
Periodontitis and Inflammation in Children With Down Syndrome/Trisomy 21: Study on Biological Samples
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-05-06
18
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Periodontitis and Inflammation in Children With Down Syndrome/Trisomy 21: Study on Biological Samples
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 3 and 12 years
- Patient affiliated with a social security program, not covered by AME
- Legal representatives who speak and understand French well enough to read and understand study information
- Legal representatives provide written consent for the child's participation
- For case group: child with trisomy 21 and gingival inflammation or healthy gingiva with no history of periodontitis
- For control group: child with psychomotor retardation without orofacial or immune issues with gingival inflammation or healthy gingiva, or child with no known general pathology with gingival inflammation or healthy gingiva
You will not qualify if you...
- Received antibiotic prophylaxis, antibiotic therapy, or anti-inflammatory treatment within 3 months before inclusion
- Participating in another interventional research protocol or in a period of exclusion
- Covered by AME
- Contraindications to MEOPA including need for pure oxygen ventilation, intracranial hypertension, unevaluated head trauma, unexplained neurological abnormalities, pneumothorax, emphysema bubbles, gas embolism, diving accident, abdominal gas distension or occlusion, recent ophthalmic gas treatment, or known unsubstituted vitamin B12 deficiency
- For trisomy 21 group: no genetic diagnosis
AI-Screening
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Trial Site Locations
Total: 1 location
1
Carles-Foix Hospital
Ivry-sur-Seine, France, 94200
Actively Recruiting
Research Team
M
Marjolaine Ms GOSSET, PU-PH
CONTACT
A
Anne Laure Ms BONNET, MCU-PH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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