Periodontitis and Inflammation in Children With Down Syndrome/Trisomy 21: Study on Biological Samples
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biological sampling.
- Who it may be relevant to
- Registry conditions: Periodontitis, Trisomy 21. Basic parameters: 3 years — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Study of Neutrophils During Gingival Inflammation in Children With Down Syndrome/Trisomy 21
Overview
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.
Detailed description
It's a cross-sectional, monocenter, prospective, open-label, non-randomized case control study to collect saliva and serum samples as part of the patient's routine care in oral medicine department to form a biological collection.
Patients will be recruited in the oral medicine department of AP-HP Charles Foix hospital (Ivry/Seine) by periodontists in 2 groups (CASES: Group 1 for children with DS/T21 divided into 2 subgroups according the periodontal health, and CONTROLS: Group 2 divided into 4 subgroups according to the systemic and periodontal health) Inclusion period is 12 months. There is no specific follow-up due to the research.
Assessment criteria:
* Primary criteria: Neutrophil subtypes analysis based on co-expression of neutrophil function markers from a panel of 24 markers by flow cytometry. * Secondary criteria: assessment of neutrophil sub-types present in the patient's saliva and study of the correlation within blood neutrophils, during periodontal health, gingivitis and periodontitis.
Interventions
- Procedure Biological sampling
\- Saliva and blood sampling
Primary outcome measures
- Distinction of neutrophil subtypes according to co-expression of markers of neutrophil function among a panel of 24 markers by flow cytometry [Time frame: 1 year]
Secondary outcome measures (1)
- Evaluation of neutrophil subtypes present in saliva and study of a correlation with blood neutrophils during periodontal health and periodontal inflammation (intra individual analysis) [Time frame: 1 year]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
France · 1 center
- Carles-Foix Hospital — Ivry-sur-Seine
Identifiers
NCT: NCT05970965 · APHP230786