Periodontitis Clinical Trial
— NT21Official title:
Study of Neutrophils During Gingival Inflammation in Children With Down Syndrome/Trisomy 21
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.
Status | Not yet recruiting |
Enrollment | 18 |
Est. completion date | March 13, 2025 |
Est. primary completion date | March 13, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years to 12 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Carles-Foix Hospital | Ivry-sur-Seine |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Distinction of neutrophil subtypes according to co-expression of markers of neutrophil function among a panel of 24 markers by flow cytometry | purification od neutrophils from blood and saliva Fixation Cell sorting using FACS on a panel of 24 markers | 1 year | |
Secondary | Evaluation of neutrophil subtypes present in saliva and study of a correlation with blood neutrophils during periodontal health and periodontal inflammation (intra individual analysis) | Correlation with previous results | 1 year |
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