Study of Neutrophils During Gingival Inflammation in Children With Down Syndrome/Trisomy 21
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Distinction of neutrophil subtypes according to co-expression of markers of neutrophil function among a panel of 24 markers by flow cytometry
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •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)
排除标准
- •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
结局指标
主要结局
Distinction of neutrophil subtypes according to co-expression of markers of neutrophil function among a panel of 24 markers by flow cytometry
时间窗: 1 year
purification od neutrophils from blood and saliva Fixation Cell sorting using FACS on a panel of 24 markers
次要结局
- Evaluation of neutrophil subtypes present in saliva and study of a correlation with blood neutrophils during periodontal health and periodontal inflammation (intra individual analysis)(1 year)