Periodontitis and Inflammation in Children With Down Syndrome/Trisomy 21: Study on Biological Samples

Официальное название

Study of Neutrophils During Gingival Inflammation in Children With Down Syndrome/Trisomy 21

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Biological sampling
  \- Saliva and blood sampling

Первичные конечные точки

• Distinction of neutrophil subtypes according to co-expression of markers of neutrophil function among a panel of 24 markers by flow cytometry [Срок оценки: 1 year]

Вторичные конечные точки (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) [Срок оценки: 1 year]

Критерии участия

Критерии включения

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)

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

Франция · 1 центр

• Carles-Foix Hospital — Ivry-sur-Seine

Идентификаторы

NCT: NCT05970965 · APHP230786

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗