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

Not Applicable

Recruiting

• Conditions: Trisomy 21; Periodontitis

• Registration Number: NCT05970965
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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.

Study Timeline

• Study First Submitted: 2023-07-24
• Study First Submitted QC: 2023-07-24
• Study First Posted: 2023-08-02
• Study Start: 2025-04-30
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-02
• Last Update Posted: 2025-05-06
• Primary Completion: 2027-04-30
• Study Completion: 2027-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Distinction of neutrophil subtypes according to co-expression of markers of neutrophil function among a panel of 24 markers by flow cytometry	1 year	purification od neutrophils from blood and saliva Fixation Cell sorting using FACS on a panel of 24 markers

Secondary Outcome Measures

Name	Time	Method
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	Correlation with previous results

Trial Locations

Locations (1)

Carles-Foix Hospital; 🇫🇷 Ivry-sur-Seine, France