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

Last updated: May 2, 2025
Sponsor: Assistance Publique - Hôpitaux de Paris
Overall Status: Active - Recruiting

Phase

N/A

Condition

Down's Syndrome

Inflammation

Periodontitis

Treatment

Inclusion visit (J0)

Screening visit (J-21)

Biological sampling

Clinical Study ID

NCT05970965
APHP230786
  • Ages 3-12
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 readand understand the study information.

  • Legal representatives giving written consent for their child's participation in thestudy.

Specific:

Case Group:

  • Trisomy 21 patient with gingival inflammation (subgroup 1)

  • Trisomy 21 patient with healthy gingiva on intact periodontium with no history ofperiodontitis (subgroup 2)

Control Group: child meeting one of these criteria:

  • Patient with psychomotor retardation with no known repercussions on the orofacialsphere or immunity, presenting gingival inflammation (subgroup 1)

  • Patients with psychomotor retardation and no known repercussions on orofacial healthor immunity, presenting gingival health on intact periodontium with no history ofgingival 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 periodontiumwith no history of gingival inflammation (subgroup 4)

Exclusion

Exclusion Criteria:

Common to all groups:

  • Patient having received antibiotic prophylaxis, antibiotic therapy oranti-inflammatory treatment in the 3 months prior to inclusion

  • Patient included in another interventional research protocol or in a period ofexclusion.

  • 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

Total Participants: 18
Treatment Group(s): 3
Primary Treatment: Inclusion visit (J0)
Phase:
Study Start date:
April 30, 2025
Estimated Completion Date:
April 30, 2027

Study 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.

Connect with a study center

  • Carles-Foix Hospital

    Ivry-sur-Seine, 94200
    France

    Active - Recruiting

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