Status:

RECRUITING

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

Lead Sponsor:

Assistance Publique - Hôpitaux de Paris

Conditions:

Periodontitis

Trisomy 21

Eligibility:

All Genders

3-12 years

Phase:

NA

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 repo...

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 ...

Eligibility Criteria

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

Key Trial Info

Start Date :

April 30 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

April 30 2027

Estimated Enrollment :

18 Patients enrolled

Trial Details

Trial ID

NCT05970965

Start Date

April 30 2025

End Date

April 30 2027

Last Update

May 6 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Carles-Foix Hospital

Ivry-sur-Seine, France, 94200