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NCT Number: NCT05970965

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

biological sampling

Procedure
  • Saliva and blood sampling

Primary outcomes

  1. Distinction of neutrophil subtypes according to co-expression of markers of neutrophil function among a panel of 24 markers by flow cytometry

    Time frame: 1 year

    purification od neutrophils from blood and saliva Fixation Cell sorting using FACS on a panel of 24 markers

Secondary outcomes

  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)

    Time frame: 1 year

    Correlation with previous results

Study contacts

Contact information is provided by the study sponsor or research team.

Anne Laure Ms BONNET, MCU-PH

CONTACT

[email protected]

0149594811

Marjolaine Ms GOSSET, PU-PH

CONTACT

[email protected]; [email protected]

0149594811

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: NT21

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 2, 2023
Registry last updated
May 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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