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Periodontitis and Inflammation in Children With Down Syndrome/Trisomy 21: Study on Biological Samples (NT21)

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ClinicalTrials.gov Identifier: NCT05970965
Recruitment Status : Not yet recruiting
First Posted : August 2, 2023
Last Update Posted : October 30, 2023
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Periodontitis Trisomy 21 Procedure: Biological sampling Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Study of Neutrophils During Gingival Inflammation in Children With Down Syndrome/Trisomy 21
Estimated Study Start Date : March 13, 2024
Estimated Primary Completion Date : March 13, 2025
Estimated Study Completion Date : March 13, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Down Syndrome

Arms and Interventions
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Arm Intervention/treatment
Experimental: Child patient consulting the service
  • Trisomy 21 patient with gingival inflammation (subgroup 1)
  • Trisomy 21 patient with healthy gingiva on intact periodontium with no history of periodontitis (subgroup 2)
  • 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)
 Procedure: Biological sampling
- Saliva and blood sampling


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05970965


Contacts
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Contact: Marjolaine Ms GOSSET, PU-PH 0149594811 marjolaine.gosset@aphp.fr; marjolaine.gosset@u-paris.fr
Contact: Anne Laure Ms BONNET, MCU-PH 0149594811 anne-laure.bonnet@aphp.fr

Locations
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France
Carles-Foix Hospital
Ivry-sur-Seine, France, 94200
Contact: Marjolaine Ms GOSSET, PU-PH    0149594811    marjolaine.gosset@u-paris.fr; marjolaine.gosset@aphp.fr   
Contact: Anne Laure BONNET, MCU-PH    0149594811    anne-laure.bonnet@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Marjolaine Ms GOSSET, PU-PH APHP
More Information
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT05970965    
Other Study ID Numbers: APHP230786
First Posted: August 2, 2023    Key Record Dates
Last Update Posted: October 30, 2023
Last Verified: October 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Down syndrome
Trisomy 21
psychomotor retardation
gingivitis
 periodontitis
neutrophils
biological collection
Additional relevant MeSH terms:
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Periodontitis
Down Syndrome
Inflammation
Trisomy
Pathologic Processes
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Intellectual Disability
Neurobehavioral Manifestations
 Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Aneuploidy
Chromosome Aberrations
Chromosome Duplication