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

Primary Purpose

Periodontitis, Trisomy 21

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Biological sampling
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Periodontitis focused on measuring Down syndrome, Trisomy 21, psychomotor retardation, gingivitis, periodontitis, neutrophils, biological collection

Eligibility Criteria

3 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Carles-Foix Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Child patient consulting the service

Arm Description

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)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Evaluation of neutrophil subtypes present in saliva and study of a correlation with blood neutrophils during periodontal health and periodontal inflammation (intra individual analysis)
Correlation with previous results

Full Information

First Posted
July 24, 2023
Last Updated
August 21, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT05970965
Brief Title
Periodontitis and Inflammation in Children With Down Syndrome/Trisomy 21: Study on Biological Samples
Acronym
NT21
Official Title
Study of Neutrophils During Gingival Inflammation in Children With Down Syndrome/Trisomy 21
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 13, 2023 (Anticipated)
Primary Completion Date
September 13, 2024 (Anticipated)
Study Completion Date
September 13, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Trisomy 21
Keywords
Down syndrome, Trisomy 21, psychomotor retardation, gingivitis, periodontitis, neutrophils, biological collection

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Child patient consulting the service
Arm Type
Experimental
Arm Description
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)
Intervention Type
Procedure
Intervention Name(s)
Biological sampling
Intervention Description
- Saliva and blood sampling
Primary Outcome Measure Information:
Title
Distinction of neutrophil subtypes according to co-expression of markers of neutrophil function among a panel of 24 markers by flow cytometry
Description
purification od neutrophils from blood and saliva Fixation Cell sorting using FACS on a panel of 24 markers
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Evaluation of neutrophil subtypes present in saliva and study of a correlation with blood neutrophils during periodontal health and periodontal inflammation (intra individual analysis)
Description
Correlation with previous results
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marjolaine Ms GOSSET, PU-PH
Phone
0149594811
Email
marjolaine.gosset@aphp.fr; marjolaine.gosset@u-paris.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Anne Laure Ms BONNET, MCU-PH
Phone
0149594811
Email
anne-laure.bonnet@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marjolaine Ms GOSSET, PU-PH
Organizational Affiliation
APHP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carles-Foix Hospital
City
Ivry-sur-Seine
ZIP/Postal Code
94200
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marjolaine Ms GOSSET, PU-PH
Phone
0149594811
Email
marjolaine.gosset@u-paris.fr; marjolaine.gosset@aphp.fr
First Name & Middle Initial & Last Name & Degree
Anne Laure BONNET, MCU-PH
Phone
0149594811
Email
anne-laure.bonnet@aphp.fr

12. IPD Sharing Statement

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

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