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

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05970965

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

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.

Our primary objective is to characterize the different oral and blood neutrophil subtypes in DS/T21 children with gingival inflammation.

Our 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: Screening visit (J-21) Procedure: Inclusion visit (J0)	N/A

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 their periodontal health, and CONTROLS: Group 2 divided into 4 subgroups according to their 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

Study Type:

Interventional

Anticipated 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

Anticipated Study Start Date :

Sep 13, 2023

Anticipated Primary Completion Date :

Sep 13, 2024

Anticipated Study Completion Date :

Sep 13, 2024

Arms and Interventions

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: Screening visit (J-21) - Selection and information of patients and parental guardians during a care visit. Procedure: Inclusion visit (J0) Inclusion of patients following information and consent of parental guardians. Oral hygiene instruction (as part of treatment) Scaling if necessary (as part of treatment) Saliva and blood sampling (for research) If both parents are present, the inclusion visit and selection visit can take place on the same day, if the patient does not need to return for treatment.

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: Screening visit (J-21)

- Selection and information of patients and parental guardians during a care visit.

Procedure: Inclusion visit (J0)

Inclusion of patients following information and consent of parental guardians. Oral hygiene instruction (as part of treatment) Scaling if necessary (as part of treatment) Saliva and blood sampling (for research) If both parents are present, the inclusion visit and selection visit can take place on the same day, if the patient does not need to return for treatment.

Outcome Measures

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 [1 year]
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) [1 year]
Correlation with previous results

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 12 Years

Sexes Eligible for Study:

All

Accepts 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