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

Periodontitis Clinical Trial

— NT21  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05970965
• Other study ID #: APHP230786
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 13, 2024
• Est. completion date: March 13, 2025

Study information

• Verified date: October 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Marjolaine Ms GOSSET, PU-PH
• Phone: 0149594811
• Email: marjolaine.gosset[@]aphp.fr; marjolaine.gosset[@]u-paris.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 18
• Est. completion date: March 13, 2025
• Est. primary completion date: March 13, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Down Syndrome
• Inflammation
• Periodontitis
• Trisomy 21

Intervention

Procedure:
• Biological sampling
- Saliva and blood sampling

Locations

Country	Name	City	State
France	Carles-Foix Hospital	Ivry-sur-Seine

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 year
Secondary	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	1 year