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

NCT ID: NCT05970965

Last Updated: 2025-05-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-30
• Study Completion Date: 2027-04-30

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.

Conditions

Periodontitis; Trisomy 21

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

Biological sampling

Intervention Type: PROCEDURE

\- Saliva and blood sampling

Interventions

Biological sampling

\- Saliva and blood sampling

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marjolaine Ms GOSSET, PU-PH

Role: PRINCIPAL_INVESTIGATOR

APHP

Locations

Carles-Foix Hospital

Ivry-sur-Seine, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Marjolaine Ms GOSSET, PU-PH

Role: CONTACT

marjolaine.gosset@aphp.fr; marjolaine.gosset@u-paris.fr

0149594811

Anne Laure Ms BONNET, MCU-PH

Role: CONTACT

anne-laure.bonnet@aphp.fr

0149594811

Facility Contacts

Marjolaine Ms GOSSET, PU-PH

Role: primary

marjolaine.gosset@u-paris.fr; marjolaine.gosset@aphp.fr

0149594811

Anne Laure BONNET, MCU-PH

Role: backup

anne-laure.bonnet@aphp.fr

0149594811

Other Identifiers

APHP230786

Identifier Type: -

Identifier Source: org_study_id