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

NCT05970965 | Recruiting

• 1 other identifier: APHP230786
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis; Trisomy 21

Keywords

Down syndrome; Trisomy 21; psychomotor retardation; gingivitis; periodontitis; neutrophils; biological collection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (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)

  1 year

Study Arms (1)

Child patient consulting the service

EXPERIMENTAL

* 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

Interventions

Biological sampling PROCEDURE

\- Saliva and blood sampling

Child patient consulting the service

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• Common to all groups:
• 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:

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Carles-Foix Hospital

Ivry-sur-Seine, 94200, France

RECRUITING

MeSH Terms

Conditions

Periodontitis; Down Syndrome; Psychomotor Disorders; Gingivitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infections; Gingival Diseases

Study Officials

• Marjolaine Ms GOSSET, PU-PH

  APHP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marjolaine Ms GOSSET, PU-PH

CONTACT

0149594811; marjolaine.gosset@aphp.fr; marjolaine.gosset@u-paris.fr

Anne Laure Ms BONNET, MCU-PH

CONTACT

0149594811; anne-laure.bonnet@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: August 2, 2023
• Study Start: April 30, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: May 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

FR (1)