Periodontitis and Inflammation in Children With Down Syndrome/Trisomy 21: Study on Biological Samples
- Conditions
- Trisomy 21Periodontitis
- Interventions
- Procedure: Biological sampling
- Registration Number
- NCT05970965
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 18
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)
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Child patient consulting the service Biological sampling * 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)
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (1)
Carles-Foix Hospital
🇫🇷Ivry-sur-Seine, France