Periodontitis and Inflammation in Children With Down Syndrome/Trisomy 21: Study on Biological Samples
Key facts
- Where
- Ivry-sur-Seine, FranceSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 3 and 12 years old?
Source: NCT05970965, who can take part
Where in France
- Carles-Foix HospitalIvry-sur-Seine, FranceContact: Marjolaine Ms GOSSET, PU-PHTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Assistance Publique - Hôpitaux de Paris
- Trial code
- NCT05970965
- Record updated
- 6 May 2025
- Original description
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.Read full original descriptionShow less
Study of Neutrophils During Gingival Inflammation in Children With Down Syndrome/Trisomy 21
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.
Inclusion: 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: Patient having received antibiotic prophylaxis, antibiotic therapy or anti-inflammatory treatment in the 3 months prior to inclusion; 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:; Common to all groups:; Patient included in another interventional research protocol or in a period of exclusion; Patient on AME; Patient with no genetic diagnosis.