Carles-Foix Hospital
Ivry-sur-Seine, 94200, France
Location status: Recruiting
Location contact
Anne Laure BONNET, MCU-PH
CONTACT
Marjolaine Ms GOSSET, PU-PH
CONTACT
NCT Number: NCT05970965
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.
Interested in participating?
Request Info3 year–12 year
All sexes
Interventional
Not applicable
Ivry-sur-Seine, 94200, France
Location status: Recruiting
Anne Laure BONNET, MCU-PH
CONTACT
Marjolaine Ms GOSSET, PU-PH
CONTACT
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Common to all groups:
Specific:
Case Group:
Control Group: child meeting one of these criteria:
Exclusion criteria
Common to all groups:
Specific to Trisomy 21 group:
Time frame: 1 year
purification od neutrophils from blood and saliva Fixation Cell sorting using FACS on a panel of 24 markers
Time frame: 1 year
Correlation with previous results
Contact information is provided by the study sponsor or research team.
Anne Laure Ms BONNET, MCU-PH
CONTACT
Marjolaine Ms GOSSET, PU-PH
CONTACT
Assistance Publique - Hôpitaux de Paris
Other
Study of Neutrophils During Gingival Inflammation in Children With Down Syndrome/Trisomy 21
Acronym: NT21
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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