Periodontitis and Inflammation in Children With Down Syndrome/Trisomy 21: Study on Biological Samples
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-12
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 requiring pure oxygen ventilation
Trial design
Design model
Single group
Treatments tested in this trial
Biological sampling
Procedure/Surgery\- Saliva and blood sampling
Treatment groups
18 Participants
are divided into 1 treatment groupGroup A: Child patient consulting the serviceExperimental treatment 1 intervention
Trial outcomes
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
Time frame
1 yearSecondary 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)
Correlation with previous results
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov