Periodontitis and Inflammation in Children With Down Syndrome/Trisomy 21: Study on Biological Sam… (NCT05970965) | Clinical Trial Compass
RecruitingNot Applicable
Periodontitis and Inflammation in Children With Down Syndrome/Trisomy 21: Study on Biological Samples
France18 participantsStarted 2025-04-30
Plain-language 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.
Who can participate
Age range
3 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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 Criteria:
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 c…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Distinction of neutrophil subtypes according to co-expression of markers of neutrophil function among a panel of 24 markers by flow cytometry