Status:
RECRUITING
Periodontitis and Inflammation in Children With Down Syndrome/Trisomy 21: Study on Biological Samples
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Periodontitis
Trisomy 21
Eligibility:
All Genders
3-12 years
Phase:
NA
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 repo...
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 ...
Eligibility Criteria
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
- 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
Key Trial Info
Start Date :
April 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2027
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT05970965
Start Date
April 30 2025
End Date
April 30 2027
Last Update
May 6 2025
Active Locations (1)
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1
Carles-Foix Hospital
Ivry-sur-Seine, France, 94200