[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100513860":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":34,"responsibleParty":53,"collaborators":20,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":20,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":76,"overallStatus":37,"whyStopped":20,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Child patient consulting the service","EXPERIMENTAL","* Trisomy 21 patient with gingival inflammation (subgroup 1)\n* Trisomy 21 patient with healthy gingiva on intact periodontium with no history of periodontitis (subgroup 2)\n* Patient with psychomotor retardation with no known repercussions on the orofacial sphere or immunity, presenting gingival inflammation (subgroup 1)\n* 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).\n* Patients with no known general pathology and gingival inflammation (subgroup 3)\n* Patients with no known general pathology and healthy gingiva on intact periodontium with no history of gingival inflammation (subgroup 4)",[13],"Procedure: Biological sampling",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"PROCEDURE","Biological sampling","\\- Saliva and blood sampling",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Marjolaine Ms GOSSET, PU-PH","APHP","PRINCIPAL_INVESTIGATOR",[27,31],{"name":23,"role":28,"phone":29,"phoneExt":20,"email":30},"CONTACT","0149594811","marjolaine.gosset@aphp.fr; marjolaine.gosset@u-paris.fr",{"name":32,"role":28,"phone":29,"phoneExt":20,"email":33},"Anne Laure Ms BONNET, MCU-PH","anne-laure.bonnet@aphp.fr",[35],{"facility":36,"status":37,"city":38,"state":20,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Carles-Foix Hospital","RECRUITING","Ivry-sur-Seine","94200","France","FR",{"type":43,"coordinates":44},"Point",[45,46],2.38487,48.81568,{"lat":46,"lon":45},[49,51],{"name":23,"role":28,"phone":29,"phoneExt":20,"email":50},"marjolaine.gosset@u-paris.fr; marjolaine.gosset@aphp.fr",{"name":52,"role":28,"phone":29,"phoneExt":20,"email":33},"Anne Laure BONNET, MCU-PH",{"type":54,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100513860","periodontitis-and-inflammation-in-children-with-down-syndrometrisomy-21-study-on-biological-samples-100513860",false,"NCT05970965","Periodontitis and Inflammation in Children With Down Syndrome\u002FTrisomy 21: Study on Biological Samples","Study of Neutrophils During Gingival Inflammation in Children With Down Syndrome\u002FTrisomy 21","NT21","Inclusion Criteria:\n\nCommon to all groups:\n\n* Age: 3 to 12\n* Patient affiliated to a social security program, beneficiary not covered by the AME.\n* Legal representatives who speak and understand French well enough to be able to read and understand the study information.\n* Legal representatives giving written consent for their child's participation in the study.\n\nSpecific:\n\nCase Group:\n\n* Trisomy 21 patient with gingival inflammation (subgroup 1)\n* Trisomy 21 patient with healthy gingiva on intact periodontium with no history of periodontitis (subgroup 2)\n\nControl Group: child meeting one of these criteria:\n\n* Patient with psychomotor retardation with no known repercussions on the orofacial sphere or immunity, presenting gingival inflammation (subgroup 1)\n* 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).\n* Patients with no known general pathology and gingival inflammation (subgroup 3)\n* Patients with no known general pathology and healthy gingiva on intact periodontium with no history of gingival inflammation (subgroup 4)\n\nExclusion Criteria:\n\nCommon to all groups:\n\n* Patient having received antibiotic prophylaxis, antibiotic therapy or anti-inflammatory treatment in the 3 months prior to inclusion\n* Patient included in another interventional research protocol or in a period of exclusion.\n* Patient on AME\n* Patients with a contraindication to the use of MEOPA:\n\n  * Patients requiring pure oxygen ventilation\n  * Intracranial hypertension\n  * Unevaluated head trauma\n  * New-onset, unexplained neurological abnormalities\n  * Pneumothorax\n  * Emphysema bubbles\n  * Gas embolism\n  * Diving accident\n  * Abdominal gas distension, occlusion\n  * Patient recently treated with ophthalmic gas (SF6, C3F8, C2F6)\n  * Known, unsubstituted vitamin B12 deficiency\n\nSpecific to Trisomy 21 group:\n\n\\- Patient with no genetic diagnosis","ALL","3 Years","12 Years",{"count":67,"type":68},18,"ESTIMATED","INTERVENTIONAL",[71],"NA","Since 2018, the Chicago Classification of Periodontal Diseases and Conditions, has listed Down syndrome (DS)\u002Ftrisomy 21 (T21) as a systemic disease with periodontal implications. Numerous studies report an increased prevalence and severity of periodontitis in DS\u002FT21 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\u002FT21 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.\n\nThe investigators hypothesize that specific neutrophil phenotypes in DS\u002FT21 patients are key to explaining the rapid progression to periodontitis.\n\nInvestigator's primary objective is to characterize the different oral and blood neutrophil subtypes in DS\u002FT21 children with gingival inflammation.\n\nInvestigator's secondary objective is to assess the involvement of different neutrophil subtypes in early periodontitis in children with DS\u002FT21.",[74,75],"Periodontitis","Trisomy 21",[77,75,78,79,80,81,82],"Down syndrome","psychomotor retardation","gingivitis","periodontitis","neutrophils","biological collection","2025-05-02",{"date":85,"type":86},"2025-05-06","ACTUAL",{"date":88,"type":86},"2025-04-30",{"date":90,"type":68},"2027-04-30",{"name":5,"class":6},1]