Clinical trial Recruiting at 1 site Interventional Ages 3 to 12

Investigating Periodontitis in Children with Down Syndrome

Official title: Study of Neutrophils During Gingival Inflammation in Children With Down Syndrome/Trisomy 21

Run by Assistance Publique - Hôpitaux de Paris · NCT05970965 · Data updated 2026-11-12

This study is trying to see how gum disease affects children with Down syndrome by looking at their immune response and comparing it to children with similar developmental challenges.

Quick facts

Study typeInterventional
Ages3 Years to 12 Years
SexAll
Enrollment18 (estimated)
SponsorAssistance Publique - Hôpitaux de Paris
Academic / other
Locations1 site (Ivry-sur-Seine)
StatusRecruiting
StartedApril 30, 2025
Main results expectedApril 30, 2027
Study endsApril 30, 2027
Registry record updatedMay 6, 2025
Trial IDNCT05970965 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are children aged 3 to 12 with Down syndrome and varying periodontal health statuses.

Probably not a fit

Patients with conditions unrelated to Down syndrome or those outside the specified age range may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to explore the relationship between periodontitis and immune response in children with Down syndrome (trisomy 21). It will collect saliva and serum samples from participants to analyze different neutrophil subtypes associated with gingival inflammation. The study will involve two groups: children with Down syndrome and a control group of children with psychomotor retardation. The primary focus is on understanding how specific neutrophil phenotypes may contribute to the progression of periodontitis in these patients.

Why it matters

Potential benefit: If successful, this research could lead to better understanding and management of periodontal disease in children with Down syndrome.

How similar studies have gone: While studies have explored periodontitis in various populations, this specific focus on Down syndrome and neutrophil phenotypes is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
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 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

Where it's running

  • Carles-Foix Hospital
    Ivry-sur-Seine, France
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.