An interventional study of Biological sampling in Periodontitis and Trisomy 21, sponsored by Assistance Publique - Hôpitaux de Paris. Recruiting at 1 site in France. Open to participants aged 3 Years to 12 Years. Per ClinicalTrials.gov, last updated 2025-05-06.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Basic science
Among 31 studies in Periodontitis with a site in France — 13 open to participants now, 13 under way, none of them phase 3. Periodontitis · France.
Among the 31 studies in Periodontitis with a site in France, this one is the 17th largest by planned enrollment of the 19 interventional ones that give a count, is one of 3 that started in 2025, is one of 17 with no phase, reaches primary completion later than 5 of the 12 other live ones, and was the 25th registered.
1,231 studies on the registry are indexed under Periodontitis; 295 are open to participants now.
Browse Periodontitis studies →13 of the 31 studies in Periodontitis with a site in France are open now. Recruiting first, the newest first:
University Hospital, Clermont-Ferrand · Sites in France
University Hospital, Clermont-Ferrand · Sites in France
Assistance Publique - Hôpitaux de Paris · Sites in France
Recherche Clinique en Odontologie (ReCOL) · Sites in France, Réunion
CHU de Reims · Sites in France
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 158 Periodontitis studies recruiting now, 78 (49%) set no upper age limit and 60 (38%) stop at 75 or younger; 12 take children under 18; 76 take healthy volunteers.
This study: 3 Years to 12 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
31 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 3 started in 2025.
This study's planned enrollment of 18 is below the median of 44 across 846 interventional studies indexed under Periodontitis.
Median enrollment 49 across the 19 interventional studies, 97 across the 12 observational. Of the 12 that completed or were terminated, 1 (8%) have results posted.
This tab as a report to print or save as PDF → With an account.
2 of 31 have an industry lead sponsor. The 10 most frequent:
Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
Assistance Publique - Hôpitaux de Paris has 5 studies filed under Periodontitis — fewer than ten, so there is no comparison to draw.
4 of the studies in Periodontitis with a site in France that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07205588Recherche Clinique en Odontologie (ReCOL)Assessment of Dental Pathologies Using Digital Tools | 2026-12-31 |
| NCT05970965Assistance Publique - Hôpitaux de ParisPeriodontitis and Inflammation in Children With Down Syndrome/Trisomy 21: Study on Biological Samples | 2027-04-30 |
| NCT07868042University Hospital, Clermont-FerrandEvaluation of Changes in Oral Health-related Quality of Life During the Treatment of Periodontitis. | 2027-09-01 |
| NCT07665489University Hospital, Clermont-FerrandEvaluation of Masticatory Performance in Patients With Periodontitis | 2027-10-09 |
Among the 31 studies in Periodontitis with a site in France, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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 form a biological collection.
Patients will be recruited in the oral medicine department of AP-HP Charles Foix hospital (Ivry/Seine) by periodontists in 2 groups (CASES: Group 1 for children with DS/T21 divided into 2 subgroups according the periodontal health, and CONTROLS: Group 2 divided into 4 subgroups according to the systemic and periodontal health) Inclusion period is 12 months. There is no specific follow-up due to the research.
Assessment criteria:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Common to all groups:
Specific:
Case Group:
Control Group: child meeting one of these criteria:
Exclusion Criteria:
Common to all groups:
Patients with a to the use of MEOPA:
Specific to Trisomy 21 group:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
* Trisomy 21 patient with gingival inflammation (subgroup 1) * Trisomy 21 patient with healthy gingiva on intact periodontium with no history of periodontitis (subgroup 2) * 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)
Procedure: Biological sampling
- Saliva and blood sampling
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 year
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 year
Plan to share: Yes — Data are available upon reasonable request : The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
Access criteria: Researchers who provide a methodologically sound proposal.
No publications or documents are linked to this record.
Started Apr 2025 (actual). Primary completion is estimated for Apr 2027, 24 months after the start.
Of 480 non-industry interventional studies with no phase under Periodontitis, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 31. This study's planned 24 months is above that.
Counting every sponsor, half of 494 studies reached it within 16 months; a quarter within 8 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
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