PeriodontitisNT21NCT05970965
Periodontitis and Inflammation in Children With Down Syndrome/Trisomy 21: Study on Biological Samples
A study testing Biological sampling in people with Periodontitis and Trisomy 21, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Periodontitis, Trisomy 21
- What is being tested?
- Biological sampling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- 30 Apr 2025to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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:
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- 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)
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Marjolaine Ms GOSSET, PU-PH contact
France1 site, 1 recruiting
- Recruiting
Carles-Foix Hospital
Ivry-sur-Seine, 94200
Marjolaine Ms GOSSET, PU-PH, 0149594811, marjolaine.gosset@u-paris.fr; marjolaine.gosset@aphp.fr
Anne Laure BONNET, MCU-PH, 0149594811, anne-laure.bonnet@aphp.fr
About this study
Official title: Study of Neutrophils During Gingival Inflammation in Children With Down Syndrome/Trisomy 21
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.
Read more
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.
Read the 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 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:
- Primary criteria: Neutrophil subtypes analysis based on co-expression of neutrophil function markers from a panel of 24 markers by flow cytometry.
- Secondary criteria: assessment of neutrophil sub-types present in the patient's saliva and study of the correlation within blood neutrophils, during periodontal health, gingivitis and periodontitis.
- Conditions
- Periodontitis, Trisomy 21
- Being tested
- Biological sampling
- Keywords
- Down syndrome, Trisomy 21, psychomotor retardation, gingivitis, periodontitis, neutrophils, biological collection
- Medical subject headings
- Periodontitis, Down Syndrome, Psychomotor Disorders, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological samplingProcedure or surgery
- Saliva and blood sampling
| Study group | Role | What they receive |
|---|---|---|
| Child patient consulting the service | Experimental | * 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) Receives: Procedure: Biological sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (1)
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start30 Apr 2025
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marjolaine Ms GOSSET, PU-PH, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05970965
- Sponsor's protocol ID
- APHP230786
- Acronym
- NT21
- Status last verified
- May 2025
- First submitted
- 24 Jul 2023
- Last updated
- 6 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Neutrophils During Gingival Inflammation in Children With Down Syndrome/Trisomy 21
- ClinicalTrials.gov ID
- NCT05970965
- Acronym / sponsor ID
- NT21 / APHP230786
- Conditions
- Periodontitis, Trisomy 21
- Keywords
- Down syndrome, Trisomy 21, psychomotor retardation, gingivitis, periodontitis, neutrophils, biological collection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 30 Apr 2025 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 2 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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:
- Primary criteria: Neutrophil subtypes analysis based on co-expression of neutrophil function markers from a panel of 24 markers by flow cytometry.
- Secondary criteria: assessment of neutrophil sub-types present in the patient's saliva and study of the correlation within blood neutrophils, during periodontal health, gingivitis and periodontitis.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Child patient consulting the service | Experimental | Procedure: Biological sampling* 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) |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (14 listed)
- 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.
- Trisomy 21 patient with gingival inflammation (subgroup 1)
Key exclusion criteria (18 listed)
- 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:
- Patient with no genetic diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological sampling- Saliva and blood sampling | Procedure or surgery | Child patient consulting the service |
Primary outcome
Distinction of neutrophil subtypes according to co-expression of markers of neutrophil function among a panel of 24 markers by flow cytometry
Time frame: 1 year
purification od neutrophils from blood and saliva Fixation Cell sorting using FACS on a panel of 24 markers
1 secondary outcome
Evaluation of neutrophil subtypes present in saliva and study of a correlation with blood neutrophils during periodontal health and periodontal inflammation (intra individual analysis)
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marjolaine Ms GOSSET, PU-PH contact
Marjolaine Ms GOSSET, PU-PH principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biological sampling in people with Periodontitis and Trisomy 21, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marjolaine Ms GOSSET, PU-PH (0149594811, marjolaine.gosset@aphp.fr; marjolaine.gosset@u-paris.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distinction of neutrophil subtypes according to co-expression of markers of neutrophil function among a panel of 24 markers by flow cytometry (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2025.