BridgeMD
New treatment option for Periodontitis
Official title Periodontitis and Inflammation in Children With Down Syndrome/Trisomy 21: Study on Biological Samples
ClinicalTrials.gov ID: NCT05970965
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 12
You may be able to join if
- 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:
You likely can't join if
- 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 treatment 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
See the full eligibility 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)
- 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 treatment 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
The study team makes the final eligibility decision.
Where it's taking place
- Ivry-sur-Seine, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 years to 12 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ivry-sur-Seine, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.