About this trial
Oral dysbiosis systematically develops during orthodontic treatment \[35\]\[36\]. Orthodontic appliances interfere with oral hygiene procedures and cause biofilm to accumulate, creating new retention zones, even in subjects who maintain correct oral hygiene \[37\]:
* A group benefiting from intensive personalised prevention * A "conventionally monitored" group, with no personalised prevention. The hypothesis is that personalised prevention prevents dysbiosis from taking hold. If this hypothesis is confirmed, the concept could be extended to all patients, beyond orthodontics.
Based on the "biological signature" (microbiological and immune), a "risk profile" of patients could be defined, making it possible to better personalise the prevention message, the method applied and the frequency of follow-up. The aim would be to rebalance dysbiosis through a personalised prevention approach tailored to the profile defined.
It was decided to explore this hypothesis initially with orthodontic patients because they are "captive", i.e. in the course of treatment requiring regular visits. Prevention is aimed first and foremost at healthy patients, with the aim of maintaining them in good health. The project focuses on young patients undergoing orthodontic treatment
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 12 to 20 (permanent dentition) requiring fixed orthodontic treatment.
Disqualifiers
Tobacco;
Overcrowded restorations, untreated caries,
lack of tooth mineralisation;
Medical pathologies;
Trial design
Parallel
Treatments tested in this trial
Standard Care Arm
Other interventionstandard care combined with personalised prevention
standard care combined with personalised prevention
Other interventionstandard care combined with personalised prevention
Treatment groups
Trial outcomes
Primary outcomes
bacteria in biofilm
number of pathogenic bacteria measured in the biofilm
bacteria in biofilm
number of pathogenic bacteria measured in the biofilm
bacteria in biofilm
number of pathogenic bacteria measured in the biofilm
bacteria in biofilm
number of pathogenic bacteria measured in the biofilm
Secondary outcomes
patient's satisfaction
Patient satisfaction on a numerical scale from 0 to 10.
measurement of immune response
assay of salivary cytokines in ng/ml
measurement of immune response
assay of salivary cytokines in ng/ml
measurement of immune response
assay of salivary cytokines in ng/ml
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: