Personalised Prevention of Microbiological Homeostasis in the Oral Cavity During Fixed Orthodontic Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standard Care Arm, standard care combined with personalised prevention.
- Who it may be relevant to
- Registry conditions: Orthodontics. Basic parameters: 12 years — 20 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Impact of a Personalised Prevention Approach on the Microbiological Homeostasis of the Oral Cavity During Fixed Orthodontic Treatment: Randomised Interventional Study
Overview
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
Interventions
- Other Standard Care Arm
standard care combined with personalised prevention - Other standard care combined with personalised prevention
standard care combined with personalised prevention
Primary outcome measures
- bacteria in biofilm [Time frame: At inclusion]
- bacteria in biofilm [Time frame: At 3 months]
- bacteria in biofilm [Time frame: At 6 months]
- bacteria in biofilm [Time frame: At 9 months]
- bacteria in biofilm [Time frame: At 12 months]
- viruses in biofilm [Time frame: At inclusion]
- viruses in biofilm [Time frame: At 3 months]
- viruses in biofilm [Time frame: At 6 months]
- viruses in biofilm [Time frame: At 9 months]
- viruses in biofilm [Time frame: At 12 months]
Secondary outcome measures (9)
- patient's satisfaction [Time frame: at 12 months]
- measurement of immune response [Time frame: At inclusion]
- measurement of immune response [Time frame: At 3 months]
- measurement of immune response [Time frame: At 6 months]
- measurement of immune response [Time frame: At 9 months]
- measurement of immune response [Time frame: At 12 months]
- plaque index [Time frame: through study completion, an average of 1 year]
- gingival index, [Time frame: through study completion, an average of 1 year]
- toothbrush wear [Time frame: through study completion, an average of 1 year]
Eligibility criteria
Inclusion criteria
- Patients aged 12 to 20 (permanent dentition) requiring fixed orthodontic treatment.
Exclusion criteria
- Tobacco;
- Overcrowded restorations, untreated caries,
- lack of tooth mineralisation;
- Medical pathologies;
- Known immunodepression (congenital or acquired);
- Taking a treatment that may induce general immunodepression;
- Taking a probiotic;
- Taking a concomitant treatment that may interact with oral health
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 2 centers
- Rance Orthodontics Practice — Dinan
- Nice university hospital — Nice
Identifiers
NCT: NCT06752902 · 23-AOI-04