Clinical trial NCT06752902: Personalised Prevention of Microbiological Homeostasis in the Oral Cavity During Fixed Orthodontic Treatment
Official title: Impact of a Personalised Prevention Approach on the Microbiological Homeostasis of the Oral Cavity During Fixed Orthodontic Treatment: Randomised Interventional Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Orthodontics
Keywords: oral dysbiosis
orthodontics
oral microbiotis
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2024-12-31
Enrollment: 80
Sex: ALL
Minimum age (years): 12
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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: 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

Primary outcomes:
measure: bacteria in biofilm
timeFrame: At inclusion
measure: bacteria in biofilm
timeFrame: At 3 months
measure: bacteria in biofilm
timeFrame: At 6 months
measure: bacteria in biofilm
timeFrame: At 9 months
measure: bacteria in biofilm
timeFrame: At 12 months
measure: viruses in biofilm
timeFrame: At inclusion
measure: viruses in biofilm
timeFrame: At 3 months
measure: viruses in biofilm
timeFrame: At 6 months
measure: viruses in biofilm
timeFrame: At 9 months
measure: viruses in biofilm
timeFrame: At 12 months
Secondary outcomes:
measure: patient's satisfaction
timeFrame: at 12 months
measure: measurement of immune response
timeFrame: At inclusion
measure: measurement of immune response
timeFrame: At 3 months
measure: measurement of immune response
timeFrame: At 6 months
measure: measurement of immune response
timeFrame: At 9 months
measure: measurement of immune response
timeFrame: At 12 months
measure: plaque index
timeFrame: through study completion, an average of 1 year
measure: gingival index,
timeFrame: through study completion, an average of 1 year
measure: toothbrush wear
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Dinan
country: France
facility: Rance Orthodontics Practice
city: Nice
country: France
facility: Nice university hospital
Study officials:
References: