Personalised Prevention of Microbiological Homeostasis in the Oral Cavity During Fixed Orthodontic Treatment (PREPERMIO)

Centre Hospitalier Universitaire de Nice

Status: Not yet enrolling

Conditions: Orthodontics

Treatments: Other: standard care combined with personalised prevention; Other: Standard Care Arm

Study type: Interventional

Funder types: Other

Identifiers

NCT06752902

23-AOI-04

Details and patient eligibility

About

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

Enrollment: 80 estimated patients

Sex: All

Ages: 12 to 20 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

patient with standard care

Other group

Description:

patient with standard care

Treatment:

Other: Standard Care Arm

patient with standard care combined with personalised prevention

Other group

Description:

patient with standard care combined with personalised prevention

Treatment:

Other: standard care combined with personalised prevention