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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-01

Study Completion Date

2028-06-06

Brief Summary

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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

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Detailed Description

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Conditions

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Orthodontics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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patient with standard care

Group Type OTHER

Standard Care Arm

Intervention Type OTHER

standard care combined with personalised prevention

patient with standard care combined with personalised prevention

Group Type OTHER

standard care combined with personalised prevention

Intervention Type OTHER

standard care combined with personalised prevention

Interventions

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Standard Care Arm

standard care combined with personalised prevention

Intervention Type OTHER

standard care combined with personalised prevention

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No