• A New Digital Communication Tool Between Dentist and Orthodontist to Improve Dental Prevention

  NCT06517238

  RecruitingObservationalUpdated Jul 24, 2024
• Evaluation of the Effect of a Probiotic in Patients Undergoing Orthodontic Therapy

  NCT06752330

  CompletedInterventionalNot ApplicableUpdated Oct 1, 2025
• Using Probiotics to Improve Oral Hygiene During Orthodontic Treatment

  NCT06641960

  CompletedInterventionalNot ApplicableUpdated Oct 16, 2024
• Effect of Probiotics on the Periodontal Status of Orthodontic Patients

  NCT04634201

  TerminatedInterventionalNot ApplicableUpdated May 22, 2026
• Influence of Probiotics on Clinical Parameters, the Oral Microbiome and the Immune System During an Orthodontic Treatment

  NCT04598633

  Unknown statusInterventionalNot ApplicableUpdated May 18, 2022
• The Effect of Oral Probiotics on Oral Hygiene and Halitosis in Orthodontic Patients.

  NCT05651503

  CompletedInterventionalNot ApplicableUpdated Dec 10, 2025

ClinicalTrials.gov ID

NCT06752902

Lead Sponsor

Centre Hospitalier Universitaire de NiceOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

80Estimated

Last Update Posted

May 23, 2025Actual

Start Date

Jun 1, 2025Estimated

Primary Completion Date

May 1, 2027Estimated

Completion Date

Jun 6, 2028Estimated

Official Title

Impact of a Personalised Prevention Approach on the Microbiological Homeostasis of the Oral Cavity During Fixed Orthodontic Treatment: Randomised Interventional Study

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

• Orthodontics

• Standard Care Arm
• standard care combined with personalised prevention

Ages Eligible for Study

Child (0-17)Adult (18-64)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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 Purpose

Other

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Centre Hospitalier Universitaire de NiceOTHER

laurence.lupi@univ-cotedazur.fr+33492033270