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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Orthodontics
• Intervention / Treatment: Other: Standard Care Arm; Other: standard care combined with personalised prevention

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: laurence LUPI, PUPH; Phone Number: 3392033272; Email: laurence.lupi@univ-cotedazur.fr

Study Locations

• France
  • Dinan, France, 22100
    • Rance Orthodontics Practice
    • Contact: Olivier Sorel
    • Sub-Investigator: olivier SOREL
  • Nice, France, 06000
    • Nice University Hospital
    • Contact: Laurence LUPI, PUPH; Phone Number: +33492033270; Email: laurence.lupi@univ-cotedazur.fr
    • Principal Investigator: laurence LUPI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: patient with standard care	Other: Standard Care Arm; standard care combined with personalised prevention
Other: patient with standard care combined with personalised prevention	Other: standard care combined with personalised prevention; standard care combined with personalised prevention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
bacteria in biofilm	number of pathogenic bacteria measured in the biofilm	At inclusion
bacteria in biofilm	number of pathogenic bacteria measured in the biofilm	At 3 months
bacteria in biofilm	number of pathogenic bacteria measured in the biofilm	At 6 months
bacteria in biofilm	number of pathogenic bacteria measured in the biofilm	At 9 months
bacteria in biofilm	number of pathogenic bacteria measured in the biofilm	At 12 months
viruses in biofilm	number of viruses measured in the biofilm	At inclusion
viruses in biofilm	number of viruses measured in the biofilm	At 3 months
viruses in biofilm	number of viruses measured in the biofilm	At 6 months
viruses in biofilm	number of viruses measured in the biofilm	At 9 months
viruses in biofilm	number of viruses measured in the biofilm	At 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient's satisfaction	Patient satisfaction on a numerical scale from 0 to 10.	at 12 months
measurement of immune response	assay of salivary cytokines in ng/ml	At inclusion
measurement of immune response	assay of salivary cytokines in ng/ml	At 3 months
measurement of immune response	assay of salivary cytokines in ng/ml	At 6 months
measurement of immune response	assay of salivary cytokines in ng/ml	At 9 months
measurement of immune response	assay of salivary cytokines in ng/ml	At 12 months
plaque index	scale QHI: quigley hein index	through study completion, an average of 1 year
gingival index,	gingival index mesured with Ginigical Index Loe&Silness scale	through study completion, an average of 1 year
toothbrush wear	toothbrush wear with the Toothbrush Wear Index (TWI)	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): June 6, 2028

Study Registration Dates

• First Submitted: October 11, 2024
• First Submitted That Met QC Criteria: December 20, 2024
• First Posted (Actual): December 31, 2024

Study Record Updates

• Last Update Posted (Actual): May 23, 2025
• Last Update Submitted That Met QC Criteria: May 20, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: orthodontics; oral dysbiosis; oral microbiotis
• Other Study ID Numbers: 23-AOI-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No