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

NCT06752902 | Not Yet Recruiting

• 1 other identifier: 23-AOI-04
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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

Conditions

Orthodontics

Keywords

oral dysbiosis; orthodontics; oral microbiotis

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (9)

• patient's satisfaction

  at 12 months

• measurement of immune response

  At inclusion

• measurement of immune response

  At 3 months

• measurement of immune response

  At 6 months

• measurement of immune response

  At 9 months

Study Arms (2)

patient with standard care

OTHER

patient with standard care

Other: Standard Care Arm

patient with standard care combined with personalised prevention

OTHER

patient with standard care combined with personalised prevention

Other: standard care combined with personalised prevention

Interventions

Standard Care Arm OTHER

standard care combined with personalised prevention

patient with standard care

standard care combined with personalised prevention OTHER

standard care combined with personalised prevention

patient with standard care combined with personalised prevention

Eligibility Criteria

• Age: 12 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients aged 12 to 20 (permanent dentition) requiring fixed orthodontic treatment.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (2)

Rance Orthodontics Practice

Dinan, 22100, France

Location

Nice university hospital

Nice, 06000, France

Location

Central Study Contacts

laurence LUPI, PUPH

CONTACT

3392033272; laurence.lupi@univ-cotedazur.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: December 31, 2024
• Study Start: June 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): June 6, 2028
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)