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

Not Applicable

Not yet recruiting

• Conditions: Orthodontics

• Registration Number: NCT06752902
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-11
• Study First Submitted QC: 2024-12-20
• Study First Posted: 2024-12-31
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-23
• Study Start: 2025-06-01
• Primary Completion: 2027-05-01
• Study Completion: 2028-06-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
bacteria in biofilm	At 12 months	number of pathogenic bacteria measured in the biofilm
viruses in biofilm	At 12 months	number of viruses measured in the biofilm

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Rance Orthodontics Practice; 🇫🇷 Dinan, France

Nice university hospital; 🇫🇷 Nice, France