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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06752902
Acronym
PREPERMIO
Enrollment
80
Registered
2024-12-31
Start date
2025-06-01
Completion date
2028-06-06
Last updated
2025-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orthodontics

Keywords

oral dysbiosis, orthodontics, oral microbiotis

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

Interventions

standard care combined with personalised prevention

OTHERstandard care combined with personalised prevention

standard care combined with personalised prevention

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Years to 20 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
viruses in biofilmAt inclusionnumber of viruses measured in the biofilm
bacteria in biofilmAt inclusionnumber of pathogenic bacteria measured in the biofilm

Secondary

MeasureTime frameDescription
plaque indexthrough study completion, an average of 1 yearscale QHI: quigley hein index
patient's satisfactionat 12 monthsPatient satisfaction on a numerical scale from 0 to 10.
toothbrush wearthrough study completion, an average of 1 yeartoothbrush wear with the Toothbrush Wear Index (TWI)
gingival index,through study completion, an average of 1 yeargingival index mesured with Ginigical Index Loe&Silness scale
measurement of immune responseAt inclusionassay of salivary cytokines in ng/ml

Countries

France

Contacts

Primary Contactlaurence LUPI, PUPH
laurence.lupi@univ-cotedazur.fr3392033272

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026