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

ConditionOrthodontics
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-20
SponsorCentre Hospitalier Universitaire de Nice

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Tobacco;

Overcrowded restorations, untreated caries,

lack of tooth mineralisation;

Medical pathologies;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standard Care Arm

    Other intervention

    standard care combined with personalised prevention

  • standard care combined with personalised prevention

    Other intervention

    standard care combined with personalised prevention

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: patient with standard careOther 1 intervention
Group B: patient with standard care combined with personalised preventionOther 1 intervention

Trial outcomes

Primary outcomes

1

bacteria in biofilm

number of pathogenic bacteria measured in the biofilm

Time frame
At inclusion
2

bacteria in biofilm

number of pathogenic bacteria measured in the biofilm

Time frame
At 3 months
3

bacteria in biofilm

number of pathogenic bacteria measured in the biofilm

Time frame
At 6 months
4

bacteria in biofilm

number of pathogenic bacteria measured in the biofilm

Time frame
At 9 months

Secondary outcomes

1

patient's satisfaction

Patient satisfaction on a numerical scale from 0 to 10.

Time frame
at 12 months
2

measurement of immune response

assay of salivary cytokines in ng/ml

Time frame
At inclusion
3

measurement of immune response

assay of salivary cytokines in ng/ml

Time frame
At 3 months
4

measurement of immune response

assay of salivary cytokines in ng/ml

Time frame
At 6 months

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: