Standard Care Arm
Otherstandard care combined with personalised prevention
NCT Number: NCT06752902
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
Trial opening soon.
Get Notified12 year–20 year
All sexes
Interventional
Not applicable
Rance Orthodontics Practice, Dinan, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
standard care combined with personalised prevention
standard care combined with personalised prevention
Time frame: At inclusion
number of pathogenic bacteria measured in the biofilm
Time frame: At 3 months
number of pathogenic bacteria measured in the biofilm
Time frame: At 6 months
number of pathogenic bacteria measured in the biofilm
Time frame: At 9 months
number of pathogenic bacteria measured in the biofilm
Time frame: At 12 months
number of pathogenic bacteria measured in the biofilm
Time frame: At inclusion
number of viruses measured in the biofilm
Time frame: At 3 months
number of viruses measured in the biofilm
Time frame: At 6 months
number of viruses measured in the biofilm
Time frame: At 9 months
number of viruses measured in the biofilm
Time frame: At 12 months
number of viruses measured in the biofilm
Time frame: at 12 months
Patient satisfaction on a numerical scale from 0 to 10.
Time frame: At inclusion
assay of salivary cytokines in ng/ml
Time frame: At 3 months
assay of salivary cytokines in ng/ml
Time frame: At 6 months
assay of salivary cytokines in ng/ml
Time frame: At 9 months
assay of salivary cytokines in ng/ml
Time frame: At 12 months
assay of salivary cytokines in ng/ml
Time frame: through study completion, an average of 1 year
scale QHI: quigley hein index
Time frame: through study completion, an average of 1 year
gingival index mesured with Ginigical Index Loe&Silness scale
Time frame: through study completion, an average of 1 year
toothbrush wear with the Toothbrush Wear Index (TWI)
Contact information is provided by the study sponsor or research team.
Centre Hospitalier Universitaire de Nice
Other
Impact of a Personalised Prevention Approach on the Microbiological Homeostasis of the Oral Cavity During Fixed Orthodontic Treatment: Randomised Interventional Study
Acronym: PREPERMIO
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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