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Dentists and orthodontists of the oral medicine department of Reims University Hospital noted that many children presented white spots around orthodontic brackets, or decays at the end of their multi-brackets orthodontic treatment. These defects required dental cares and sometimes led to dental avulsions. These situations highlighted a poor oral hygiene of children (poorly done or insufficient dental brushing), a lack of oral prevention of their dentist and/or orthodontist, or even a lack of communication between these two practitioners.
The objective of this study is to evaluate if a regular prevention and a specific communication between dentist and orthodontists could reduce the individual caries-risk of patients with multi-brackets orthodontic treatment. During all the orthodontic treatment, a semi-annual oral prevention consultation will be established for each patient, and a digital communication tool will be made available to dentists and orthodontists to facilitate their exchanges.
The study population consists of children under 18 years-old when laying multi-brackets orthodontic treatment.
The study population consists of children aged 8 to 18 years-old (at the start of treatment) treated with multi-brackets orthodontic treatment. The study population is divided in two groups: (i) a control group corresponding to children not benefiting from regular oral preventive follow up monitoring and completing their orthodontic treatment during the year in 2024; (ii) a study group composed of children starting their orthodontic treatment during the year in 2024 and benefiting from regular oral prevention every 6 months, up to four years.
Several parameters will be evaluated from patient medical records: the caries index, the ICDAS score, the plaque index, the oral hygiene and food habits. Concerning the study group, a new digital communication tool will be made available to the dentist and the orthodontist to monitor the oral hygiene of patients. An evaluation of the oral hygiene will be done every 6 months.
The expected outcomes of this study concern the interest of (i) a bi-annual prevention consultation to reduce caries risk, (ii) a regular communication between practitioners to adjust the orthodontic treatment according to the individual caries-risk.
The expected hypothesis is to decrease the patient's caries and plaque indexes in the study group.
Full description
The study population consists of children under 18 years-old when laying multi-brackets orthodontic treatment in the oral medicine department of Reims University Hospital. This population is distributed into 2 groups. The control group consists in children having completed their orthodontic treatment by December 2024, (n=30). The study group consists in children starting their orthodontic treatment during 2024 and benefiting from semi-annual oral prevention during four years-treatment. Moreover, their dentists and orthodontists will be able to access a digital communication tool to facilitate their exchanges. The number of patients in the study group will depend on the number of the patients in the control group.
The study protocol was approved by a regulatory agreement of the RGPD (register of processing activities) of Reims University Hospital since 14/11/23. All data will be anonymized. These data correspond to those that are systematically and usually collected by professionals during the orthodontic treatment. They will be stored in a secure computer located in the oral medicine department. The aim of the study and clinical procedures will be explained to the parents and the children to obtain their informed consent.
Data collected for control group at the treatment completion, an average of 4 years: put out the treatment:
Sex: Girl/Boy/Non-Registered
Date of birth (month/year) / age
Processing end date
Regular orthodontic appointment
Socio-Professional Category (PCS 2020 level 1 nomenclature: 6 levels INSEE) : farmers; artisans, traders and business leaders; executives and higher intellectual professions; intermediate professions ; employees ; workers
Decayed, missing and filled teeth index (DMFT Index)
ICDAS score (International Caries Detection and Assessment System)
Decays under dental restauration
Modified orthodontic plaque index (MOP Index)
Individual carious risk (based on HAS-France):
Presence of gingival hyperplasia
Data collected for study group during each consultation before the orthodontic treatment and followed every 6 months, up to 4 years:
Appointment date
Sex: Girl/Boy/Non-Registered
Date of birth (month/year) / age
Regular follow-up with a dentist
Socio-Professional Category (PCS 2020 level 1 nomenclature: 6 levels INSEE) : farmers; artisans, traders and business leaders; executives and higher intellectual professions; intermediate professions ; employees ; workers
Decayed, missing and filled teeth index (DMFT Index)
ICDAS score (International Caries Detection and Assessment System)
Plaque Index Silness et Loe before treatment
Modified orthodontic plaque index (MOP Index) as soon as the treatment is applied
Molar Incisor Hypomineralization (MIH): degree of severity (moderate - severe), type of teeth affected (molars - incisors), number of teeth treated
Amelar abnormality: incisal dysplasia, number of teeth treated
Individual carious risk (based on HAS-France):
Presence of gingival hyperplasia
Need for prevention and/or care sessions
Enrollment
Sex
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Volunteers
Inclusion criteria
Patients aged under 18 years old when laying treatment. They required multi-brackets orthodontic treatment in the oral medicine department of the Reims University Hospital
Exclusion criteria
30 participants in 2 patient groups
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Central trial contact
Charline GUIDEZ
Data sourced from clinicaltrials.gov
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