An observational study in Reduction in DMFT Index and Plaque Index in Patients at the Treatment Completion, an Average of 4 Years and DMFT Index, ICDAS Score, Dental Plaque Index, Communication, Prevention, Dentist, Orthodontist, sponsored by CHU de Reims. Recruiting at 1 site in France. Open to participants aged 8 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-07-24.
Sponsored by CHU de Reims · Observational
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.
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:
Individual carious risk (based on HAS-France):
Data collected for study group during each consultation before the orthodontic treatment and followed every 6 months, up to 4 years:
Individual carious risk (based on HAS-France):
314 studies on the registry are indexed under Dental Plaque; 54 are open to participants now.
This study's planned enrollment of 30 is below the median of 60 across 33 observational studies indexed under Dental Plaque.
Browse Dental Plaque studies →CHU de Reims is the lead sponsor of 267 studies on the registry; 50 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients were 8 and 18 years old
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:
Children starting a multi-brackets orthodontic treatment in the oral medicine department of University Hospital of Reims from January 2024. These childrens benefit from semi-annual appointment to analyze their oral health and their individual caries-risk by dentist. Moreover, these results will be communicated with a digital tool to orthodontist who can choose to adapt the orthodontic treatment of these childrens.
Other: There is no intervention
Other: There is no intervention
Observal Study.There is no intervention
Measure of DMFT index
Number of Decayed, Missing due to caries, and Filled Teeth
Time frame: every 6 months, up to 4 years
Measure of plaque index (Silness and Loe)
* Score 0 : absence of microbial plaque * Score 1 : film of bacterial plaque invisible to the naked eye; but thin film of microbial plaque along the free gingival margin collected with a probe * Score 2 : moderate accumulation with plaque in the sulcus visible to naked eye * Score 3 : large amount of plaque visible in sulcus or pocket along the free gingiva margin up to 2mm thick.
Time frame: every 6 months, up to 4 years
Modified Orthodontic Plaque index (MOP)
* Score 0 : no plaque. * Score 1 : accumulation of mesial and/or distal plaque at the base of the attachment. * Score 2 : accumulation of mesial, distal, incisal and/or cervical plaque at the base of the attachment. * Score 3 : continuous plaque accumulation from the marginal gingiva to the base of the attachment. * Score 4 : complete coverage by the plaque.
Time frame: every 6 months, up to 4 years
Measure of ICDAS score
* 0 No evidence of caries * 1 Initial caries * 2 Distinct visual change in enamel * 3 Localised enamel breakdown due to caries with no visible dentine * 4 Underlying dark shadow from dentine * 5 Distinct cavity with visible dentine * 6 Extensive distinct cavity with visible dentine
Time frame: every 6 months, up to 4 years
Socio-Professional Category
* Farmers, * artisans, * traders and business leaders, * executives and higher intellectual professions, * intermediate professions, * employees, * workers
Time frame: Day 1
Communication needed between dentist and orthodontist
focus group of dentist and orthodontist at the beginning and at the end of the study
Time frame: At 48 months
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CHU de Reims