Clinical trial NCT06517238: A New Digital Communication Tool Between Dentist and Orthodontist to Improve Dental Prevention
Official title: Development and Evaluation of a New Digital Communication Tool Between Dentists and Orthodontists to Improve Oral Prevention for Patients With Multi-bracket Treatment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Reduction in DMFT Index and Plaque Index in Patients at the Treatment Completion, an Average of 4 Years
DMFT Index, ICDAS Score, Dental Plaque Index, Communication, Prevention, Dentist, Orthodontist
Keywords: Carious lesions
individual caries-risk
plaque index
prevention
communication
dentist
orthodontist
ICDAS
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2024-07-24
Enrollment: 30
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients were 8 and 18 years old

Brief summary: 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.

Detailed 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):

  * Regular brushing
  * Manual or electric brushing
  * Presence of snacking and soda
  * Taking long-term sweet or medication causing hyposialia
  * Presence of dental plaque visualized by dental plaque disclosing tablet
  * Presence of dental plaque visible without dental plaque disclosing tablet
  * Presence of enamel demineralization
  * Presence of caries lesions (dentin involvement) and/or reversible initial lesions (enamel involvement)
  * Serrated grooves in molars
  * Grooves treated by Sealent
  * Fluoride varnish
* 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):

  * Regular brushing
  * Manual or electric brushing
  * Presence of snacking and soda
  * Taking long-term sweet or medication causing hyposialia
  * Presence of dental plaque visualized by dental plaque disclosing tablet
  * Presence of dental plaque visible without dental plaque disclosing tablet
  * Presence of enamel demineralization
  * Presence of caries lesions (dentin involvement) and/or reversible initial lesions (enamel involvement)
  * Serrated grooves in molars
  * Grooves treated by Sealent
  * Fluoride varnish
* Presence of gingival hyperplasia
* Need for prevention and/or care sessions

Eligibility criteria: 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:

* children under 8 years old
* Patients requiring other orthodontic treatment than multi-brackets,
* Patients requiring any orthodontic treatment
* disabled (with a loss of autonomy that don't allow proper brushing)
* dental pathologies like amelogenesis imperfect, dentinogenesis imperfect, ectodermal dysplasia.

Primary outcomes:
measure: Measure of DMFT index
timeFrame: every 6 months, up to 4 years
measure: Measure of plaque index (Silness and Loe)
timeFrame: every 6 months, up to 4 years
measure: Modified Orthodontic Plaque index (MOP)
timeFrame: every 6 months, up to 4 years
measure: Measure of ICDAS score
timeFrame: every 6 months, up to 4 years
measure: Socio-Professional Category
timeFrame: Day 1
Secondary outcomes:
measure: Communication needed between dentist and orthodontist
timeFrame: At 48 months
Other outcomes:
Locations:
city: Reims
country: France
facility: Damien JOLLY
Study officials:
References: