Validation of Dental Malocclusion Schematic Representations for Early Orthodontic Treatment (CHARTE-ODF)

Validation of Schematic Representations for Dental Malocclusion and Craniofacial Deformities Screening in Temporary and Mixed Dentition Requiring Early Orthodontic Treatment

Dental occlusion is the reciprocal confrontation of the two dental arches. The child has two set of temporary and permanent teeth and passes through different stages of dentition during which dental, skeletal or functional abnormalities may appear.

Dental malocclusion is defined as an incorrect position of the teeth in the bone base, as well as the incoordination of the teeth of the opposite arches or the displacement of the maxillary and mandibular skeletal bases.

When a malocclusion is detected during clinical examination, patients are referred to an orthodontic specialist. The interception in orthodontics is carried out during a growing period; it consists of correcting or reducing malocclusions in evolution and eliminating the functional causes to prevent aggravation of skeletal and dental abnormalities.

An epidemiological study conducted in France on 789 children showed that 37.4% had at least one type of dental malocclusion. In 2010, a study of 5988 French children showed that 14% of them had received orthodontic treatment. These studies reveal a discrepancy between treatment needs and treatments conducted. In addition, certain dental malocclusions and skeletal disorders, such as lateral and anterior crossbite, require early orthodontic treatment in order to avoid aggravation of the occlusion disorder and induction of craniofacial growth disorders. Unfortunately these discrepancies are not always detected by the caregivers (pediatrician, general dentist, pediatric dentist).

A schematic representation of malocclusions in temporary and mixed dentition requiring orthodontic interception has been developed by the investigator's team to provide a simple visual means of identifying these dental and skeletal disorders in order to improve early screening by practitioners involved in the mandatory medical follow-up of children.

Study Overview

• Status: Completed
• Conditions: Dental Malocclusion
• Intervention / Treatment: Other: Dental Exam; Other: Orthodontics consult; Other: Call back at 6 month

Detailed Description

Dental malocclusion is defined as an incorrect position of the teeth in the bone base, as well as the incoordination of the teeth of the opposite arches or the displacement of the maxillary and mandibular skeletal bases.

When a malocclusion is detected during clinical examination, patients are referred to an orthodontic specialist. The interception in orthodontics is carried out during a growing period; it consists of correcting or reducing malocclusions in evolution and eliminating the functional causes to prevent aggravation of skeletal and dental abnormalities. Early intervention is critical for specific dental malocclusions and skeletal disorders, such as lateral and anterior crossbite in order to avoid aggravation of the occlusion disorder and induction of craniofacial growth disorders. Unfortunately these discrepancies are not always detected by the caregivers (pediatrician, general dentist, pediatric dentist).

• Study Type: Interventional
• Enrollment (Actual): 659
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ELVIRE LE NORCY, DDS; Phone Number: 33 0762965050; Email: elvire.lenorcy@aphp.fr
• Study Contact Backup: Name: Aline DECHANET; Phone Number: 0140257830; Email: aline.dechanet@aphp.fr

Study Locations

• France
  • Colombes, France, 92700
    • Hôpital de jour pédiatrique - Hôpital Louis Mourier
  • Colombes, France, 92700
    • Odontologie Pédiatrique - Hôpital Louis Mourier
  • Colombes, France, 92700
    • Servide d'odontologie - Hôpital Louis Mourier
  • Le Kremlin-Bicêtre, France, 94270
    • Endocrinologie et diabète de l'enfant - Hôpital Bicêtre
  • Le Kremlin-Bicêtre, France, 94270
    • Neurologie Pédiatrique - Hôpital Bicêtre
  • Montrouge, France, 92120
    • Cabinet d'odontologie pédiatrique
  • Paris, France, 75009
    • Cabinet privé pédiatrique
  • Paris, France, 75014
    • Cabinet privé pédodontie
  • Paris, France, 75018
    • Odontologie Pédiatrique - Hôpital Bretonneau
  • Paris, France, 75018
    • Service d'odontologie - Hôpital Bretonneau
  • Paris, France, Paris
    • Cabinet privé d'odontologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 10 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• child between 5 and 10 years old
• seen in consultation with pediatrician, pediatric dentist, or general dentist,

Exclusion Criteria:

• child not letting himself be examined,
• children who have already received orthodontic treatment and / or are currently undergoing orthodontic treatment
• Absence of free and informed consent
• Non affiliation to a social security regime or CMU

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Dental exam by orthodontic non-specialists; Detection of the presence of at least one malocclusion by orthodontic non-specialists with the graphic chart	Other: Dental Exam; Visual examination of the child oral cavity bi non-orthodontist experts and orthodontist expert
Other: Dental exam by orthodontic experts; Detection of the presence of at least one malocclusion by orthodontic experts	Other: Dental Exam; Visual examination of the child oral cavity bi non-orthodontist experts and orthodontist expert; Other: Orthodontics consult; Consultation with an orthodontics specialist if a malocclusion requiring early intervention is detected; Other: Call back at 6 month; Telephone call back at six months of inclusion in the study if a malocclusion requiring early intervention is detected

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection the presence of at least one malocclusion in children, requiring an early orthodontic treatment, compared to orthodontic experts (gold-standard)	Study of the performance of orthodontic non-specialists with the graphic chart to detect the presence of at least one malocclusion in children, requiring an early orthodontic treatment, compared to orthodontic experts (gold-standard)	2 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Detection of each type of malocclusion requiring early orthodontic treatment by non-orthodontist practitioners versus orthodontic experts	2 months
Prevalence of malocclusions identified by orthodontic experts	2 months
Number of orthodontic consultations within 6 months among children screened for a malocclusion reacquiring early orthodontic treatment	6 months
Number of orthodontic treatments started within 6 months among children screened for a malocclusion reacquiring early orthodontic treatment	6 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2020
• Primary Completion (Actual): November 5, 2022
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: May 24, 2019
• First Submitted That Met QC Criteria: June 18, 2019
• First Posted (Actual): June 19, 2019

Study Record Updates

• Last Update Posted (Actual): September 5, 2023
• Last Update Submitted That Met QC Criteria: September 1, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Prevention; Malocclusion; Early treatment; Skeletal discrepancy
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion
• Other Study ID Numbers: APHP180562; 2019-A01074-53 (Other Identifier: IDRCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No