Validation of Dental Malocclusion Schematic Representations for Early Orthodontic Treatment

Dental Malocclusion Clinical Trial

— CHARTE-ODF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03991221
• Other study ID #: APHP180562
• Secondary ID: 2019-A01074-53
• Status: Completed
• Phase: N/A
• Start date: October 21, 2020
• Est. completion date: June 1, 2023

Study information

• Verified date: September 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 659
• Est. completion date: June 1, 2023
• Est. primary completion date: November 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Malocclusion
• Malocclusion

Intervention

Other:
• Dental Exam
Visual examination of the child oral cavity bi non-orthodontist experts and orthodontist expert
• Orthodontics consult
Consultation with an orthodontics specialist if a malocclusion requiring early intervention is detected
• Call back at 6 month
Telephone call back at six months of inclusion in the study if a malocclusion requiring early intervention is detected

Locations

Country	Name	City	State
France	Hôpital de jour pédiatrique - Hôpital Louis Mourier	Colombes
France	Odontologie Pédiatrique - Hôpital Louis Mourier	Colombes
France	Servide d'odontologie - Hôpital Louis Mourier	Colombes
France	Endocrinologie et diabète de l'enfant - Hôpital Bicêtre	Le Kremlin-Bicêtre
France	Neurologie Pédiatrique - Hôpital Bicêtre	Le Kremlin-Bicêtre
France	Cabinet d'odontologie pédiatrique	Montrouge
France	Cabinet privé d'odontologie	Paris
France	Cabinet privé pédiatrique	Paris
France	Cabinet privé pédodontie	Paris
France	Odontologie Pédiatrique - Hôpital Bretonneau	Paris
France	Service d'odontologie - Hôpital Bretonneau	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Detection of each type of malocclusion requiring early orthodontic treatment by non-orthodontist practitioners versus orthodontic experts		2 months
Secondary	Prevalence of malocclusions identified by orthodontic experts		2 months
Secondary	Number of orthodontic consultations within 6 months among children screened for a malocclusion reacquiring early orthodontic treatment		6 months
Secondary	Number of orthodontic treatments started within 6 months among children screened for a malocclusion reacquiring early orthodontic treatment		6 months