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

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Recruiting
CT.gov ID
NCT03991221
Collaborator
(none)
1,000
11
2
31.4
90.9
2.9

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Dental Exam
  • Other: Orthodontics consult
  • Other: Call back at 6 month
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
1000 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Validation of Schematic Representations for Dental Malocclusion and Craniofacial Deformities Screening in Temporary and Mixed Dentition Requiring Early Orthodontic Treatment
Actual Study Start Date :
Oct 21, 2020
Anticipated Primary Completion Date :
Nov 5, 2022
Anticipated Study Completion Date :
Jun 5, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Detection the presence of at least one malocclusion in children, requiring an early orthodontic treatment, compared to orthodontic experts (gold-standard) [2 months]

    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)

Secondary Outcome Measures

  1. Detection of each type of malocclusion requiring early orthodontic treatment by non-orthodontist practitioners versus orthodontic experts [2 months]

  2. Prevalence of malocclusions identified by orthodontic experts [2 months]

  3. Number of orthodontic consultations within 6 months among children screened for a malocclusion reacquiring early orthodontic treatment [6 months]

  4. Number of orthodontic treatments started within 6 months among children screened for a malocclusion reacquiring early orthodontic treatment [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 10 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hôpital de jour pédiatrique - Hôpital Louis Mourier Colombes France 92700
2 Odontologie Pédiatrique - Hôpital Louis Mourier Colombes France 92700
3 Servide d'odontologie - Hôpital Louis Mourier Colombes France 92700
4 Endocrinologie et diabète de l'enfant - Hôpital Bicêtre Le Kremlin-Bicêtre France 94270
5 Neurologie Pédiatrique - Hôpital Bicêtre Le Kremlin-Bicêtre France 94270
6 Cabinet d'odontologie pédiatrique Montrouge France 92120
7 Cabinet privé pédiatrique Paris France 75009
8 Cabinet privé pédodontie Paris France 75014
9 Odontologie Pédiatrique - Hôpital Bretonneau Paris France 75018
10 Service d'odontologie - Hôpital Bretonneau Paris France 75018
11 Cabinet privé d'odontologie Paris France Paris

Sponsors and Collaborators

  • Assistance Publique - Hôpitaux de Paris

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT03991221
Other Study ID Numbers:
  • APHP180562
  • 2019-A01074-53
First Posted:
Jun 19, 2019
Last Update Posted:
Mar 22, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Assistance Publique - Hôpitaux de Paris
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 22, 2022