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
2 other identifiers
interventional
659
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2020
Typical duration for not_applicable
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2019
CompletedFirst Posted
Study publicly available on registry
June 19, 2019
CompletedStudy Start
First participant enrolled
October 21, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 5, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedSeptember 5, 2023
September 1, 2023
2 years
May 24, 2019
September 1, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
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
Study Arms (2)
Dental exam by orthodontic non-specialists
OTHERDetection of the presence of at least one malocclusion by orthodontic non-specialists with the graphic chart
Dental exam by orthodontic experts
OTHERDetection of the presence of at least one malocclusion by orthodontic experts
Interventions
Visual examination of the child oral cavity bi non-orthodontist experts and orthodontist expert
Consultation with an orthodontics specialist if a malocclusion requiring early intervention is detected
Telephone call back at six months of inclusion in the study if a malocclusion requiring early intervention is detected
Eligibility Criteria
You may qualify if:
- child between 5 and 10 years old
- seen in consultation with pediatrician, pediatric dentist, or general dentist,
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Hôpital de jour pédiatrique - Hôpital Louis Mourier
Colombes, 92700, France
Odontologie Pédiatrique - Hôpital Louis Mourier
Colombes, 92700, France
Servide d'odontologie - Hôpital Louis Mourier
Colombes, 92700, France
Endocrinologie et diabète de l'enfant - Hôpital Bicêtre
Le Kremlin-Bicêtre, 94270, France
Neurologie Pédiatrique - Hôpital Bicêtre
Le Kremlin-Bicêtre, 94270, France
Cabinet d'odontologie pédiatrique
Montrouge, 92120, France
Cabinet privé pédiatrique
Paris, 75009, France
Cabinet privé pédodontie
Paris, 75014, France
Odontologie Pédiatrique - Hôpital Bretonneau
Paris, 75018, France
Service d'odontologie - Hôpital Bretonneau
Paris, 75018, France
Cabinet privé d'odontologie
Paris, Paris, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2019
First Posted
June 19, 2019
Study Start
October 21, 2020
Primary Completion
November 5, 2022
Study Completion
June 1, 2023
Last Updated
September 5, 2023
Record last verified: 2023-09