Validation of Dental Malocclusion Schematic Representations for Early Orthodontic Treatment (CHARTE-ODF)
Primary Purpose
Dental Malocclusion
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Dental Exam
Orthodontics consult
Call back at 6 month
Sponsored by
About this trial
This is an interventional prevention trial for Dental Malocclusion focused on measuring Prevention, Early treatment, Skeletal discrepancy, Malocclusion
Eligibility Criteria
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
Sites / Locations
- Hôpital de jour pédiatrique - Hôpital Louis Mourier
- Odontologie Pédiatrique - Hôpital Louis Mourier
- Servide d'odontologie - Hôpital Louis Mourier
- Endocrinologie et diabète de l'enfant - Hôpital Bicêtre
- Neurologie Pédiatrique - Hôpital Bicêtre
- Cabinet d'odontologie pédiatrique
- Cabinet privé pédiatrique
- Cabinet privé pédodontie
- Odontologie Pédiatrique - Hôpital Bretonneau
- Service d'odontologie - Hôpital Bretonneau
- Cabinet privé d'odontologie
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Dental exam by orthodontic non-specialists
Dental exam by orthodontic experts
Arm Description
Detection of the presence of at least one malocclusion by orthodontic non-specialists with the graphic chart
Detection of the presence of at least one malocclusion by orthodontic experts
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Detection of each type of malocclusion requiring early orthodontic treatment by non-orthodontist practitioners versus orthodontic experts
Prevalence of malocclusions identified by orthodontic experts
Number of orthodontic consultations within 6 months among children screened for a malocclusion reacquiring early orthodontic treatment
Number of orthodontic treatments started within 6 months among children screened for a malocclusion reacquiring early orthodontic treatment
Full Information
NCT ID
NCT03991221
First Posted
May 24, 2019
Last Updated
September 1, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT03991221
Brief Title
Validation of Dental Malocclusion Schematic Representations for Early Orthodontic Treatment
Acronym
CHARTE-ODF
Official Title
Validation of Schematic Representations for Dental Malocclusion and Craniofacial Deformities Screening in Temporary and Mixed Dentition Requiring Early Orthodontic Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
October 21, 2020 (Actual)
Primary Completion Date
November 5, 2022 (Actual)
Study Completion Date
June 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Malocclusion
Keywords
Prevention, Early treatment, Skeletal discrepancy, Malocclusion
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
659 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dental exam by orthodontic non-specialists
Arm Type
Other
Arm Description
Detection of the presence of at least one malocclusion by orthodontic non-specialists with the graphic chart
Arm Title
Dental exam by orthodontic experts
Arm Type
Other
Arm Description
Detection of the presence of at least one malocclusion by orthodontic experts
Intervention Type
Other
Intervention Name(s)
Dental Exam
Intervention Description
Visual examination of the child oral cavity bi non-orthodontist experts and orthodontist expert
Intervention Type
Other
Intervention Name(s)
Orthodontics consult
Intervention Description
Consultation with an orthodontics specialist if a malocclusion requiring early intervention is detected
Intervention Type
Other
Intervention Name(s)
Call back at 6 month
Intervention Description
Telephone call back at six months of inclusion in the study if a malocclusion requiring early intervention is detected
Primary Outcome Measure Information:
Title
Detection the presence of at least one malocclusion in children, requiring an early orthodontic treatment, compared to orthodontic experts (gold-standard)
Description
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)
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Detection of each type of malocclusion requiring early orthodontic treatment by non-orthodontist practitioners versus orthodontic experts
Time Frame
2 months
Title
Prevalence of malocclusions identified by orthodontic experts
Time Frame
2 months
Title
Number of orthodontic consultations within 6 months among children screened for a malocclusion reacquiring early orthodontic treatment
Time Frame
6 months
Title
Number of orthodontic treatments started within 6 months among children screened for a malocclusion reacquiring early orthodontic treatment
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hôpital de jour pédiatrique - Hôpital Louis Mourier
City
Colombes
ZIP/Postal Code
92700
Country
France
Facility Name
Odontologie Pédiatrique - Hôpital Louis Mourier
City
Colombes
ZIP/Postal Code
92700
Country
France
Facility Name
Servide d'odontologie - Hôpital Louis Mourier
City
Colombes
ZIP/Postal Code
92700
Country
France
Facility Name
Endocrinologie et diabète de l'enfant - Hôpital Bicêtre
City
Le Kremlin-Bicêtre
ZIP/Postal Code
94270
Country
France
Facility Name
Neurologie Pédiatrique - Hôpital Bicêtre
City
Le Kremlin-Bicêtre
ZIP/Postal Code
94270
Country
France
Facility Name
Cabinet d'odontologie pédiatrique
City
Montrouge
ZIP/Postal Code
92120
Country
France
Facility Name
Cabinet privé pédiatrique
City
Paris
ZIP/Postal Code
75009
Country
France
Facility Name
Cabinet privé pédodontie
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Odontologie Pédiatrique - Hôpital Bretonneau
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
Service d'odontologie - Hôpital Bretonneau
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
Cabinet privé d'odontologie
City
Paris
ZIP/Postal Code
Paris
Country
France
12. IPD Sharing Statement
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Validation of Dental Malocclusion Schematic Representations for Early Orthodontic Treatment
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