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

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ClinicalTrials.gov Identifier: NCT03991221
Recruitment Status : Recruiting
First Posted : June 19, 2019
Last Update Posted : March 22, 2021
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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
Dental Malocclusion Other: Dental Exam Other: Orthodontics consult Other: Call back at 6 month Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 21, 2020
Estimated Primary Completion Date : March 15, 2022
Estimated Study Completion Date : November 15, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Orthodontia

Arm Intervention/treatment
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

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




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) [ Time Frame: 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 [ Time Frame: 2 months ]
  2. Prevalence of malocclusions identified by orthodontic experts [ Time Frame: 2 months ]
  3. Number of orthodontic consultations within 6 months among children screened for a malocclusion reacquiring early orthodontic treatment [ Time Frame: 6 months ]
  4. Number of orthodontic treatments started within 6 months among children screened for a malocclusion reacquiring early orthodontic treatment [ Time Frame: 6 months ]


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03991221


Contacts
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Contact: ELVIRE LE NORCY, DDS 0762965050 ext 33 elvire.lenorcy@aphp.fr
Contact: Aline DECHANET 0140257830 aline.dechanet@aphp.fr

Locations
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France
Hôpital de jour pédiatrique - Hôpital Louis Mourier Recruiting
Colombes, France, 92700
Contact: Bettina MESPLES    01 47 60 64 30    bettina.mesples@aphp.fr   
Odontologie Pédiatrique - Hôpital Louis Mourier Recruiting
Colombes, France, 92700
Contact: Sibylle VITAL    01 47 60 61 74    sibylle.vital@parisdescartes.frsibylle.vital@aphp.fr   
Servide d'odontologie - Hôpital Louis Mourier Active, not recruiting
Colombes, France, 92700
Endocrinologie et diabète de l'enfant - Hôpital Bicêtre Recruiting
Le Kremlin-Bicêtre, France, 94270
Contact: Agnès LINGLART    01 45 21 78 53    agnes.linglart@aphp.fr   
Neurologie Pédiatrique - Hôpital Bicêtre Recruiting
Le Kremlin-Bicêtre, France, 94270
Contact: Kumaran DEIVA    01 45 21 31 58    kumaran.deiva@aphp.fr   
Cabinet d'odontologie pédiatrique Not yet recruiting
Montrouge, France, 92120
Contact: Romain JACQ    01 47 35 40 92    romainjacq@gmail.com   
Cabinet Chirurgien-dentiste Not yet recruiting
Neuilly-sur-Seine, France, 92200
Contact: Anne-Sophie GHARIANI    01 46 37 27 25    annesophieghariani@orange.fr   
Cabinet privé pédiatrique Recruiting
Paris, France, 75009
Contact: Gwenaëlle D'ACREMONT    01 48 00 84 48    gwendacremont@gmail.com   
Odontologie Pédiatrique - Hôpital Bretonneau Recruiting
Paris, France, 75018
Contact: Violaine SAMIL-FAUGERON    01 53 11 14 15    viosmail@orange.fr   
Service d'odontologie - Hôpital Bretonneau Recruiting
Paris, France, 75018
Contact: Fleur BERES    01 44 27 55 00    fleur_beres@hotmail.fr   
Cabinet Privé d'odontologie pédiatrique Not yet recruiting
Paris, France, 75116
Contact: Anne-Sophie POROT    01 85 00 80 66    dr.asophie.porot@gmail.com   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03991221    
Other Study ID Numbers: APHP180562
2019-A01074-53 ( Other Identifier: IDRCB )
First Posted: June 19, 2019    Key Record Dates
Last Update Posted: March 22, 2021
Last Verified: March 2021

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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:
Prevention
Early treatment
Skeletal discrepancy
Malocclusion
Additional relevant MeSH terms:
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Malocclusion
Tooth Diseases
Stomatognathic Diseases