Dental MalocclusionCHARTE-ODFNCT03991221
Validation of Dental Malocclusion Schematic Representations for Early Orthodontic Treatment
A study testing Dental Exam, Orthodontics consult and Call back at 6 month in people with Dental Malocclusion, run by Assistance Publique - Hôpitaux de Paris at 11 sites in France.
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. Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Dental Malocclusion
- What is being tested?
- Dental Exam, Orthodontics consult and Call back at 6 month
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 659 participants
- Where
- 11 sitesFrance
- Study dates
- 21 Oct 2020to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- child between 5 and 10 years old
- seen in consultation with pediatrician, pediatric dentist, or general dentist,
Who cannot join
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
Hôpital de jour pédiatrique - Hôpital Louis Mourier
Colombes, 92700
Odontologie Pédiatrique - Hôpital Louis Mourier
Colombes, 92700
Servide d'odontologie - Hôpital Louis Mourier
Colombes, 92700
Endocrinologie et diabète de l'enfant - Hôpital Bicêtre
Le Kremlin-Bicêtre, 94270
Neurologie Pédiatrique - Hôpital Bicêtre
Le Kremlin-Bicêtre, 94270
Cabinet d'odontologie pédiatrique
Montrouge, 92120
Cabinet privé pédiatrique
Paris, 75009
Cabinet privé pédodontie
Paris, 75014
Odontologie Pédiatrique - Hôpital Bretonneau
Paris, 75018
Service d'odontologie - Hôpital Bretonneau
Paris, 75018
Cabinet privé d'odontologie
Paris, Paris
About this study
Official title: Validation of Schematic Representations for Dental Malocclusion and Craniofacial Deformities Screening in Temporary and Mixed Dentition Requiring Early Orthodontic Treatment
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.
Read more
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.
Read the 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).
- Conditions
- Dental Malocclusion
- Being tested
- Dental Exam, Orthodontics consult, Call back at 6 month
- Keywords
- Prevention, Early treatment, Skeletal discrepancy, Malocclusion
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental ExamOther
Visual examination of the child oral cavity bi non-orthodontist experts and orthodontist expert
Orthodontics consultOther
Consultation with an orthodontics specialist if a malocclusion requiring early intervention is detected
Call back at 6 monthOther
Telephone call back at six months of inclusion in the study if a malocclusion requiring early intervention is detected
| Study group | Role | What they receive |
|---|---|---|
| Dental exam by orthodontic non-specialists | Other | Detection of the presence of at least one malocclusion by orthodontic non-specialists with the graphic chart Receives: Other: Dental Exam |
| Dental exam by orthodontic experts | Other | Detection of the presence of at least one malocclusion by orthodontic experts Receives: Other: Dental Exam; Other: Orthodontics consult; Other: Call back at 6 month |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 2 months
Secondary outcomes (4)
Detection of each type of malocclusion requiring early orthodontic treatment by non-orthodontist practitioners versus orthodontic experts
Measured: 2 months
Prevalence of malocclusions identified by orthodontic experts
Measured: 2 months
Number of orthodontic consultations within 6 months among children screened for a malocclusion reacquiring early orthodontic treatment
Measured: 6 months
Number of orthodontic treatments started within 6 months among children screened for a malocclusion reacquiring early orthodontic treatment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2019
- Study start21 Oct 2020
- Primary completion5 Nov 2022
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental MalocclusionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 659 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03991221
- Sponsor's protocol ID
- APHP180562
- Other IDs
- 2019-A01074-53
- Acronym
- CHARTE-ODF
- Status last verified
- Sep 2023
- First submitted
- 24 May 2019
- Last updated
- 5 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Schematic Representations for Dental Malocclusion and Craniofacial Deformities Screening in Temporary and Mixed Dentition Requiring Early Orthodontic Treatment
- ClinicalTrials.gov ID
- NCT03991221
- Acronym / sponsor ID
- CHARTE-ODF / APHP180562
- Conditions
- Dental Malocclusion
- Keywords
- Prevention, Early treatment, Skeletal discrepancy, Malocclusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 659 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 21 Oct 2020 (actual)
- Primary completion
- 5 Nov 2022 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 19 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dental exam by orthodontic non-specialists | Other | Other: Dental ExamDetection of the presence of at least one malocclusion by orthodontic non-specialists with the graphic chart |
| Dental exam by orthodontic experts | Other | Other: Dental Exam, Other: Orthodontics consult, Other: Call back at 6 monthDetection of the presence of at least one malocclusion by orthodontic experts |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- child between 5 and 10 years old
- seen in consultation with pediatrician, pediatric dentist, or general dentist,
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dental ExamVisual examination of the child oral cavity bi non-orthodontist experts and orthodontist expert | Other | Dental exam by orthodontic experts, Dental exam by orthodontic non-specialists |
| Orthodontics consultConsultation with an orthodontics specialist if a malocclusion requiring early intervention is detected | Other | Dental exam by orthodontic experts |
| Call back at 6 monthTelephone call back at six months of inclusion in the study if a malocclusion requiring early intervention is detected | Other | Dental exam by orthodontic experts |
Primary outcome
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)
4 secondary outcomes
Detection of each type of malocclusion requiring early orthodontic treatment by non-orthodontist practitioners versus orthodontic experts
Time frame: 2 months
Prevalence of malocclusions identified by orthodontic experts
Time frame: 2 months
Number of orthodontic consultations within 6 months among children screened for a malocclusion reacquiring early orthodontic treatment
Time frame: 6 months
Number of orthodontic treatments started within 6 months among children screened for a malocclusion reacquiring early orthodontic treatment
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dental Exam, Orthodontics consult and Call back at 6 month in people with Dental Malocclusion, run by Assistance Publique - Hôpitaux de Paris at 11 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2023.