MalocclusionMALODYSNCT04869839
Oral Functions and Malocclusions
An observational study of Malocclusion, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
The aim of our research is to establish a link between malocclusions and oral dysfunctions. The clinical examination includes: caries screening (DMFT and dft scores), a quantification of dental plaque (Silness and Loë's plaque index) and orthodontic treatment need (Haute Autorité de Santé HAS). Read more about this study
- Who is it for?
- Ages 10 to 12 years
- Conditions the study is for
- Malocclusion
- What is being tested?
- oral examination
- Type of treatment
- Pill or oral medicine
- How many people
- 359 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2017to 31 May 2017
- Phase
- Observational
- 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 10 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Comprehensive study involving all six-grade schoolchildren in Cagnes sur mer, Alpes Maritimes, France
Who may be able to join
- All the pupils benefit from the clinical examination
Who cannot join
- NONE
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral Functions and Malocclusions: a Comprehensive Epidemiological Study on 358 Schoolchildren in France
The aim of our research is to establish a link between malocclusions and oral dysfunctions. The clinical examination includes: caries screening (DMFT and dft scores), a quantification of dental plaque (Silness and Loë's plaque index) and orthodontic treatment need (Haute Autorité de Santé HAS). The functional examination includes improper mouth breathing, abnormal deglutition and incorrect position of tongue at rest.
- Conditions
- Malocclusion
- Being tested
- oral examination
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral examinationOther
examination done by dentist
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental malocclusion - extraoral examination
Dental malocclusion as defined by the HAS:
- An extraoral examination: sub-nasal profile, the sub-nasal angle and the labial-mental groove;
Measured: 1 day
Dental malocclusion - intraoral examination
Dental malocclusion as defined by the HAS:
- An intraoral examination: right and left molar dental class (Angle classification, overjet (abnormal when> 3mm)
Measured: 1 day
Dental malocclusion - intraoral examination
Dental malocclusion as defined by the HAS:
, number of patient with shifted midlines ,
Measured: 1 day
Dental malocclusion - intraoral examination
Dental malocclusion as defined by the HAS:
number of patient with an overbite (overbite> 2mm)
Measured: 1 day
Dental malocclusion - intraoral examination
Dental malocclusion as defined by the HAS:
number of patient with an open bite (overbite <0)
Measured: 1 day
Secondary outcomes (6)
Functional oral examination - ventilation
The functional pral examination includes improper mouth breathing: type of ventilation -1:
Number of patient with adenoid facies
Measured: 1 day
Functional oral examination - ventilation
The functional examination includes improper mouth breathing: type of ventilation - 2 Number of patient with a positive Glaze's test
Measured: 1 day
Functional oral examination - ventilation
The functional examination includes improper mouth breathing: type of ventilation - 3 Number of patient with a positive Rosenthal's test
Measured: 1 day
Functional oral examination - deglutition
The functional examination includes abnormal deglutition. Number of patient with an abnormal déglutition (clinical exam)
Measured: 1 day
Functional oral examination - position of tongue
The functional examination includes i incorrect position of tongue at rest. number of patient with en incorrect position of the tongue (clinical exam)
Measured: 1 day
Oral health
- Index of the severity of the caries disease (DMFT and dft);
- Silness and Loë's plaque index (0: absence of plaque, 1: plaque not visible to the naked eye but detachable with the probe; 2: plaque visible to the naked eye; 3: abundant plaque visible to the naked eye in the sulcus and on the marginal gingiva)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start1 Jan 2017
- Primary completion1 Feb 2017
- Study completion31 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalocclusionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 359 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04869839
- Sponsor's protocol ID
- 21Odonto01
- Acronym
- MALODYS
- Status last verified
- Apr 2021
- First submitted
- 27 Apr 2021
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Functions and Malocclusions: a Comprehensive Epidemiological Study on 358 Schoolchildren in France
- ClinicalTrials.gov ID
- NCT04869839
- Acronym / sponsor ID
- MALODYS / 21Odonto01
- Conditions
- Malocclusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 359 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Feb 2017 (actual)
- Study completion
- 31 May 2017 (actual)
- First posted
- 3 May 2021 (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.
The aim of our research is to establish a link between malocclusions and oral dysfunctions. The clinical examination includes: caries screening (DMFT and dft scores), a quantification of dental plaque (Silness and Loë's plaque index) and orthodontic treatment need (Haute Autorité de Santé HAS). The functional examination includes improper mouth breathing, abnormal deglutition and incorrect position of tongue at rest.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 10 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Comprehensive study involving all six-grade schoolchildren in Cagnes sur mer, Alpes Maritimes, France
Key inclusion criteria (1 listed)
- All the pupils benefit from the clinical examination
Key exclusion criteria (1 listed)
- NONE
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 |
|---|---|---|
| oral examinationexamination done by dentist | Other | – |
Primary outcome
Dental malocclusion - extraoral examination
Time frame: 1 day
Dental malocclusion as defined by the HAS: - An extraoral examination: sub-nasal profile, the sub-nasal angle and the labial-mental groove;
Dental malocclusion - intraoral examination
Time frame: 1 day
Dental malocclusion as defined by the HAS: - An intraoral examination: right and left molar dental class (Angle classification, overjet (abnormal when> 3mm)
Dental malocclusion - intraoral examination
Time frame: 1 day
Dental malocclusion as defined by the HAS: , number of patient with shifted midlines ,
Dental malocclusion - intraoral examination
Time frame: 1 day
Dental malocclusion as defined by the HAS: number of patient with an overbite (overbite> 2mm)
Dental malocclusion - intraoral examination
Time frame: 1 day
Dental malocclusion as defined by the HAS: number of patient with an open bite (overbite <0)
6 secondary outcomes
Functional oral examination - ventilation
Time frame: 1 day
Functional oral examination - ventilation
Time frame: 1 day
Functional oral examination - ventilation
Time frame: 1 day
Functional oral examination - deglutition
Time frame: 1 day
Functional oral examination - position of tongue
Time frame: 1 day
Oral health
Time frame: 1 day
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 10 Apr 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malocclusion, run by Centre Hospitalier Universitaire de Nice at 1 site 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 1 inclusion and 1 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 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Dental malocclusion - extraoral examination (time frame: 1 day). The study lists 5 primary outcomes in all. 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 10 Apr 2025.