Oral Functions and Malocclusions
MALODYS
1 other identifier
observational
359
1 country
1
Brief 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). The functional examination includes improper mouth breathing, abnormal deglutition and incorrect position of tongue at rest.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2017
Shorter than P25 for all trials
1 active site
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
Study Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2017
CompletedFirst Submitted
Initial submission to the registry
April 27, 2021
CompletedFirst Posted
Study publicly available on registry
May 3, 2021
CompletedApril 10, 2025
April 1, 2021
1 month
April 27, 2021
April 9, 2025
Conditions
Outcome Measures
Primary Outcomes (5)
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;
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)
1 day
Dental malocclusion - intraoral examination
Dental malocclusion as defined by the HAS: , number of patient with shifted midlines ,
1 day
Dental malocclusion - intraoral examination
Dental malocclusion as defined by the HAS: number of patient with an overbite (overbite\> 2mm)
1 day
Dental malocclusion - intraoral examination
Dental malocclusion as defined by the HAS: number of patient with an open bite (overbite \<0)
1 day
Secondary Outcomes (6)
Functional oral examination - ventilation
1 day
Functional oral examination - ventilation
1 day
Functional oral examination - ventilation
1 day
Functional oral examination - deglutition
1 day
Functional oral examination - position of tongue
1 day
- +1 more secondary outcomes
Interventions
examination done by dentist
Eligibility Criteria
Comprehensive study involving all six-grade schoolchildren in Cagnes sur mer, Alpes Maritimes, France
You may qualify if:
- All the pupils benefit from the clinical examination
You may not qualify if:
- NONE
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nice University Hospital
Nice, 06000, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- ECOLOGIC OR COMMUNITY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2021
First Posted
May 3, 2021
Study Start
January 1, 2017
Primary Completion
February 1, 2017
Study Completion
May 31, 2017
Last Updated
April 10, 2025
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share