Oral Functions and Malocclusions

Malocclusion Clinical Trial

— MALODYS  

Official title:

Oral Functions and Malocclusions: a Comprehensive Epidemiological Study on 358 Schoolchildren in France

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04869839
• Other study ID #: 21Odonto01
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: December 1, 2017

Study information

• Verified date: April 2021
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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). The functional examination includes improper mouth breathing, abnormal deglutition and incorrect position of tongue at rest.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: December 1, 2017
• Est. primary completion date: February 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 12 Years

Eligibility

Inclusion Criteria:

• All the pupils benefit from the clinical examination

Exclusion Criteria:

• NONE

Related Conditions & MeSH terms

• Malocclusion

Intervention

Other:
• oral examination
examination done by dentist

Locations

Country	Name	City	State
France	Nice University Hospital	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Dental malocclusion - intraoral examination	Dental malocclusion as defined by the HAS: , number of patient with shifted midlines ,	1 day
Primary	Dental malocclusion - intraoral examination	Dental malocclusion as defined by the HAS: number of patient with an overbite (overbite> 2mm)	1 day
Primary	Dental malocclusion - intraoral examination	Dental malocclusion as defined by the HAS: number of patient with an open bite (overbite <0)	1 day
Secondary	Functional oral examination - ventilation	The functional pral examination includes improper mouth breathing: type of ventilation -1: Number of patient with adenoid facies	1 day
Secondary	Functional oral examination - ventilation	The functional examination includes improper mouth breathing: type of ventilation - 2 Number of patient with a positive Glaze's test	1 day
Secondary	Functional oral examination - ventilation	The functional examination includes improper mouth breathing: type of ventilation - 3 Number of patient with a positive Rosenthal's test	1 day
Secondary	Functional oral examination - deglutition	The functional examination includes abnormal deglutition. Number of patient with an abnormal déglutition (clinical exam)	1 day
Secondary	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)	1 day
Secondary	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)	1 day