Oral Functions and Malocclusions (MALODYS)

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.

Study Overview

• Status: Completed
• Conditions: Malocclusion
• Intervention / Treatment: Other: oral examination

• Study Type: Observational
• Enrollment (Actual): 400

Contacts and Locations

Study Locations

• France
  • Nice, France, 06000
    • Nice University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Comprehensive study involving all six-grade schoolchildren in Cagnes sur mer, Alpes Maritimes, France

Description

Inclusion Criteria:

• All the pupils benefit from the clinical examination

Exclusion Criteria:

• NONE

Study Plan

How is the study designed?

Design Details

• Observational Models: Ecologic or Community
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional oral examination - ventilation	The functional pral examination includes improper mouth breathing: type of ventilation -1: Number of patient with adenoid facies	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	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	1 day
Functional oral examination - deglutition	The functional examination includes abnormal deglutition. Number of patient with an abnormal déglutition (clinical exam)	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)	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)	1 day

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: April 27, 2021
• First Submitted That Met QC Criteria: April 30, 2021
• First Posted (Actual): May 3, 2021

Study Record Updates

• Last Update Posted (Actual): May 3, 2021
• Last Update Submitted That Met QC Criteria: April 30, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion
• Other Study ID Numbers: 21Odonto01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No