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Completed

NCT Number: NCT04869839

Oral Functions and Malocclusions

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.

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Key information

Age range

10 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nice University Hospital

Nice, 06000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All the pupils benefit from the clinical examination

Exclusion criteria

  • NONE

Treatment and study plan

oral examination

Other

examination done by dentist

Primary outcomes

  1. 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;
  2. 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)
  3. Dental malocclusion - intraoral examination

    Time frame: 1 day

    Dental malocclusion as defined by the HAS:

    , number of patient with shifted midlines ,

  4. Dental malocclusion - intraoral examination

    Time frame: 1 day

    Dental malocclusion as defined by the HAS:

    number of patient with an overbite (overbite> 2mm)

  5. Dental malocclusion - intraoral examination

    Time frame: 1 day

    Dental malocclusion as defined by the HAS:

    number of patient with an open bite (overbite <0)

Secondary outcomes

  1. Functional oral examination - ventilation

    Time frame: 1 day

    The functional pral examination includes improper mouth breathing: type of ventilation -1:

    Number of patient with adenoid facies

  2. Functional oral examination - ventilation

    Time frame: 1 day

    The functional examination includes improper mouth breathing: type of ventilation - 2 Number of patient with a positive Glaze's test

  3. Functional oral examination - ventilation

    Time frame: 1 day

    The functional examination includes improper mouth breathing: type of ventilation - 3 Number of patient with a positive Rosenthal's test

  4. Functional oral examination - deglutition

    Time frame: 1 day

    The functional examination includes abnormal deglutition. Number of patient with an abnormal déglutition (clinical exam)

  5. Functional oral examination - position of tongue

    Time frame: 1 day

    The functional examination includes i incorrect position of tongue at rest. number of patient with en incorrect position of the tongue (clinical exam)

  6. Oral health

    Time frame: 1 day

    • 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)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

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

Acronym: MALODYS

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 3, 2021
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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