NCT04869839

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
359

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2017

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

April 27, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 3, 2021

Completed
Last Updated

April 10, 2025

Status Verified

April 1, 2021

Enrollment Period

1 month

First QC Date

April 27, 2021

Last Update Submit

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

Age10 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

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

Location

MeSH Terms

Conditions

Malocclusion

Interventions

Diagnosis, Oral

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dentistry

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

Locations