NCT04795258

Brief Summary

Few oral exams are performed on 6-year-olds (key age for carious disease). This project aims to increase the number of oral check-ups for 6-year-olds in fragile areas (REP/REP+ areas).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
671

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

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, 2021

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 9, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 12, 2021

Completed
Last Updated

March 18, 2021

Status Verified

March 1, 2021

Enrollment Period

29 days

First QC Date

March 9, 2021

Last Update Submit

March 15, 2021

Conditions

Dental Caries

Keywords

Oral hygienePublic HealthChildrenPrevention

Outcome Measures

Primary Outcomes (2)

  • Presence of decay on each tooth present in the mouth

    Presence of decay on each tooth present in the mouth

    1 day

  • Presence of care on each tooth present in the mouth

    Presence of care on each tooth present in the mouth

    1 day

Eligibility Criteria

Age5 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

first-grade student enrolled in a school in a zone REP/REP+

You may qualify if:

  • Be a first-grade student enrolled in a school in a zone REP/REP+
  • Have a parental permission
  • Good understanding of the French language

You may not qualify if:

  • \- lack of parental permission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Camille INQUIMBERT, PhD

    University Hospital, Montpellier

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2021

First Posted

March 12, 2021

Study Start

January 1, 2021

Primary Completion

January 30, 2021

Study Completion

March 1, 2021

Last Updated

March 18, 2021

Record last verified: 2021-03

Locations

FR(1)