NCT04195607

Brief Summary

The objective of the study is to determine the different profiles of patients with early caries consulting at the Lille CHU and to analyse the characteristics associated with the severity of the pathology. The data will be collected using a simple clinical examination of the child and a survey of the parent using a questionnaire. The typology of patients with early caries will be analysed according to the predefined variables collected using the questionnaire via a main component analysis in order to study the links between these variables. At the same time, a hierarchical classification analysis will be carried out to study the existence of homogeneous sub-groups of individuals in regard to the early caries. These sub-groups will be described

Trial Health

87
On Track

Trial Health Score

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

Enrollment
298

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2019

Longer than P75 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

November 19, 2019

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

December 4, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 12, 2019

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2023

Completed
Last Updated

December 23, 2025

Status Verified

December 1, 2025

Enrollment Period

4.1 years

First QC Date

December 4, 2019

Last Update Submit

December 17, 2025

Conditions

Outcome Measures

Primary Outcomes (14)

  • Evaluation of the image that parents have of dental health and carious disease

    Socio-demographic characteristics : country of birth of child, age of mother, country of birth of mother, level of education of mother (INSEE classification), occupation of mother (INSEE classification), maternal employment status (INSEE classification) , father's age, father's country of birth, father's educational level (INSEE classification), father's occupation (INSEE classification), father's work status (INSEE classification), number of children, number of people in same home, sibling rank with cavities, , distance between home and hospital.

    at day one

  • Evaluation of the image that parents have of dental health and carious disease

    Parents' dental health knowledge : success score on a series of 7 questions about Oral Health Knowledge.

    at day one

  • Evaluation of the image that parents have of dental health and carious disease

    Parental self-efficacy in dental health : evaluating the feeling of self-efficacy using a pass score on a series of 10 oral health questions.

    at day one

  • Evaluation of the image that parents have of dental health and carious disease

    dental health behaviours of parents : success score on a series of 7 questions about oral health knowledge.

    at day one

  • Evaluation of the image that parents have of dental health and carious disease

    Insurance, use, cost of care and modalities/use of pediatric dental care : social assistance, history of dental consultations in cities, number of practitioners consulted, difficulties in finding appropriate dental care for children, reason for consultation, renunciation of dental care for parent or child and reason, type of health coverage, cost of care.

    at day one

  • Evaluation of the image that parents have of dental health and carious disease

    Locus of control in parental dental health : assessment using a simple question: "do you think you are personally responsible for the presence of caries in your child".

    at day one

  • Evaluation of the image that parents have of dental health and carious disease

    Perceived importance of dental health behaviours among parents : evaluating the perceived importance of health behaviors using a score on a series of 14 oral health questions.

    at day one

  • Evaluation of the image that parents have of dental health and carious disease

    Parents' dental health beliefs : evaluating the parents' dental health beliefs using a score on a series of 17 oral health questions.

    at day one

  • Evaluation of the image that parents have of dental health and carious disease

    Distress of parents : evaluation using a series of 6 questions

    at day one

  • Evaluation of the image that parents have of dental health and carious disease

    Chronic stress of parents : evaluation using a series of 2 questions.

    at day one

  • Evaluation of the image that parents have of dental health and carious disease

    Social support : "how many people around you can count on when needed".

    at day one

  • Evaluation of the image that parents have of dental health and carious disease

    Discrimination perceived by parents : evaluation using a response score to the 7 questions asked.

    at day one

  • Evaluation of the image that parents have of dental health and carious disease

    Health literacy : evaluated using a single-question answer.

    at day one

  • Evaluation of the image that parents have of dental health and carious disease

    Alcohol use among parents : evaluated using a three-question answer on frequency of alcohol consumption and quantity.

    at day one

Secondary Outcomes (2)

  • frequency of patients with severe early caries in patients with early caries.

    at day one

  • Caries severity will be defined by the Severe Early Childhood Caries (S-ECC)

    at day one

Eligibility Criteria

Age1 Year - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

children with early caries who consult at the CHU in Lille.

You may qualify if:

  • be a child under the age of 6,
  • having been diagnosed with early caries
  • be accompanied by at least one parent (the mother or father).
  • be affiliated to a social security

You may not qualify if:

  • be a child over the age of 6

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service d'Odontologie CHU

Lille, 59000, France

Location

Related Publications (1)

  • Craquelin M, Trentesaux T, Delfosse C, Duhamel C, Matteucci R, Nonclercq S, Duhr A, Leblanc A, Behal H, Tiertant E, Lombrail P, Azogui-Levy S, Marquillier T. Family profiles in relation to early childhood caries: a cross-sectional study in France. BMJ Open. 2025 Jun 26;15(6):e100286. doi: 10.1136/bmjopen-2025-100286.

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Thomas Marquillier, DDS

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 4, 2019

First Posted

December 12, 2019

Study Start

November 19, 2019

Primary Completion

December 14, 2023

Study Completion

December 14, 2023

Last Updated

December 23, 2025

Record last verified: 2025-12

Locations