EPIECC: Epidemiological Profile of Children With Early Caries.

Sponsor
University Hospital, Lille (Other)
Overall Status
Recruiting
CT.gov ID
NCT04195607
Collaborator
(none)
300
1
28.4
10.6

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    300 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Epidemiological Profile of Children With Early Caries: a Study in the Hauts-de-France Region
    Actual Study Start Date :
    Nov 19, 2019
    Anticipated Primary Completion Date :
    Apr 1, 2022
    Anticipated Study Completion Date :
    Apr 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Evaluation of the image that parents have of dental health and carious disease [at day one]

      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.

    2. Evaluation of the image that parents have of dental health and carious disease [at day one]

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

    3. Evaluation of the image that parents have of dental health and carious disease [at day one]

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

    4. Evaluation of the image that parents have of dental health and carious disease [at day one]

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

    5. Evaluation of the image that parents have of dental health and carious disease [at day one]

      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.

    6. Evaluation of the image that parents have of dental health and carious disease [at day one]

      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".

    7. Evaluation of the image that parents have of dental health and carious disease [at day one]

      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.

    8. Evaluation of the image that parents have of dental health and carious disease [at day one]

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

    9. Evaluation of the image that parents have of dental health and carious disease [at day one]

      Distress of parents : evaluation using a series of 6 questions

    10. Evaluation of the image that parents have of dental health and carious disease [at day one]

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

    11. Evaluation of the image that parents have of dental health and carious disease [at day one]

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

    12. Evaluation of the image that parents have of dental health and carious disease [at day one]

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

    13. Evaluation of the image that parents have of dental health and carious disease [at day one]

      Health literacy : evaluated using a single-question answer.

    14. Evaluation of the image that parents have of dental health and carious disease [at day one]

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

    Secondary Outcome Measures

    1. frequency of patients with severe early caries in patients with early caries. [at day one]

      Number of children with early stage severe caries according to the criteria of the American Academy of Pediatric Dentistry

    2. Caries severity will be defined by the Severe Early Childhood Caries (S-ECC) [at day one]

      This term is used if at least one of the following conditions is met: Smooth surfaces of teeth are affected in a child under 3 years of age; There is one or more caried anterior tooth(s), missing due to caries or fillings The caod index* > 4 to 3 years, > 5 to 4 years or >6 to 5 years: the caod index indicates the number of temporary teeth decayed, absent due to caring or filling. It is between 0 and 20

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 6 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • 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

    Exclusion Criteria:
    • be a child over the age of 6

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Service d'Odontologie CHU Lille France 59000

    Sponsors and Collaborators

    • University Hospital, Lille

    Investigators

    • Principal Investigator: Thomas Marquillier, DDS, University Hospital, Lille

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Lille
    ClinicalTrials.gov Identifier:
    NCT04195607
    Other Study ID Numbers:
    • RNI_2018_97
    • 2019-A00827-50
    First Posted:
    Dec 12, 2019
    Last Update Posted:
    Oct 5, 2021
    Last Verified:
    Oct 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 5, 2021