Epidemiological Profile of Children With Early Caries.

Dental Caries Clinical Trial

— EPIECC  

Official title:

Epidemiological Profile of Children With Early Caries: a Study in the Hauts-de-France Region

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04195607
• Other study ID #: RNI_2018_97
• Secondary ID: 2019-A00827-50
• Status: Recruiting
• Start date: November 19, 2019
• Est. completion date: May 2023

Study information

• Verified date: January 2023
• Source: University Hospital, Lille
• Contact: Thomas Marquillier, DDS
• Phone: 03.20.44.67.67
• Email: thomas.marquillier[@]univ-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: May 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries

Locations

Country	Name	City	State
France	Service d'Odontologie CHU	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Evaluation of the image that parents have of dental health and carious disease	Health literacy : evaluated using a single-question answer.	at day one
Primary	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	frequency of patients with severe early caries in patients with early caries.	Number of children with early stage severe caries according to the criteria of the American Academy of Pediatric Dentistry	at day one
Secondary	Caries severity will be defined by the Severe Early Childhood Caries (S-ECC)	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	at day one