Dental CariesEPIECCNCT04195607
Epidemiological Profile of Children With Early Caries.
An observational study of Dental Caries, run by University Hospital, Lille at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Dental Caries
- How many people
- 298 participants
- Where
- 1 siteFrance
- Study dates
- 19 Nov 2019to 14 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 6 years
- All sexes
- No healthy volunteers
- Child
Study population: children with early caries who consult at the CHU in Lille.
Who may be able to join
- 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
Who cannot join
- be a child over the age of 6
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Epidemiological Profile of Children With Early Caries: a Study in the Hauts-de-France Region
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
- Conditions
- Dental Caries
- Medical subject headings
- Dental Caries
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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".
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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".
Measured: 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.
Measured: at day one
Evaluation of the image that parents have of dental health and carious disease
Health literacy : evaluated using a single-question answer.
Measured: 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.
Measured: at day one
Secondary outcomes (2)
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
Measured: at day one
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
Measured: at day one
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start19 Nov 2019
- Primary completion14 Dec 2023
- Study completion14 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 298 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Marquillier, DDS, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04195607
- Sponsor's protocol ID
- RNI_2018_97
- Other IDs
- 2019-A00827-50
- Acronym
- EPIECC
- Status last verified
- Dec 2025
- First submitted
- 4 Dec 2019
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40578875
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Profile of Children With Early Caries: a Study in the Hauts-de-France Region
- ClinicalTrials.gov ID
- NCT04195607
- Acronym / sponsor ID
- EPIECC / RNI_2018_97
- Conditions
- Dental Caries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 298 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 19 Nov 2019 (actual)
- Primary completion
- 14 Dec 2023 (actual)
- Study completion
- 14 Dec 2023 (actual)
- First posted
- 12 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- children with early caries who consult at the CHU in Lille.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- be a child over the age of 6
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of the image that parents have of dental health and carious disease
Time frame: 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.
Evaluation of the image that parents have of dental health and carious disease
Time frame: at day one
Parents' dental health knowledge : success score on a series of 7 questions about Oral Health Knowledge.
Evaluation of the image that parents have of dental health and carious disease
Time frame: 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.
Evaluation of the image that parents have of dental health and carious disease
Time frame: at day one
dental health behaviours of parents : success score on a series of 7 questions about oral health knowledge.
Evaluation of the image that parents have of dental health and carious disease
Time frame: 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.
Evaluation of the image that parents have of dental health and carious disease
Time frame: 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".
Evaluation of the image that parents have of dental health and carious disease
Time frame: 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.
Evaluation of the image that parents have of dental health and carious disease
Time frame: at day one
Parents' dental health beliefs : evaluating the parents' dental health beliefs using a score on a series of 17 oral health questions.
Evaluation of the image that parents have of dental health and carious disease
Time frame: at day one
Distress of parents : evaluation using a series of 6 questions
Evaluation of the image that parents have of dental health and carious disease
Time frame: at day one
Chronic stress of parents : evaluation using a series of 2 questions.
Evaluation of the image that parents have of dental health and carious disease
Time frame: at day one
Social support : "how many people around you can count on when needed".
Evaluation of the image that parents have of dental health and carious disease
Time frame: at day one
Discrimination perceived by parents : evaluation using a response score to the 7 questions asked.
Evaluation of the image that parents have of dental health and carious disease
Time frame: at day one
Health literacy : evaluated using a single-question answer.
Evaluation of the image that parents have of dental health and carious disease
Time frame: at day one
Alcohol use among parents : evaluated using a three-question answer on frequency of alcohol consumption and quantity.
2 secondary outcomes
frequency of patients with severe early caries in patients with early caries.
Time frame: at day one
Caries severity will be defined by the Severe Early Childhood Caries (S-ECC)
Time frame: at day one
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Results publication: PubMed 40578875Craquelin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Marquillier, DDS principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Caries, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the image that parents have of dental health and carious disease (time frame: at day one). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04195607, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.