NCT07377240 Study of Obstacles and Barriers to Changing Risky Eating Behaviors in Families of Children With Severe Early Childhood Caries (QUALIKIDS).
| NCT ID | NCT07377240 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Clermont-Ferrand |
| Condition | Early Childhood Caries |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-07-10 |
| Primary Completion | 2028-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2026-07-10 with a primary completion date of 2028-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Dental caries is the most common chronic disease in children, and its early form-Early Childhood Caries (ECC)-which particularly affects children under the age of six, represents a major public health problem worldwide. This disease has a negative impact on the quality of life of affected children and their families, and leads to significant functional and developmental consequences. Moreover, due to their young age, these children require specialized care and adapted treatment procedures, particularly the use of general anesthesia (GA) for comprehensive oral rehabilitation. This conservative therapeutic approach improves the quality of life and orofacial functions of the children concerned, particularly their masticatory ability. However, there remains a significant rate of caries recurrence within the year following treatment. This is largely due to the difficulty families face in changing the dietary habits that contribute to the disease, such as the frequent consumption of sugar-rich foods in all their forms. These families are often bio-psycho-socially vulnerable and have a low level of oral health literacy. They also tend to show lower adherence to preventive measures (oral hygiene practices and regular dental check-ups for children) as well as to the health education and therapeutic interventions proposed to them. In order to stabilize dental caries in these children, prevent repeated procedures due to recurrent caries, and offer interventions tailored to their needs, it is essential to better understand why oral health behaviors are so difficult to change within these families. This study aims to adopt a qualitative approach to explore the obstacles and barriers to modifying etiological behaviors, particularly dietary behaviors, in families of young children with severe ECC treated under general anesthesia in the specialized care unit of Handiconsult ARA Ouest (CHU Estaing Clermont-Ferrand - CH Riom). Semi-structured, face-to-face interviews conducted with one or both parents will investigate the different dimensions of this issue. A subgroup analysis will compare the factors influencing the adoption of oral health-promoting habits in families of children with and without associated developmental disorders.
Eligibility Criteria
Inclusion Criteria: * All parents of children under 6 years of age with CPE-S, consulting the specialized dental care unit as part of the Handiconsult ARA Ouest program for complete conservative oral rehabilitation under general anesthesia * Verbal agreement from the participant to take part in the study and for audio recording * Parents who understand and speak French. Exclusion Criteria: * Parents of children in foster care. * Parents under judicial protection, guardianship, or conservatorship. * Parents who refuse to participate in the study.
Contact & Investigator
Valérie Collado
PRINCIPAL INVESTIGATOR
University Hospital, Clermont-Ferrand
Frequently Asked Questions
Who can join the NCT07377240 clinical trial?
This trial is open to participants of all sexes, studying Early Childhood Caries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07377240 currently recruiting?
Yes, NCT07377240 is actively recruiting participants. Contact the research team at promo_interne_drci@chu-clermontferrand.fr for enrollment information.
Where is the NCT07377240 trial being conducted?
This trial is being conducted at Clermont-Ferrand, France.
Who is sponsoring the NCT07377240 clinical trial?
NCT07377240 is sponsored by University Hospital, Clermont-Ferrand. The principal investigator is Valérie Collado at University Hospital, Clermont-Ferrand. The trial plans to enroll 30 participants.