Construction of a Multidimensional Risk Prediction Model for Severe Early Childhood Caries (NCT07335744) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Construction of a Multidimensional Risk Prediction Model for Severe Early Childhood Caries
1,200 participantsStarted 2026-03-01
Plain-language summary
This study aims to address the high prevalence and recurrence rate of severe early childhood caries (S-ECC) by breaking away from the traditional single biological factor perspective and introducing the theories of "24-hour activity behavior" and "family psychological stress". By collecting clinical and behavioral data from 1,200 preschool children and their parents, it explores the association pathways between parental burnout, children's executive function, sleep/dietary behaviors and S-ECC, and builds a high-precision risk prediction model to provide evidence-based support for the clinical development of personalized prevention strategies.
Who can participate
Age range
3 Years – 6 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age range: 3-6 years old (36 months ≤ months \< 72 months);
* Good overall health condition (ASA classification I-II);
* Parents have given informed consent and are willing to participate in this study.
Exclusion Criteria:
* Suffering from severe systemic diseases (such as congenital heart disease, blood disorders, immune deficiencies, etc.);
* Having congenital craniofacial deformities (such as cleft lip and palate, facial clefts, etc.);
* Undergoing orthodontic treatment for the mouth;
* Having a history of long-term use of drugs that affect saliva secretion;
* Refusing to undergo oral clinical examination or unable to cooperate.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
number of carious teeth at the baseline
Timeframe: at the baseline
2
number of carious teeth at 6 months
Timeframe: at 6 months after enrollment
3
number of carious teeth at 1 year
Timeframe: at 1 year after enrollment
Trial details
NCT IDNCT07335744
SponsorThe Children's Hospital of Zhejiang University School of Medicine