Construction of a Multidimensional Risk Prediction Model for Severe Early Childhood Caries

NCT07335744 | Not Yet Recruiting DMC

• 1 other identifier: 2026-IRB-0008-P-01
• Study Type: observational
• Target: 1,200
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Severe Early Childhood Caries; Caries

Outcome Measures

Primary Outcomes (3)

• number of carious teeth at the baseline

  The number of the carious teeth includes the treated or untreated carious teeth.

  at the baseline

• number of carious teeth at 6 months

  The number of carious includes treated or untreated carious teeth.

  at 6 months after enrollment

• number of carious teeth at 1 year

  the number of carious teeth includes treated or untreated carious teeth.

  at 1 year after enrollment

Interventions

questionnaire survey OTHER

Parents fill out the "Children's Oral Health and Comprehensive Development Assessment Form", which includes scales such as family socioeconomic status, parental burnout in child-rearing (PBA), children's executive function (BRIEF-P), sleep habits (CSHQ), and dental fear (CFSS-DS).

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children who visited the oral department of the Children's Hospital affiliated to Zhejiang University School of Medicine.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Children's Hospital of Zhejiang University School of Medicine: lead

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: attending doctor

Study Record Dates

• First Submitted: December 24, 2025
• First Posted: January 13, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): May 30, 2028
• Last Updated: February 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share