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Severe Early Childhood CariesNCT07335744

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

An observational study of Severe Early Childhood Caries and Caries, run by The Children's Hospital of Zhejiang University School of Medicine.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial 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". Read more about this study

Who is it for?
Ages 3 to 6 yearsHealthy volunteers can take part
Conditions the study is for
Severe Early Childhood Caries, Caries
What is being tested?
questionnaire survey
Type of treatment
Pill or oral medicine
How many people
1,200 participants
Where
No sites listed yet
Study dates
1 Mar 2026to 30 May 2028
Phase
Observational
Are there results?
Not yet: the study is under way

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 3 to 6 years
  • All sexes
  • Healthy volunteers accepted
  • Child

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

Who may be able to join

  • 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.

Who cannot join

  • 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.

About this study

Official title: Construction of a Multidimensional Risk Prediction Model for Severe Early Childhood Caries Based on the "Bio-psy-social" Medical Model

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.

Read the detailed description

Severe Early Childhood Caries (S-ECC), as a serious infectious disease that severely endangers the physical and mental health of preschool children, has now become a major public health challenge in pediatric dentistry in China. Epidemiological data show that the prevalence of caries among 3-5-year-old children in China remains high, and it is characterized by rapid disease progression, extensive tooth surface involvement, and high treatment difficulty. S-ECC not only leads to extensive tooth tissue loss in children, causing severe pain due to pulpitis and periapical inflammation, but also seriously affects children's masticatory efficiency, facial growth and development, language function, and sleep quality, and may even induce systemic diseases due to long-term chronic inflammation. Although current clinical treatment methods cover fluoride application, minimally invasive restoration, and comprehensive treatment under general anesthesia, high postoperative recurrence rates and difficult behavioral management are common problems in clinical practice. This reveals the limitations of the current "biomedical model" dominated diagnosis and treatment system, which focuses on the repair of dental lesions but neglects the deep-seated family behavioral and psychosocial roots that cause the disease and its recurrence.

Previous research on the etiology of S-ECC mainly focused on biological aspects such as cariogenic bacteria (such as Streptococcus mutans), host factors (such as saliva composition and tooth structure), and environmental factors (such as sugar intake frequency) . With the deepening of research, although some scholars have begun to pay attention to the impact of socioeconomic status (SES) on oral health, finding that parents' educational level and family income are significantly related to the caries rate, these macroscopic sociodemographic indicators are difficult to explain why there are significant differences in oral health management capabilities among families with similar socioeconomic backgrounds . The current knowledge gap lies in the lack of analysis of the family aggregation mechanism of S-ECC from the perspective of micro psychology and behavioral neuroscience. In particular, the concept of "parental burnout" proposed in the field of psychology in recent years, which refers to the emotional exhaustion and reduced parental efficacy that parents experience under long-term parenting stress, may lead to the lack or ineffectiveness of their supervision over children's oral hygiene behaviors, but this has not been fully verified in the field of dentistry . At the same time, previous studies often viewed dietary habits in isolation and ignored the "24-hour activity behavior" holistic view proposed by the World Health Organization, that is, there may be complex interactions between sleep disorders (such as mouth breathing, night waking), sedentary behavior (excessive screen time), and unhealthy diet, which together form a risk loop for S-ECC. In addition, the cognitive traits of preschool children themselves, such as deficits in inhibitory control in executive function, may lead to poor cooperation in tooth brushing and poor control of dietary impulses, and the impact of this neuro-psychological characteristic on the susceptibility to S-ECC is also a blind spot in current research.

Given the above background and research status, it is particularly urgent and important to conduct multi-dimensional risk factor research on S-ECC in preschool children based on the "biopsychosocial" medical model. This study aims to break through the framework of traditional etiological research, and on the basis of collecting objective clinical indicators such as the dmft index and plaque index, introduce psychological and behavioral science assessment tools to systematically explore the deep association pathways between parental burnout, children's executive function deficits, and unhealthy lifestyles (sleep, screen time) and the onset of S-ECC. This study not only helps to fill the current knowledge gap regarding the psychosocial pathogenesis of S-ECC and explain the phenomenon that "high-knowledge families" may still have a high risk of caries, but also has important clinical translation significance. By constructing a multi-dimensional risk prediction model of S-ECC that incorporates psychological and behavioral characteristics, clinicians can identify families with "high-risk psychological and behavioral characteristics" at an early stage, thereby moving the intervention point forward and achieving a shift from merely "tooth treatment" to "overall oral health management of the family". This provides a solid evidence-based medical basis for formulating precise personalized prevention strategies and reducing the recurrence rate of S-ECC.

Being tested
questionnaire survey

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • questionnaire surveyOther

    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).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. number of carious teeth at the baseline

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

    Measured: at the baseline

  2. number of carious teeth at 6 months

    The number of carious includes treated or untreated carious teeth.

    Measured: at 6 months after enrollment

  3. number of carious teeth at 1 year

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

    Measured: at 1 year after enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2026
  2. Study start1 Mar 2026 (estimated)
  3. Primary completion30 May 2027 (estimated)
  4. Study completion30 May 2028 (estimated)

Resources

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
1,200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07335744
Sponsor's protocol ID
2026-IRB-0008-P-01
Status last verified
Jan 2026
First submitted
24 Dec 2025
Last updated
12 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Severe Early Childhood Caries and Caries, run by The Children's Hospital of Zhejiang University School of Medicine.

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 3 inclusion and 5 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: opening soon, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

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?

number of carious teeth at the baseline (time frame: at the baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 12 Feb 2026.

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