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Clinical Analysis of a Risk-graded and Comprehensive Intervention for Early-childhood-caries

NCT05260216 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2022-07-21

No results posted yet for this study

Summary

Cariogram and Cariostat will be used to assess the risk of caries in kindergarten children aged 3 years. Routine preventive measures will be taken for children at low risk of caries, and intensive intervention measures will be taken for children at medium and high risk. Routine measures will be taken for the control group. After one and two year, the prevalence of caries in the experimental group and the control group should be evaluated, and the cost-effectiveness evaluation will be conducted.

Conditions

  • Early Childhood Caries

Interventions

COMBINATION_PRODUCT

Comprehensive prevention and treatment

Children with low risk of caries will receive routine prevention including fluoride foam application twice a year and oral hygiene guidance. Children with middle or high risk of caries will receive fluoride varnish application twice a year and caries restorative treatment in addition to routine prevention. The risk-graded intervention is one kind of comprehensive prevention and treatment.

COMBINATION_PRODUCT

Routine prevention

Routine prevention includes fluoride foam application twice a year and oral hygiene guidance.

Sponsors & Collaborators

  • Beijing Friendship Hospital

    lead OTHER

Principal Investigators

  • Menglin Cheng, Doctor · Beijing Friendship Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
4 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-04
Primary Completion
2022-08-31
Completion
2024-08-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05260216 on ClinicalTrials.gov