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

Capital Medical University

Status: Enrolling

Conditions: Early Childhood Caries

Treatments: Combination Product: Comprehensive prevention and treatment; Combination Product: Routine prevention

Study type: Interventional

Funder types: Other

Identifiers

NCT05260216

CARGACIFECC

Details and patient eligibility

About

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.

Full description

Caries risk-graded intervention for preschool children is needed as different child has different risk to suffer from caries.

Cariogram and Cariostat are two different and common caries risk assessment tools. Cariogram is a complicated but economical computer program which is more sensitive for caries risk assessment. Cariostat is a biological reagents with high specificity but it may be expensive to use for large numbers of children.

The experimental group will be divided into two subgroups, one use Cariogram and the other use Cariostat to assess the risk. Based on the results of the assessment, children with low risk of caries will get routine prevention including twice fluorinated foams each year and hygiene. Children with middle or high risk of caries will receive twice fluorinated varnish each year and professional caries treatment in addition to routine prevention.Routine prevention will be taken for the control group with both Cariogram and Cariostat assessment.

Follow-up will arrange one and two years after baseline recruitment. All participants will receive oral health-related questionnaires at baseline and follow-up.

The prevalence of caries in the experimental group and the control group should be evaluated, and the cost-effectiveness evaluation will be conducted.

Enrollment: 480 estimated patients

Sex: All

Ages: 3 to 4 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Junior kindergarten children who enter the kindergarten in September 2021 and can cooperate with the oral health examination.
2. Parents of children fully understand the purpose of the study, cooperate with the questionnaire survey during the study, give informed consent and sign the informed consent form.
3. The child has no serious systemic diseases, has not taken hormones and immunosuppressants within 6 months, and has no history of antibiotic use within 1 month，and is not allergic to fluoride.

Exclusion criteria

1. Parents of children refuse to provide information about children's oral health or questionnaires.
2. Children cannot cooperate with oral health examination.
3. The child has a serious systemic disease that may affect the results of the study.
4. Children who are allergic to fluoride.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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480 participants in 3 patient groups, including a placebo group

Experimental subgroup of Cariostat

Experimental group

Description:

Use Cariostat as the caries risk assessment tool to divide the children into different risk levels. Based on the results, children with low risk of caries will receive twice fluoride foam each year and oral hygiene guidance, children with middle or high risk of caries will receive forth fluoride applications each year, oral hygiene guidance and professional caries treatment.

Treatment:

Combination Product: Comprehensive prevention and treatment

Experimental subgroup of Cariogram

Experimental group

Description:

Use Cariogram as the caries risk assessment tool to divide the children into different risk levels. Based on the results, children with low risk of caries will receive twice fluoride foam each year and oral hygiene guidance, children with middle or high risk of caries will receive forth fluoride applications each year, oral hygiene guidance and professional caries treatment.

Treatment:

Combination Product: Comprehensive prevention and treatment

Control group

Placebo Comparator group

Description:

Use Cariogram and as the caries risk assessment tool to divide the children into different risk levels. All children will receive routine prevention including wice fluoride foam each year and oral hygiene guidance.

Treatment:

Combination Product: Routine prevention