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

Not Applicable

Recruiting

• Conditions: Early Childhood Caries
• Interventions: Combination Product: Comprehensive prevention and treatment; Combination Product: Routine prevention

• Registration Number: NCT05260216
• Lead Sponsor: Beijing Friendship Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2021-11-04
• Status Verified: 2021-12
• Study First Submitted: 2021-12-12
• Study First Submitted QC: 2022-02-24
• Study First Posted: 2022-03-02
• Last Update Submitted: 2022-07-19
• Last Update Posted: 2022-07-21
• Primary Completion: 2022-08-31
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 480

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental subgroup of Cariostat	Comprehensive prevention and treatment	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.
Control group	Routine prevention	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.
Experimental subgroup of Cariogram	Comprehensive prevention and treatment	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.

Primary Outcome Measures

Name	Time	Method
Decay teeth,Missed teeth and filled teeth (DMFT) and the change between different time points.	Baseline, one year follow up and two year follow up.	The average value of the sum of the number of decayed teeth, the number of filled teeth, and the number of missed teeth due to caries.

Secondary Outcome Measures

Name	Time	Method
Caries prevalence and the change between different time points.	Baseline, one year follow up and two year follow up.	The proportion of population with caries in the whole participants.

Trial Locations

Locations (1)

Beijing Friendship Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China