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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental subgroup of Cariostat | Experimental | 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. |
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| Experimental subgroup of Cariogram | Experimental | 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. |
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| Control group | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comprehensive prevention and treatment | Combination Product | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Decay teeth,Missed teeth and filled teeth (DMFT) and the change between different time points. | 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. | Baseline, one year follow up and two year follow up. |
| Measure | Description | Time Frame |
|---|---|---|
| Caries prevalence and the change between different time points. | The proportion of population with caries in the whole participants. | Baseline, one year follow up and two year follow up. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Menglin Cheng, Doctor | Contact | 80838416 | chengmenglin2011@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Menglin Cheng, Doctor | Beijing Friendship Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Friendship Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | 10000 | China |
The study protocol, statistical analysis plan, informed consent form and clinical study report are to be shared with other researchers.
When the two years follow up is completed and the result and conclusion of the study is published, the data will become available for half a year.
The sharing criteria in this study is to the research leader who register study with key words of Caries Risk Assessment on the Clinical Trail.
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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After the data is entered, the analyst is analyzed under the premise of uninformed, and the packet is performed after all analyzes are completed.
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| Routine prevention | Combination Product | Routine prevention includes fluoride foam application twice a year and oral hygiene guidance. |
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