Three Measures for the Prevention of Carious Lesions in Preschool Children

Study Overview
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Brief Summary
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Analysis different measures preventive effect on carious Lesions incidence and oral microecological system change of preschool children

Detailed Description
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Different caries prevention trials including fluoride vanish, IgY-passive immunotherapy and probiotics lasting 24 months were conducted with a total of 500 children aged 24 to 54 months of age in Lin'an, Zhejiang, China. The trials were cluster- domized .After obtaining parent´s informed consent, preschool children were clinical examinated according to ICDAS-Ⅱ and microbiological tested of saliva at baseline, 1m, 6m, 12m, 18m and 24m. To find the differences of caries incidence and oral microecology change in four groups, dmfs will be assessed and saliva will be analysed in experiment.

Official Title
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Study on Children's Dental Caries Prevention and Mechanism

Conditions
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Dental Caries

Intervention / Treatment
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* Drug: fluoride varnish
* Biological: Immunoglobulin Yolk
* Dietary Supplement: Probiotics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: preschool children in good general health At least 18 deciduous teeth Exclusion Criteria: With major systemic disease or on long-term medication Not cooperative and refuse dental treatment With a history of extra fluoride supplement Take antibiotics for nearly 8 weeks

Ages Eligible for Study
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Minimum Age: 24 Months
Maximum Age: 54 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Only behavioral education for Caregiver | |
| Experimental: fluoride varnish<br>fluoride varnish every 6 months | Drug: fluoride varnish<br>* Sodium fluoride 50mg/ml<br>* Other names: Duraphat(Colgate-palmolive company);|
| Experimental: ImmunoglobulinY<br>anti-S.mutans Immunoglobulin yolk for everyday use | Biological: Immunoglobulin Yolk<br>* anti-Streptococcus mutans IgY<br>* Other names: Aoliding oral bacteriostatic spray(Hangzhou YaSheng Biotech);|
| Experimental: Probiotics<br>Probiotics use for 1 months | Dietary Supplement: Probiotics<br>* 2g/day，Lactobacillus rhamnosus HN001, Bifidobacterium lactis Bi-07, Bifidobacterium lactis HN019, maltodextrin, fructose, skimmed milk powder<br>* Other names: Probiotics milk power(Minsheng Pharmaceutical);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of new cavitated or incipient carious lesion | To determine whether preschool children that only with caregiver behavior education have more new caries lesion than those taken some caries preventive measures by differences in dmfs（decay，missing，filling teeth surfaces） index after 24 months dental exams. | 24 months after first visit |