Three Measures for the Prevention of Carious Lesions in Preschool Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2015-06-30

Brief Summary

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

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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.

Conditions

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Dental Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Control

Only behavioral education for Caregiver

Group Type NO_INTERVENTION

No interventions assigned to this group

fluoride varnish

fluoride varnish every 6 months

Group Type EXPERIMENTAL

fluoride varnish

Intervention Type DRUG

Sodium fluoride 50mg/ml

ImmunoglobulinY

anti-S.mutans Immunoglobulin yolk for everyday use

Group Type EXPERIMENTAL

Immunoglobulin Yolk

Intervention Type BIOLOGICAL

anti-Streptococcus mutans IgY

Probiotics

Probiotics use for 1 months

Group Type EXPERIMENTAL

Probiotics

Intervention Type DIETARY_SUPPLEMENT

2g/day，Lactobacillus rhamnosus HN001, Bifidobacterium lactis Bi-07, Bifidobacterium lactis HN019, maltodextrin, fructose, skimmed milk powder

Interventions

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fluoride varnish

Sodium fluoride 50mg/ml

Intervention Type DRUG

Immunoglobulin Yolk

anti-Streptococcus mutans IgY

Intervention Type BIOLOGICAL

Probiotics

2g/day，Lactobacillus rhamnosus HN001, Bifidobacterium lactis Bi-07, Bifidobacterium lactis HN019, maltodextrin, fructose, skimmed milk powder

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Duraphat(Colgate-palmolive company) Aoliding oral bacteriostatic spray(Hangzhou YaSheng Biotech) Probiotics milk power(Minsheng Pharmaceutical)

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

Minimum Eligible Age

24 Months

Maximum Eligible Age

54 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes