Three Measures for the Prevention of Carious Lesions in Preschool Children

Zhejiang University

Status and phase: Unknown; Phase 3

Conditions: Dental Caries

Treatments: Dietary Supplement: Probiotics; Drug: fluoride varnish; Biological: Immunoglobulin Yolk

Study type: Interventional

Funder types: Other

Identifiers

NCT02341352

2013-8

81371142 (Other Grant/Funding Number)

20120633B14 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full description

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 24 to 54 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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500 participants in 4 patient groups

Control

No Intervention group

Description:

Only behavioral education for Caregiver

fluoride varnish

Experimental group

Description:

fluoride varnish every 6 months

Treatment:

Drug: fluoride varnish

ImmunoglobulinY

Experimental group

Description:

anti-S.mutans Immunoglobulin yolk for everyday use

Treatment:

Biological: Immunoglobulin Yolk

Probiotics

Experimental group

Description:

Probiotics use for 1 months

Treatment:

Dietary Supplement: Probiotics