Three Measures for the Prevention of Carious Lesions in Preschool Children

Phase 3

• Conditions: Dental Caries
• Interventions: Drug: fluoride varnish; Dietary Supplement: Probiotics; Biological: Immunoglobulin Yolk

• Registration Number: NCT02341352
• Lead Sponsor: Zhejiang University

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2013-04
• Status Verified: 2015-01
• Study First Submitted: 2015-01-08
• Study First Submitted QC: 2015-01-13
• Last Update Submitted: 2015-01-13
• Study First Posted: 2015-01-19
• Last Update Posted: 2015-01-19
• Primary Completion: 2015-04
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
fluoride varnish	fluoride varnish	fluoride varnish every 6 months
Probiotics	Probiotics	Probiotics use for 1 months
ImmunoglobulinY	Immunoglobulin Yolk	anti-S.mutans Immunoglobulin yolk for everyday use

Primary Outcome Measures

Name	Time	Method
The number of new cavitated or incipient carious lesion	24 months after first visit	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.

Trial Locations

Locations (1)

Affiliated Hospital of Stomatology, School of Medicine, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China