Overview

This trial is active, not recruiting.

Condition dental caries
Treatments fluoride varnish, immunoglobulin yolk, probiotics
Phase phase 3
Sponsor Zhejiang University
Collaborator Hangzhou Occupational Disease Prevention Hospital
Start date April 2013
End date April 2015
Trial size 500 participants
Trial identifier NCT02341352, 20120633B14, 2013-8, 81371142

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (investigator, outcomes assessor)
Primary purpose health services research
Arm
(No Intervention)
Only behavioral education for Caregiver
(Experimental)
fluoride varnish every 6 months
fluoride varnish Duraphat(Colgate-palmolive company)
Sodium fluoride 50mg/ml
(Experimental)
anti-S.mutans Immunoglobulin yolk for everyday use
immunoglobulin yolk Aoliding oral bacteriostatic spray(Hangzhou YaSheng Biotech)
anti—Streptococcus mutans IgY
(Experimental)
Probiotics use for 1 months
probiotics Probiotics milk power(Minsheng Pharmaceutical)
2g/day,Lactobacillus rhamnosus HN001, Bifidobacterium lactis Bi-07, Bifidobacterium lactis HN019, maltodextrin, fructose, skimmed milk powder

Primary Outcomes

Measure
The number of new cavitated or incipient carious lesion
time frame: 24 months after first visit

Eligibility Criteria

Male or female participants from 24 months up to 54 months old.

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

Additional Information

Official title Study on Children's Dental Caries Prevention and Mechanism
Principal investigator Hui Chen
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2015.
Information provided to ClinicalTrials.gov by Zhejiang University.