NCT02341352

Three Measures for the Prevention of Carious Lesions in Preschool Children

Study on Children's Dental Caries Prevention and Mechanism

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Zhejiang University · Academic / Other
• Sex: All
• Age: 24 Months – 54 Months
• Healthy volunteers: Accepted

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.

Conditions

• Dental Caries

Interventions

Type	Name	Description
DRUG	fluoride varnish	Sodium fluoride 50mg/ml
BIOLOGICAL	Immunoglobulin Yolk	anti-Streptococcus mutans IgY
DIETARY_SUPPLEMENT	Probiotics	2g/day，Lactobacillus rhamnosus HN001, Bifidobacterium lactis Bi-07, Bifidobacterium lactis HN019, maltodextrin, fructose, skimmed milk powder

Timeline

• Start date: 2013-04-01
• Primary completion: 2015-04-01
• Completion: 2015-06-01
• First posted: 2015-01-19
• Last updated: 2015-01-19

Locations

1 site across 1 country: China