Trial | NCT02341352  Report issue

Title

Three Measures for the Prevention of Carious Lesions in Preschool Children
Study on Children's Dental Caries Prevention and Mechanism

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    500
Analysis different measures preventive effect on carious Lesions incidence and oral microecological system change of preschool children
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 Started
Apr 30
2013
Primary Completion
Apr 30
2015
Anticipated
Study Completion
Jun 30
2015
Anticipated
Last Update
Jan 19
2015
Estimate

Drug fluoride varnish

Sodium fluoride 50mg/ml

  • Other names: Duraphat(Colgate-palmolive company)

Biological Immunoglobulin Yolk

anti-Streptococcus mutans IgY

  • Other names: Aoliding oral bacteriostatic spray(Hangzhou YaSheng Biotech)

Dietary Supplement Probiotics

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

  • Other names: Probiotics milk power(Minsheng Pharmaceutical)

Control No Intervention

Only behavioral education for Caregiver

fluoride varnish Experimental

fluoride varnish every 6 months

ImmunoglobulinY Experimental

anti-S.mutans Immunoglobulin yolk for everyday use

Probiotics Experimental

Probiotics use for 1 months

Criteria 

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
No Results Posted