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NCT02341352 Clinical Trial

Three Measures for the Prevention of Carious Lesions in Preschool Children

Dental Caries Clinical Trial

Official title:
Study on Children's Dental Caries Prevention and Mechanism

Clinical Trial Details — Status: Unknown status

Administrative data
NCT number NCT02341352
Other study ID # 2013-8
Secondary ID 8137114220120633
Status Unknown status
Phase Phase 3
First received January 8, 2015
Last updated January 13, 2015
Start date April 2013
Est. completion date June 2015

Study information
Verified date January 2015
Source Zhejiang University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Unknown status
Enrollment 500
Est. completion date June 2015
Est. primary completion date April 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 24 Months to 54 Months
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
China Affiliated Hospital of Stomatology, School of Medicine, Zhejiang University Hangzhou Zhejiang

Sponsors (2)
Lead Sponsor Collaborator
Zhejiang University Hangzhou Occupational Disease Prevention Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary The number of new cavitated or incipient carious lesion 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. 24 months after first visit
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