Three Measures for the Prevention of Carious Lesions in Preschool Children
Study on Children's Dental Caries Prevention and Mechanism
3 other identifiers
interventional
500
1 country
1
Brief Summary
Analysis different measures preventive effect on carious Lesions incidence and oral microecological system change of preschool children
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 8, 2015
CompletedFirst Posted
Study publicly available on registry
January 19, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedJanuary 19, 2015
January 1, 2015
2 years
January 8, 2015
January 13, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (4)
Control
NO INTERVENTIONOnly behavioral education for Caregiver
fluoride varnish
EXPERIMENTALfluoride varnish every 6 months
ImmunoglobulinY
EXPERIMENTALanti-S.mutans Immunoglobulin yolk for everyday use
Probiotics
EXPERIMENTALProbiotics use for 1 months
Interventions
Sodium fluoride 50mg/ml
anti-Streptococcus mutans IgY
2g/day，Lactobacillus rhamnosus HN001, Bifidobacterium lactis Bi-07, Bifidobacterium lactis HN019, maltodextrin, fructose, skimmed milk powder
Eligibility Criteria
You may qualify if:
- preschool children in good general health
- At least 18 deciduous teeth
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Affiliated Hospital of Stomatology, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310006, China
Related Publications (2)
Zhang J, Su L, Wang Y, Deng S. Improved High-Throughput Sequencing of the Human Oral Microbiome: From Illumina to PacBio. Can J Infect Dis Med Microbiol. 2020 Dec 11;2020:6678872. doi: 10.1155/2020/6678872. eCollection 2020.
PMID: 33381248DERIVEDWang Y, Wang S, Wu C, Chen X, Duan Z, Xu Q, Jiang W, Xu L, Wang T, Su L, Wang Y, Chen Y, Zhang J, Huang Y, Tong S, Zhou C, Deng S, Qin N. Oral Microbiome Alterations Associated with Early Childhood Caries Highlight the Importance of Carbohydrate Metabolic Activities. mSystems. 2019 Nov 5;4(6):e00450-19. doi: 10.1128/mSystems.00450-19.
PMID: 31690590DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hui Chen
Department of Conservative Dentistry and Periodontics, Affiliated Hospital of Stomatology, School of Medicine, Zhejiang University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Master
Study Record Dates
First Submitted
January 8, 2015
First Posted
January 19, 2015
Study Start
April 1, 2013
Primary Completion
April 1, 2015
Study Completion
June 1, 2015
Last Updated
January 19, 2015
Record last verified: 2015-01