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Three Measures for the Prevention of Carious Lesions in Preschool Children

Primary Purpose

Dental Caries

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
fluoride varnish
Immunoglobulin Yolk
Probiotics
Sponsored by
Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Dental Caries

Eligibility Criteria

24 Months - 54 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Affiliated Hospital of Stomatology, School of Medicine, Zhejiang University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

Control

fluoride varnish

ImmunoglobulinY

Probiotics

Arm Description

Only behavioral education for Caregiver

fluoride varnish every 6 months

anti-S.mutans Immunoglobulin yolk for everyday use

Probiotics use for 1 months

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 8, 2015
Last Updated
January 13, 2015
Sponsor
Zhejiang University
Collaborators
Hangzhou Occupational Disease Prevention Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02341352
Brief Title
Three Measures for the Prevention of Carious Lesions in Preschool Children
Official Title
Study on Children's Dental Caries Prevention and Mechanism
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Unknown status
Study Start Date
April 2013 (undefined)
Primary Completion Date
April 2015 (Anticipated)
Study Completion Date
June 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhejiang University
Collaborators
Hangzhou Occupational Disease Prevention Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Only behavioral education for Caregiver
Arm Title
fluoride varnish
Arm Type
Experimental
Arm Description
fluoride varnish every 6 months
Arm Title
ImmunoglobulinY
Arm Type
Experimental
Arm Description
anti-S.mutans Immunoglobulin yolk for everyday use
Arm Title
Probiotics
Arm Type
Experimental
Arm Description
Probiotics use for 1 months
Intervention Type
Drug
Intervention Name(s)
fluoride varnish
Other Intervention Name(s)
Duraphat(Colgate-palmolive company)
Intervention Description
Sodium fluoride 50mg/ml
Intervention Type
Biological
Intervention Name(s)
Immunoglobulin Yolk
Other Intervention Name(s)
Aoliding oral bacteriostatic spray(Hangzhou YaSheng Biotech)
Intervention Description
anti-Streptococcus mutans IgY
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotics
Other Intervention Name(s)
Probiotics milk power(Minsheng Pharmaceutical)
Intervention Description
2g/day，Lactobacillus rhamnosus HN001, Bifidobacterium lactis Bi-07, Bifidobacterium lactis HN019, maltodextrin, fructose, skimmed milk powder
Primary Outcome Measure Information:
Title
The number of new cavitated or incipient carious lesion
Description
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.
Time Frame
24 months after first visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Months
Maximum Age & Unit of Time
54 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui Chen
Organizational Affiliation
Department of Conservative Dentistry and Periodontics, Affiliated Hospital of Stomatology, School of Medicine, Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Affiliated Hospital of Stomatology, School of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310006
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
33381248
Citation
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.
Results Reference
derived
PubMed Identifier
31690590
Citation
Wang 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.
Results Reference
derived

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Three Measures for the Prevention of Carious Lesions in Preschool Children

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