Three Measures for the Prevention of Carious Lesions in Preschool Children

Sponsor

Zhejiang University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02341352

Collaborator

Hangzhou Occupational Disease Prevention Hospital (Other)

500

Enrollment

Location

Arms

Duration (Months)

19.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Dental Caries	Drug: fluoride varnish Biological: Immunoglobulin Yolk Dietary Supplement: Probiotics	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

500 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Health Services Research

Official Title:

Study on Children's Dental Caries Prevention and Mechanism

Study Start Date :

Apr 1, 2013

Anticipated Primary Completion Date :

Apr 1, 2015

Anticipated Study Completion Date :

Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control Only behavioral education for Caregiver
Experimental: fluoride varnish fluoride varnish every 6 months	Drug: fluoride varnish Sodium fluoride 50mg/ml Other Names: Duraphat(Colgate-palmolive company)
Experimental: ImmunoglobulinY anti-S.mutans Immunoglobulin yolk for everyday use	Biological: Immunoglobulin Yolk anti-Streptococcus mutans IgY Other Names: Aoliding oral bacteriostatic spray(Hangzhou YaSheng Biotech)
Experimental: Probiotics Probiotics use for 1 months	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)

Outcome Measures

Primary Outcome Measures

The number of new cavitated or incipient carious lesion [24 months after first visit]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

24 Months to 54 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Affiliated Hospital of Stomatology, School of Medicine, Zhejiang University	Hangzhou	Zhejiang	China	310006

Sponsors and Collaborators

Zhejiang University
Hangzhou Occupational Disease Prevention Hospital

Investigators

Principal Investigator: Hui Chen, Department of Conservative Dentistry and Periodontics, Affiliated Hospital of Stomatology, School of Medicine, Zhejiang University