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Trial record 14 of 1236 for:    tooth decay

Three Measures for the Prevention of Carious Lesions in Preschool Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02341352
Recruitment Status : Unknown
Verified January 2015 by Xi Chen, Zhejiang University.
Recruitment status was:  Active, not recruiting
First Posted : January 19, 2015
Last Update Posted : January 19, 2015
Hangzhou Occupational Disease Prevention Hospital
Information provided by (Responsible Party):
Xi Chen, Zhejiang University

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 2013
Estimated Primary Completion Date : April 2015
Estimated Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Fluoride

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 Name: Duraphat(Colgate-palmolive company)

Experimental: ImmunoglobulinY
anti-S.mutans Immunoglobulin yolk for everyday use
Biological: Immunoglobulin Yolk
anti—Streptococcus mutans IgY
Other Name: 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 Name: Probiotics milk power(Minsheng Pharmaceutical)

Primary Outcome Measures :
  1. The number of new cavitated or incipient carious lesion [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   24 Months to 54 Months   (Child)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02341352

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China, Zhejiang
Affiliated Hospital of Stomatology, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310006
Sponsors and Collaborators
Zhejiang University
Hangzhou Occupational Disease Prevention Hospital
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Principal Investigator: Hui Chen Department of Conservative Dentistry and Periodontics, Affiliated Hospital of Stomatology, School of Medicine, Zhejiang University

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Responsible Party: Xi Chen, Master, Zhejiang University Identifier: NCT02341352     History of Changes
Other Study ID Numbers: 2013-8
81371142 ( Other Grant/Funding Number: National Natural Science Foundation of China )
20120633B14 ( Other Grant/Funding Number: Hangzhou Science and Technology Project )
First Posted: January 19, 2015    Key Record Dates
Last Update Posted: January 19, 2015
Last Verified: January 2015
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Fluorides, Topical
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Immunologic Factors