Three Measures for the Prevention of Carious Lesions in Preschool Children

January 13, 2015 updated by: Xi Chen, Zhejiang University

Study on Children's Dental Caries Prevention and Mechanism

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310006
        • Affiliated Hospital of Stomatology, School of Medicine, Zhejiang University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 4 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 months after first visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang University

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Anticipated)

April 1, 2015

Study Completion (Anticipated)

June 1, 2015

Study Registration Dates

First Submitted

January 8, 2015

First Submitted That Met QC Criteria

January 13, 2015

First Posted (Estimate)

January 19, 2015

Study Record Updates

Last Update Posted (Estimate)

January 19, 2015

Last Update Submitted That Met QC Criteria

January 13, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

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)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dental Caries

Clinical Trials on fluoride varnish

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Luxembourg

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe