Three Measures for the Prevention of Carious Lesions in Preschool Children

Study on Children's Dental Caries Prevention and Mechanism

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02341352

Enrollment

500

Registered

2015-01-19

Start date

2013-04-30

Completion date

2015-06-30

Last updated

2015-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries

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.

Interventions

DRUGfluoride varnish

Sodium fluoride 50mg/ml

BIOLOGICALImmunoglobulin Yolk

anti-Streptococcus mutans IgY

DIETARY_SUPPLEMENTProbiotics

2g/day，Lactobacillus rhamnosus HN001, Bifidobacterium lactis Bi-07, Bifidobacterium lactis HN019, maltodextrin, fructose, skimmed milk powder

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

24 Months to 54 Months

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026