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Preventive Effect of a Probiotic Tablet on Oral Health in Preschool Children

NCT01720771 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2015-05-29

No results posted yet for this study

Summary

The aim of the prospective project is to investigate effect of daily probiotic supplements on dental caries development in preschool children living in a low socioeconomic immigrant area in souithern Sweden. The study design is a randomised controlled trial with two parallell arms. The intervention is one probiotic tablet or placebo once daily. The null hypothesis is that the caries experience and increment will not differ betwwen the two groups.

Conditions

  • Dental Caries

Interventions

DIETARY_SUPPLEMENT

probiotic tablet

Intake of one probiotic lozenge tablet per day

DIETARY_SUPPLEMENT

sugar pill

one tablet daily

Sponsors & Collaborators

  • University of Copenhagen

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
3 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2014-12-31
Completion
2015-05-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01720771 on ClinicalTrials.gov