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Effect of 12 Months Supplementation With a Symbiotic Lozenge on Caries Increment in Healthy Children

NCT03928587 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 343

Last updated 2022-10-03

No results posted yet for this study

Summary

The primary objective of this trial is to investigate the effect of a symbiotic lozenge on dental caries in young children.

Conditions

  • Dental Caries

Interventions

DIETARY_SUPPLEMENT

2 billion CFU in total of the two strains Lactobacillus paracasei subsp. paracasei and Lactobacillus rhamnosus and arginine.

One lozenge once daily for 12 months

DIETARY_SUPPLEMENT

Placebo

Placebo once daily for 12 months

Sponsors & Collaborators

  • University of Copenhagen

    collaborator OTHER

  • Chr Hansen

    lead INDUSTRY

Principal Investigators

  • Azam Bakhshandeh, PhD · University of Copenhagen

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-01
Primary Completion
2021-10-08
Completion
2021-10-08

Countries

  • Denmark

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 NCT03928587 on ClinicalTrials.gov