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Anticaries Effect of Probiotic Lactobacillus Brevis CD2 (Lb CD2).

NCT01778699 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 440

Last updated 2014-02-20

No results posted yet for this study

Summary

In a previous study the efficacy of Lb CD2 on interim covariates related to caries development was tested. So, it was decided to plan a new study on schoolchildren from the same area. The aim of the present research protocol was to evaluate the anticariogenic effect of probiotics daily used, on the caries development in children. The null hypothesis was that the probiotic Lb CD2 would not modify the caries risk of the children. Moreover, the study will be carried out to investigate the plaque acidogenicity in situ following the regular consumption of a probiotic product compared to a control group.

Objective: To determine the effect of a regularly consumed probiotic on the development of new caries lesions.

Study design: Double blind, placebo-controlled, longitudinal study, monocentric, national, in situ

Conditions

  • Dental Caries
  • Gingivitis

Interventions

DIETARY_SUPPLEMENT

lozenges

The test products for the study is manufactured and provided by CD Investments srl, Italy. The placebo lozenges will look like the active lozenges with the same taste and weight of 1 gram containing only the ingredients listed above in the same proportion as the active but with no L. brevis CD2. It will not be possible to differentiate the two products. The study center and the monitor must be informed of any deficiency in the study products (products will be kept at 4° degrees during the study).

Sponsors & Collaborators

  • University of Milan

    collaborator OTHER

  • Göteborg University

    collaborator OTHER

  • Università degli Studi di Sassari

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
7 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2015-03-31
Completion
2015-04-30

Countries

  • Italy

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 NCT01778699 on ClinicalTrials.gov