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Effect of Lozenges Containing Probiotic Lactobacilli on Enamel Demineralization Assed by QLF

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ClinicalTrials.gov Identifier: NCT01738958
Recruitment Status : Completed
First Posted : November 30, 2012
Last Update Posted : December 3, 2014
Sponsor:
Information provided by (Responsible Party):
Mette Kirstine Keller, University of Copenhagen

Brief Summary:

Clinical trials in children and adults have suggested that daily consumption of probiotic lactic acid bacteria can reduce caries risk and caries development in primary teeth in preschool and stop root caries in the elderly. However, it is not known whether probiotic bacteria can affect the increased porosity in young permanent teeth in children and adolescents with many cavities.

It can be difficult to measure the increased porosity of the enamel by tooth decay, but this can be done using quantitative laser fluorescence (QLF). The method is based on visible light with a wavelength of 370 nm, addressing enamel. This produces an image consisting of red and green color tones and the dominant color of the enamel is green. Increased porosity of the enamel, resulting in a reduction of the auto-fluorescence and the loss (or gain) of the mineral can be quantified by means of a corresponding software.

The purpose of this study is to investigate the effect of a daily supplement of probiotic lactic acid bacteria on the loss of mineral in enamel assessed with QLF. The null hypothesis is that the mineral content will not differ from baseline in either the test group or the placebo group.


Condition or disease Intervention/treatment Phase
Caries Dentalis Biological: L. retueri Biological: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Lozenges Containing Probiotic Lactobacilli on Enamel Demineralization Assed by QLF
Study Start Date : September 2012
Actual Primary Completion Date : July 2013
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Probiotic lactobacilli
L. reuteri, two times a day for 6 weeks
Biological: L. retueri
two tablets a day for 6 weeks
Placebo Comparator: Placebo
Placebo tablets, two times a day for 6 weeks
Biological: Placebo



Primary Outcome Measures :
  1. Change in enamel porosity [ Time Frame: Baseine and 12 weeks ]
    Change in enamel porosity assed by QLF



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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • two sites with white spot lesions in anterior teeth

Exclusion Criteria:

  • antibiotic treatment within 2 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01738958


Locations
Denmark
Ishøj kommunale tandpleje
Ishøj, Denmark, 2635
Sponsors and Collaborators
University of Copenhagen

Responsible Party: Mette Kirstine Keller, Assistant Professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01738958     History of Changes
Other Study ID Numbers: H-4-2012-096
First Posted: November 30, 2012    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: December 2014

Keywords provided by Mette Kirstine Keller, University of Copenhagen:
Probiotic bacteria
Caries dentalis
QLF