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
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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 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Probiotic lactobacilli
L. reuteri, two times a day for 6 weeks
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Biological: L. retueri
two tablets a day for 6 weeks |
Placebo Comparator: Placebo
Placebo tablets, two times a day for 6 weeks
|
Biological: Placebo |
- 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 |
Inclusion Criteria:
- two sites with white spot lesions in anterior teeth
Exclusion Criteria:
- antibiotic treatment within 2 months

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
Denmark | |
Ishøj kommunale tandpleje | |
Ishøj, Denmark, 2635 |
Responsible Party: | Mette Kirstine Keller, Assistant Professor, University of Copenhagen |
ClinicalTrials.gov Identifier: | NCT01738958 |
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 |
Probiotic bacteria Caries dentalis QLF |