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NCT01738958 Clinical Trial

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

Caries Dentalis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01738958
Other study ID # H-4-2012-096
Secondary ID
Status Completed
Phase N/A
First received November 28, 2012
Last updated December 2, 2014
Start date September 2012
Est. completion date March 2014

Study information
Verified date December 2014
Source University of Copenhagen
Contact n/a
Is FDA regulated No
Health authority Denmark: The Danish National Committee on Biomedical Research Ethics
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 66
Est. completion date March 2014
Est. primary completion date July 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 12 Years to 17 Years
Eligibility Inclusion Criteria:

- two sites with white spot lesions in anterior teeth

Exclusion Criteria:

- antibiotic treatment within 2 months

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Biological:
• L. retueri
two tablets a day for 6 weeks
• Placebo

Locations
Country Name City State
Denmark Ishøj kommunale tandpleje Ishøj

Sponsors (1)
Lead Sponsor Collaborator
University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in enamel porosity Change in enamel porosity assed by QLF Baseine and 12 weeks No