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OpenTrials
Completed

NCT Number: NCT01738958

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

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.

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Key information

Conditions

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ishøj kommunale tandpleje

Ishøj, 2635, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • two sites with white spot lesions in anterior teeth

Exclusion criteria

  • antibiotic treatment within 2 months

Treatment and study plan

L. retueri

Biological

two tablets a day for 6 weeks

Placebo

Biological

Primary outcomes

  1. Change in enamel porosity

    Time frame: Baseine and 12 weeks

    Change in enamel porosity assed by QLF

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Nov 30, 2012
Registry last updated
Dec 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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