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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE November 28, 2012
First Posted Date  ICMJE November 30, 2012
Last Update Posted Date December 3, 2014
Study Start Date  ICMJE September 2012
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 29, 2012)
Change in enamel porosity [ Time Frame: Baseine and 12 weeks ]
Change in enamel porosity assed by QLF
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Lozenges Containing Probiotic Lactobacilli on Enamel Demineralization Assed by QLF
Official Title  ICMJE Effect of Lozenges Containing Probiotic Lactobacilli on Enamel Demineralization Assed by QLF
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Caries Dentalis
Intervention  ICMJE
  • Biological: L. retueri
    two tablets a day for 6 weeks
  • Biological: Placebo
Study Arms  ICMJE
  • Active Comparator: Probiotic lactobacilli
    L. reuteri, two times a day for 6 weeks
    Intervention: Biological: L. retueri
  • Placebo Comparator: Placebo
    Placebo tablets, two times a day for 6 weeks
    Intervention: Biological: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 29, 2012)
66
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • two sites with white spot lesions in anterior teeth

Exclusion Criteria:

  • antibiotic treatment within 2 months
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01738958
Other Study ID Numbers  ICMJE H-4-2012-096
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mette Kirstine Keller, University of Copenhagen
Study Sponsor  ICMJE University of Copenhagen
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Copenhagen
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP