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

This study is currently recruiting participants.
Verified November 2012 by University of Copenhagen
Sponsor:
Information provided by (Responsible Party):
Mette Kirstine Keller, University of Copenhagen
ClinicalTrials.gov Identifier:
NCT01738958
First received: November 28, 2012
Last updated: November 29, 2012
Last verified: November 2012
  Purpose

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 Intervention
Caries Dentalis
Biological: L. retueri
Biological: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Lozenges Containing Probiotic Lactobacilli on Enamel Demineralization Assed by QLF

Resource links provided by NLM:


Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • Change in enamel porosity [ Time Frame: Baseine and 12 weeks ] [ Designated as safety issue: No ]
    Change in enamel porosity assed by QLF


Estimated Enrollment: 66
Study Start Date: September 2012
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • two sites with white spot lesions in anterior teeth

Exclusion Criteria:

  • antibiotic treatment within 2 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01738958

Contacts
Contact: Ida Nøhr, Dentist 43734997 YIL@ishoj.dk

Locations
Denmark
Ishøj kommunale tandpleje Recruiting
Ishøj, Denmark, 2635
Contact: Ida Nøhr, Dentist         
Principal Investigator: Mette K Keller, Dentist, PhD         
Sponsors and Collaborators
University of Copenhagen
  More Information

No publications provided

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
Study First Received: November 28, 2012
Last Updated: November 29, 2012
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by University of Copenhagen:
Probiotic bacteria
Caries dentalis
QLF

ClinicalTrials.gov processed this record on April 17, 2014