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Acid Production in Dental Plaque After Exposure to Probiotic Bacteria

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ClinicalTrials.gov Identifier: NCT01700712
Recruitment Status : Completed
First Posted : October 4, 2012
Last Update Posted : October 4, 2012
Sponsor:
Collaborators:
BioGaia AB
Calcin foundation, Denmark
Information provided by (Responsible Party):
Mette Kirstine Keller, University of Copenhagen

Tracking Information
First Submitted Date  ICMJE October 2, 2012
First Posted Date  ICMJE October 4, 2012
Last Update Posted Date October 4, 2012
Study Start Date  ICMJE December 2010
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 3, 2012)
Acid production in plaque after exposure to probiotic bacteria [ Time Frame: 2 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 3, 2012)
Acid producton in plaque after in vitro exposure to probiotic bacteria [ Time Frame: 1 hour ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Acid Production in Dental Plaque After Exposure to Probiotic Bacteria
Official Title  ICMJE Not Provided
Brief Summary

The increasing interest in probiotic lactobacilli in health maintenance has raised the question of potential risks. One possible side effect could be an increased acidogenicity in dental plaque. The aim of this study was to investigate the effect of probiotic lactobacilli on plaque lactic acid (LA) production in vitro and in vivo.

Methods. subjects (n=18) were given lozenges with probiotic lactobacilli (L. reuteri DSM 17938 and ATCC PTA 5289) or placebo for two weeks in a double-blinded, randomized cross-over trial. The concentration of LA in supragingival plaque samples was determined at baseline and after 2 weeks. Salivary counts of mutans streptococci (MS) and lactobacilli were estimated with chair-side methods.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Caries
Intervention  ICMJE
  • Dietary Supplement: Probiotic Lactobacilli reuteri
  • Dietary Supplement: Placebo
Study Arms  ICMJE
  • Active Comparator: L. reuteri (DSM 17938 and ATCC PTA 5289; 1x108 CFU
    2 tablets a day for 2 weeks
    Intervention: Dietary Supplement: Probiotic Lactobacilli reuteri
  • Placebo Comparator: Sugar pill
    2 tablets a day for 2 weeks
    Intervention: Dietary Supplement: Placebo
Publications * Keller MK, Twetman S. Acid production in dental plaque after exposure to probiotic bacteria. BMC Oral Health. 2012 Oct 24;12:44. doi: 10.1186/1472-6831-12-44.

*   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: October 3, 2012)
18
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2011
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • moderate to high counts of salivary mutans streptococci (>104 CFU) as estimated with the Dentocult SM chair-side test,
  • no visible open caries lesions or periodontal disease,

Exclusion Criteria:

  • smokers,
  • ingestion of probiotic bacteria within the last two months,
  • ingestion of antibiotics within the last two months
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
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 NCT01700712
Other Study ID Numbers  ICMJE H-2-2010-112
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
  • BioGaia AB
  • Calcin foundation, Denmark
Investigators  ICMJE
Principal Investigator: Mette K Keller, PhD University of Copenhagen
PRS Account University of Copenhagen
Verification Date October 2012

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