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Acid Production in Dental Plaque After Exposure to Probiotic Bacteria

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01700712
First Posted: October 4, 2012
Last Update Posted: October 4, 2012
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.
Collaborators:
BioGaia AB
Calcin foundation, Denmark
Information provided by (Responsible Party):
Mette Kirstine Keller, University of Copenhagen
  Purpose

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.


Condition Intervention
Caries Dietary Supplement: Probiotic Lactobacilli reuteri Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Further study details as provided by Mette Kirstine Keller, University of Copenhagen:

Primary Outcome Measures:
  • Acid production in plaque after exposure to probiotic bacteria [ Time Frame: 2 weeks ]

Secondary Outcome Measures:
  • Acid producton in plaque after in vitro exposure to probiotic bacteria [ Time Frame: 1 hour ]

Enrollment: 18
Study Start Date: December 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: L. reuteri (DSM 17938 and ATCC PTA 5289; 1x108 CFU
2 tablets a day for 2 weeks
Dietary Supplement: Probiotic Lactobacilli reuteri
Placebo Comparator: Sugar pill
2 tablets a day for 2 weeks
Dietary Supplement: Placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01700712


Locations
Denmark
University of Copenhagen
Copenhagen, Denmark, 2100
Sponsors and Collaborators
University of Copenhagen
BioGaia AB
Calcin foundation, Denmark
Investigators
Principal Investigator: Mette K Keller, PhD University of Copenhagen
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mette Kirstine Keller, Reasearch Associate, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01700712     History of Changes
Other Study ID Numbers: H-2-2010-112
First Submitted: October 2, 2012
First Posted: October 4, 2012
Last Update Posted: October 4, 2012
Last Verified: October 2012

Keywords provided by Mette Kirstine Keller, University of Copenhagen:
Caries, probiotic bacteria