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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

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Caries Dietary Supplement: Probiotic Lactobacilli reuteri Dietary Supplement: Placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Study Start Date : December 2010
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011
Arms and Interventions
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Arm Intervention/treatment
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


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

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

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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 Posted: October 4, 2012    Key Record Dates
Last Update Posted: October 4, 2012
Last Verified: October 2012

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