Acid Production in Dental Plaque After Exposure to Probiotic Bacteria

This study has been completed.

Sponsor:

Collaborators:

BioGaia AB

Calcin foundation, Denmark

Information provided by (Responsible Party):

Mette Kirstine Keller, University of Copenhagen

ClinicalTrials.gov Identifier:

NCT01700712

First received: October 2, 2012

Last updated: October 3, 2012

Last verified: October 2012

History of Changes

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: Double Blind (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


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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):

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.


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
Study First Received:	October 2, 2012
Last Updated:	October 3, 2012

Keywords provided by Mette Kirstine Keller, University of Copenhagen:


Caries, probiotic bacteria

ClinicalTrials.gov processed this record on June 23, 2017

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