Acid Production in Dental Plaque After Exposure to Probiotic Bacteria

NCT ID: NCT01700712

Last Updated: 2012-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-10-31

Brief Summary

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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

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Conditions

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Caries

Keywords

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Caries, probiotic bacteria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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L. reuteri (DSM 17938 and ATCC PTA 5289; 1x108 CFU

2 tablets a day for 2 weeks

Group Type ACTIVE_COMPARATOR

Probiotic Lactobacilli reuteri

Intervention Type DIETARY_SUPPLEMENT

Sugar pill

2 tablets a day for 2 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Probiotic Lactobacilli reuteri

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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BioGaia AB

INDUSTRY

Sponsor Role collaborator

Calcin foundation, Denmark

OTHER

Sponsor Role collaborator

University of Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Mette Kirstine Keller

Reasearch Associate

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mette K Keller, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Copenhagen

Locations

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University of Copenhagen

Copenhagen, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 23092239 (View on PubMed)

Other Identifiers

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H-2-2010-112

Identifier Type: -

Identifier Source: org_study_id