Acid Production in Dental Plaque After Exposure to Probiotic Bacteria
1 other identifier
interventional
18
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2010
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 2, 2012
CompletedFirst Posted
Study publicly available on registry
October 4, 2012
CompletedOctober 4, 2012
October 1, 2012
10 months
October 2, 2012
October 3, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Acid production in plaque after exposure to probiotic bacteria
2 weeks
Secondary Outcomes (1)
Acid producton in plaque after in vitro exposure to probiotic bacteria
1 hour
Study Arms (2)
L. reuteri (DSM 17938 and ATCC PTA 5289; 1x108 CFU
ACTIVE COMPARATOR2 tablets a day for 2 weeks
Sugar pill
PLACEBO COMPARATOR2 tablets a day for 2 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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,
You may not qualify if:
- smokers,
- ingestion of probiotic bacteria within the last two months,
- ingestion of antibiotics within the last two months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Copenhagenlead
- BioGaia ABcollaborator
- Calcin foundation, Denmarkcollaborator
Study Sites (1)
University of Copenhagen
Copenhagen, 2100, Denmark
Related Publications (1)
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.
PMID: 23092239DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Mette K Keller, PhD
University of Copenhagen
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Reasearch Associate
Study Record Dates
First Submitted
October 2, 2012
First Posted
October 4, 2012
Study Start
December 1, 2010
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
October 4, 2012
Record last verified: 2012-10