Acid Production in Dental Plaque After Exposure to Probiotic Bacteria

Caries Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01700712
• Other study ID #: H-2-2010-112
• Status: Completed
• Phase: N/A
• First received: October 2, 2012
• Last updated: October 3, 2012
• Start date: December 2010
• Est. completion date: October 2011

Study information

• Verified date: October 2012
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark:Danish Ethical Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Caries

Intervention

Dietary Supplement:
• Probiotic Lactobacilli reuteri

• Placebo

Locations

Country	Name	City	State
Denmark	University of Copenhagen	Copenhagen

Sponsors (3)

Lead Sponsor	Collaborator
University of Copenhagen	BioGaia AB, Calcin foundation, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acid production in plaque after exposure to probiotic bacteria		2 weeks	Yes
Secondary	Acid producton in plaque after in vitro exposure to probiotic bacteria		1 hour	Yes