Acid Production in Dental Plaque After Exposure to Probiotic Bacteria

• ClinicalTrials.gov Identifier: NCT01700712
• Recruitment Status: Completed
• First Posted: October 4, 2012
• Last Update Posted: October 4, 2012
• Sponsor: University of Copenhagen
• Collaborators: BioGaia AB; Calcin foundation, Denmark
• Information provided by (Responsible Party): Mette Kirstine Keller, University of Copenhagen

Tracking Information

• First Submitted Date: October 2, 2012
• First Posted Date: October 4, 2012
• Last Update Posted Date: October 4, 2012
• Study Start Date: December 2010
• Actual Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: October 3, 2012): Acid production in plaque after exposure to probiotic bacteria [ Time Frame: 2 weeks ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures (submitted: October 3, 2012): Acid producton in plaque after in vitro exposure to probiotic bacteria [ Time Frame: 1 hour ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Acid Production in Dental Plaque After Exposure to Probiotic Bacteria
• Official Title: Not Provided

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention
• Condition: Caries

Intervention

• Dietary Supplement: Probiotic Lactobacilli reuteri
• Dietary Supplement: Placebo

Study Arms

• Active Comparator: L. reuteri (DSM 17938 and ATCC PTA 5289; 1x108 CFU
  2 tablets a day for 2 weeks
  Intervention: Dietary Supplement: Probiotic Lactobacilli reuteri
• Placebo Comparator: Sugar pill
  2 tablets a day for 2 weeks
  Intervention: Dietary Supplement: Placebo

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 3, 2012): 18
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: October 2011
• Actual Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Denmark

Administrative Information

• NCT Number: NCT01700712
• Other Study ID Numbers: H-2-2010-112
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Mette Kirstine Keller, University of Copenhagen
• Study Sponsor: University of Copenhagen

Collaborators

• BioGaia AB
• Calcin foundation, Denmark

Investigators

• Principal Investigator: Mette K Keller, PhD; University of Copenhagen

• PRS Account: University of Copenhagen
• Verification Date: October 2012