Acid Production in Dental Plaque After Exposure to Probio... | NCT01700712

Studies
Acid Production in Dental Plaque After Exposure to Probiotic Bacteria

NCT01700712

Sponsor

University of Copenhagen

Status

Completed

Last Update Posted

Oct 4, 2012Estimated

Enrollment

18Actual

Phase

Not Applicable

Conditions

Caries

Interventions

Probiotic Lactobacilli reuteri
Placebo

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2010

Primary Completion Date

Oct 2011Actual

Completion Date

Oct 2011Actual

First Submitted Date

Oct 2, 2012

First Submission Date that Met QC Criteria

Oct 3, 2012

First Posted Date

Oct 4, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 3, 2012

Last Update Posted Date

Oct 4, 2012Estimated

Name	Class
BioGaia AB	INDUSTRY
Calcin foundation, Denmark	OTHER

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Probiotic Lactobacilli reuteri	Dietary Supplement		L. reuteri (DSM 17938 and ATCC PTA 5289; 1x108 CFU
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Acid production in plaque after exposure to probiotic bacteria		2 weeks

Secondary Outcomes

Measure	Description	Time Frame
Acid producton in plaque after in vitro exposure to probiotic bacteria		1 hour

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mette K Keller, PhD	University of Copenhagen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Copenhagen		Copenhagen		2100	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23092239	Derived	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.