NCT01738958

Brief Summary

Clinical trials in children and adults have suggested that daily consumption of probiotic lactic acid bacteria can reduce caries risk and caries development in primary teeth in preschool and stop root caries in the elderly. However, it is not known whether probiotic bacteria can affect the increased porosity in young permanent teeth in children and adolescents with many cavities. It can be difficult to measure the increased porosity of the enamel by tooth decay, but this can be done using quantitative laser fluorescence (QLF). The method is based on visible light with a wavelength of 370 nm, addressing enamel. This produces an image consisting of red and green color tones and the dominant color of the enamel is green. Increased porosity of the enamel, resulting in a reduction of the auto-fluorescence and the loss (or gain) of the mineral can be quantified by means of a corresponding software. The purpose of this study is to investigate the effect of a daily supplement of probiotic lactic acid bacteria on the loss of mineral in enamel assessed with QLF. The null hypothesis is that the mineral content will not differ from baseline in either the test group or the placebo group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 30, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

December 3, 2014

Status Verified

December 1, 2014

Enrollment Period

10 months

First QC Date

November 28, 2012

Last Update Submit

December 2, 2014

Conditions

Caries Dentalis

Keywords

Probiotic bacteriaCaries dentalisQLF

Outcome Measures

Primary Outcomes (1)

  • Change in enamel porosity

    Change in enamel porosity assed by QLF

    Baseine and 12 weeks

Study Arms (2)

Probiotic lactobacilli

ACTIVE COMPARATOR

L. reuteri, two times a day for 6 weeks

Biological: L. retueri

Placebo

PLACEBO COMPARATOR

Placebo tablets, two times a day for 6 weeks

Biological: Placebo

Interventions

L. retueriBIOLOGICAL

two tablets a day for 6 weeks

Probiotic lactobacilli
PlaceboBIOLOGICAL
Placebo

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • two sites with white spot lesions in anterior teeth

You may not qualify if:

  • antibiotic treatment within 2 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ishøj kommunale tandpleje

Ishøj, 2635, Denmark

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 28, 2012

First Posted

November 30, 2012

Study Start

September 1, 2012

Primary Completion

July 1, 2013

Study Completion

March 1, 2014

Last Updated

December 3, 2014

Record last verified: 2014-12

Locations

DK(1)