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Preventive Effect of a Probiotic Tablet on Oral Health in Preschool Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01720771
Recruitment Status : Completed
First Posted : November 2, 2012
Last Update Posted : May 29, 2015
Information provided by (Responsible Party):
Svante Twetman, University of Copenhagen

Brief Summary:
The aim of the prospective project is to investigate effect of daily probiotic supplements on dental caries development in preschool children living in a low socioeconomic immigrant area in souithern Sweden. The study design is a randomised controlled trial with two parallell arms. The intervention is one probiotic tablet or placebo once daily. The null hypothesis is that the caries experience and increment will not differ betwwen the two groups.

Condition or disease Intervention/treatment Phase
Dental Caries Dietary Supplement: probiotic tablet Dietary Supplement: sugar pill Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Preventive Effect of a Probiotic Tablet on Oral Health in Preschool Children
Study Start Date : February 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Probiotic tablet
a tablet with three probiotic streptococci strains (S. uberis KJ2, S. oralis KJ3 and S. rattus JH145) at a concentration of 3x108 CFU
Dietary Supplement: probiotic tablet
Intake of one probiotic lozenge tablet per day
Other Name: Evora Kids

Placebo Comparator: Sugar pill
The same tablet but without active probiotic bacteria
Dietary Supplement: sugar pill
one tablet daily
Other Name: Evora kids (placebo)

Primary Outcome Measures :
  1. Caries increment in primary teeth [ Time Frame: after 1 year of intervention ]
    Caries is recorded by clinical examinations with mirror and explorer

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:)

  • uncompromised general health,
  • no cavities or severe dental diseases,
  • and not mentally or physically disabled

Exclusion Criteria:

  • Children that are uncooperative or totally reject dental examination are excluded

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01720771

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Public Dental Clinic, Folktandvården Rosengård, Wachtmeistersväg 13
Malmö, Skåne, Sweden, 213 73
Sponsors and Collaborators
University of Copenhagen
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Svante Twetman, Professor, University of Copenhagen Identifier: NCT01720771    
Other Study ID Numbers: EPN-2011/530
EPN-2011/530 ( Other Identifier: Etikprovningsnamnden )
First Posted: November 2, 2012    Key Record Dates
Last Update Posted: May 29, 2015
Last Verified: May 2015
Keywords provided by Svante Twetman, University of Copenhagen:
preschool children
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases