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

This study has been completed.
Information provided by (Responsible Party):
Svante Twetman, University of Copenhagen Identifier:
First received: October 31, 2012
Last updated: May 28, 2015
Last verified: May 2015
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 Intervention
Dental Caries Dietary Supplement: probiotic tablet Dietary Supplement: sugar pill

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Svante Twetman, University of Copenhagen:

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

Enrollment: 138
Study Start Date: February 2013
Study Completion Date: May 2015
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Show Detailed Description


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01720771

Public Dental Clinic, Folktandvården Rosengård, Wachtmeistersväg 13
Malmö, Skåne, Sweden, 213 73
Sponsors and Collaborators
University of Copenhagen
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Svante Twetman, Professor, University of Copenhagen Identifier: NCT01720771     History of Changes
Other Study ID Numbers: EPN-2011/530
EPN-2011/530 ( Other Identifier: Etikprovningsnamnden )
Study First Received: October 31, 2012
Last Updated: May 28, 2015

Keywords provided by Svante Twetman, University of Copenhagen:
preschool children

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases processed this record on September 19, 2017