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

This study is not yet open for participant recruitment.
Verified November 2012 by University of Copenhagen
Sponsor:
Information provided by (Responsible Party):
Svante Twetman, University of Copenhagen
ClinicalTrials.gov Identifier:
NCT01720771
First received: October 31, 2012
Last updated: November 18, 2012
Last verified: November 2012
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • Caries increment in primary teeth [ Time Frame: after 1 year of intervention ] [ Designated as safety issue: No ]
    Caries is recorded by clinical examinations with mirror and explorer


Estimated Enrollment: 250
Study Start Date: February 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 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

  Eligibility

Ages Eligible for Study:   2 Years to 3 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01720771

Locations
Sweden
Public Dental Clinic, Folktandvården Rosengård, Wachtmeistersväg 13 Not yet recruiting
Malmö, Skåne, Sweden, 213 73
Contact: Trifa Hedayati, Dentist         trifa.hedayatihajikand@orebroll.se    
Sub-Investigator: Eva-Marie Mårtensson, RDH            
Sponsors and Collaborators
University of Copenhagen
  More Information

No publications provided

Responsible Party: Svante Twetman, Professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01720771     History of Changes
Other Study ID Numbers: EPN-2011/530, EPN-2011/530
Study First Received: October 31, 2012
Last Updated: November 18, 2012
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by University of Copenhagen:
bacteriotherapy
caries
preschool children
probiotics

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on June 17, 2013