Preventive Effect of a Probiotic Tablet on Oral Health in Preschool Children
1 other identifier
interventional
138
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2012
CompletedFirst Posted
Study publicly available on registry
November 2, 2012
CompletedStudy Start
First participant enrolled
February 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedMay 29, 2015
May 1, 2015
1.8 years
October 31, 2012
May 28, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Caries increment in primary teeth
Caries is recorded by clinical examinations with mirror and explorer
after 1 year of intervention
Study Arms (2)
Probiotic tablet
ACTIVE COMPARATORa tablet with three probiotic streptococci strains (S. uberis KJ2, S. oralis KJ3 and S. rattus JH145) at a concentration of 3x108 CFU
Sugar pill
PLACEBO COMPARATORThe same tablet but without active probiotic bacteria
Interventions
Intake of one probiotic lozenge tablet per day
Eligibility Criteria
You may qualify if:
- uncompromised general health,
- no cavities or severe dental diseases,
- and not mentally or physically disabled
You may not qualify if:
- Children that are uncooperative or totally reject dental examination are excluded
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Public Dental Clinic, Folktandvården Rosengård, Wachtmeistersväg 13
Malmo, Skåne County, 213 73, Sweden
Related Publications (1)
Hedayati-Hajikand T, Lundberg U, Eldh C, Twetman S. Effect of probiotic chewing tablets on early childhood caries--a randomized controlled trial. BMC Oral Health. 2015 Sep 24;15(1):112. doi: 10.1186/s12903-015-0096-5.
PMID: 26403472DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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
- Professor
Study Record Dates
First Submitted
October 31, 2012
First Posted
November 2, 2012
Study Start
February 1, 2013
Primary Completion
December 1, 2014
Study Completion
May 1, 2015
Last Updated
May 29, 2015
Record last verified: 2015-05