Dental Caries Clinical Trial
Official title:
Bifidobacterium Lactis BB12 and Xylitol Delivered With a Novel Slow-release Pacifier
Verified date | January 2013 |
Source | University of Turku |
Contact | n/a |
Is FDA regulated | No |
Health authority | Finland: Ethics Committee |
Study type | Interventional |
Aims:
1. To develop a food supplement containing a health-promoting probiotic bacteria (B.
lactis BB12) and xylitol to be administered with a novel soft, possibly
occlusion-friendly pacifier.
2. Test in a clinical study how feasible the method is and to study how the intervention
affects caries occurrence.
Main hypothesis:
The administration of B. lactis BB12 and xylitol affects beneficially the dental health of
the child.
Status | Completed |
Enrollment | 106 |
Est. completion date | August 2012 |
Est. primary completion date | August 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 1 Month to 4 Years |
Eligibility |
Inclusion Criteria: - The infant is healthy - The family agrees to use the novel slow-release pacifier - The infant starts to use the pacifier before the age of 3 months Exclusion Criteria: - The child is not healthy |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Finland | Health Care Centre | Muurame and Korpilahti |
Lead Sponsor | Collaborator |
---|---|
University of Turku | Chr Hansen A/S, Fennobon oy, Karkkila, Finland (provides the tablets for the pacifier), Plastone Oy, Konnevesi, Finland (provides the pacifiers) |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | MS colonization | 2 years | No | |
Secondary | Acute infectious diseases | 2 years | No | |
Secondary | Caries occurrence | 4 years | No |
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