Dental Caries Clinical Trial
Official title:
Bifidobacterium Lactis BB12 and Xylitol Delivered With a Novel Slow-release Pacifier
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.
Xylitol is known to reduce counts of mutans streptococci (ms) as well as mother-child
transmission of ms. Possibly xylitol delivered to infants could positively influence
colonization/metabolism of ms. By combining in a food supplement xylitol and B. lactis BB12
(a well known probiotic bacteria) we may be able to positively affect both gut and oral
colonization, reflected in both dental and general health (solid data available on the
latter aim). Though B. lactis is in wide use in baby formulas and in in vitro tests it
apparently is safe for the teeth, no clinical studies have looked at effects of its
administration to infants on oral health. Our study aims to look at caries occurrence in
infants who have received the xylitol + BB12 food supplement with a pacifier.
Recruiting of subjects to the study is completed.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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