The online version of this article (doi:10.1186/s12903-015-0096-5) contains supplementary material, which is available to authorized users.
The authors have no conflict of interest to declare. The authors alone are responsible for the content and writing of the paper.
The project was planned and implemented by THH and ST. UL and CE carried out the clinical registrations and supervised the management team. The calibration of the examiners was led by THH. The statistical analyses and interpretation of data was made by THH and ST who also prepared the first draft. The manuscript was prepared according to the CONSORT guidelines. All authors contributed to the final draft and approved the final manuscript.
To evaluate the effect of probiotic chewing tablets on early childhood caries development in preschool children living in a low socioeconomic multicultural area.
The investigation employed a randomized double-blind placebo-controlled design. The study group consisted of 138 healthy 2-3-year-old children that were consecutively recruited after informed parental consent. After enrollment, they were randomized to a test or a placebo group. The parents of the test group were instructed to give their child one chewing tablet per day containing three strains of live probiotic bacteria (ProBiora3®) and the placebo group got identical tablets without bacteria. The duration was one year and the prevalence and increment of initial and manifest caries lesions was examined at baseline and follow-up. All parents were thoroughly instructed to brush the teeth of their off-springs twice daily with fluoride toothpaste.
The groups were balanced at baseline and the attrition rate was 20 %. Around 2/3 of the children in both groups reported an acceptable compliance. The caries increment (Δds) was significantly lower in the test group when compared with the placebo group, 0.2 vs. 0.8 (p < 0.05). The risk reduction was 0.47 (95 % CI 0.24–0.98) and the number needed to treat close to five. No differences were displayed between the groups concerning presence of visible plaque or bleeding-on-brushing. No side effects were reported.
The results suggested that early childhood caries development could be reduced through administration of these probiotic chewing tablets as adjunct to daily use of fluoride toothpaste in preschool children. Further studies on a possible dose–response relationship seem justified
ClinicalTrials.gov Identifier: NCT01720771. First received: October 31, 2012.
Additional file 1: CONSORT 2010 checklist of information to include when reporting a randomised trial. (DOC 217 kb)12903_2015_96_MOESM1_ESM.doc
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- Effect of probiotic chewing tablets on early childhood caries – a randomized controlled trial
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