title: Effect of probiotic chewing tablets on early childhood caries--a randomized controlled trial.
abstract: BACKGROUND
  To evaluate the effect of probiotic chewing tablets on early childhood caries development in preschool children living in a low socioeconomic multicultural area.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier: NCT01720771 . First received: October 31, 2012.
authors.affiliation: Public Dental Care Service, Scania Region, Sweden. trifa.hedayati-hajikand@regionorebrolan.se.|Postgraduate Dental Education Center, Region Örebro län, Sweden. trifa.hedayati-hajikand@regionorebrolan.se.
authors.forename: Trifa
authors.initials: T
authors.lastname: Hedayati-Hajikand
authors.affiliation: Public Dental Care Service, Scania Region, Sweden. ulrika.lundberg@skane.se.
authors.forename: Ulrika
authors.initials: U
authors.lastname: Lundberg
authors.affiliation: Public Dental Care Service, Scania Region, Sweden. catarina.eldh@skane.se.
authors.forename: Catarina
authors.initials: C
authors.lastname: Eldh
authors.affiliation: Department of Odontology, Faculty of Health and Medical Sciences, University of Copenhagen, Nørre Allé 20, 2200, Copenhagen, Denmark. stwe@sund.ku.dk.
authors.forename: Svante
authors.initials: S
authors.lastname: Twetman
mesh_terms: D002327:Cariostatic Agents / Q000627:therapeutic use; D002675:Child, Preschool; D018864:Cultural Diversity; D004245:DMF Index; D003731:Dental Caries / Q000517:prevention & control*; D003773:Dental Plaque / Q000517:prevention & control; D004311:Double-Blind Method; D005260:Female; D005459:Fluorides / Q000627:therapeutic use; D005500:Follow-Up Studies; D006801:Humans; D057194:Intention to Treat Analysis; D008297:Male; D010512:Periodontal Index; D010919:Placebos; D011203:Poverty; D019936:Probiotics / Q000627:therapeutic use*; D040242:Risk Reduction Behavior; D013607:Tablets; D014099:Toothbrushing / Q000379:methods; D014100:Toothpastes / Q000627:therapeutic use
chemical_list: D002327:Cariostatic Agents; D010919:Placebos; D013607:Tablets; D014100:Toothpastes; D005459:Fluorides