title: The caries-preventive effect of xylitol/maltitol and erythritol/maltitol lozenges: results of a double-blinded, cluster-randomized clinical trial in an area of natural fluoridation.
abstract: OBJECTIVE
  Xylitol studies suggest caries reductions in the order of 50%. Based on animal/microbial studies, erythritol potentially has caries-preventive properties. However, clinical studies are required to confirm this. The aim of the study was to investigate the additional caries-preventive effect of xylitol/maltitol and erythritol/maltitol lozenges delivered at school, relative to controls receiving comprehensive prevention, in a low-caries prevalence population.
  
  
  METHODS
  A 4-year, cluster-randomized, double-blinded clinical trial. Five hundred and seventy-nine 10-year-old consenting subjects from 21 schools were randomly assigned to one of five groups. Four groups used the lozenges on school days, in three teacher-supervised sessions daily, over 1 or 2 years. The daily amount was 4.7 g/4.6 g for xylitol/maltitol and 4.5 g/4.2 g for erythritol/maltitol. The groups received free examinations and care in the public health centre. Four hundred and ninety-six children were analysed. The main outcome measure was dentin caries increment based on a clinical examination at 4 years since the start. The groups were compared in relation to the increment using hierarchical logistic regression to adjust for potential clustering.
  
  
  RESULTS
  Use of xylitol/maltitol or erythritol/maltitol lozenges did not result in caries reduction. A strong relationship between baseline caries prevalence and the 4-year increment was observed (OR = 7.38; 95% CI: 3.78-14.41).
  
  
  CONCLUSIONS
  The results suggest that in relatively low-caries conditions the school-based use of xylitol/maltitol or erythritol/maltitol lozenges would not have additional caries-preventive effect when compared with comprehensive prevention.
authors.affiliation: Carea Joint Municipal Authority for Medical and Social Services in Kymenlaakso, Kuusankoski, Finland. aija.hietala-lenkkeri@fimnet.fi
authors.forename: Aija-Maaria Hietala
authors.initials: AM
authors.lastname: Lenkkeri
authors.forename: Kaisu
authors.initials: K
authors.lastname: Pienihäkkinen
authors.forename: Saija
authors.initials: S
authors.lastname: Hurme
authors.forename: Pentti
authors.initials: P
authors.lastname: Alanen
mesh_terms: D002327:Cariostatic Agents / Q000008:administration & dosage / Q000032:analysis / Q000627:therapeutic use*; D002648:Child; D004245:DMF Index; D003729:Dental Care; D003731:Dental Caries / Q000517:prevention & control*; D003804:Dentin / Q000473:pathology; D004311:Double-Blind Method; D004896:Erythritol / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D005387:Finland; D005459:Fluorides / Q000032:analysis*; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008320:Maltose / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016300:Radiography, Bitewing; D018570:Risk Assessment; D013402:Sugar Alcohols / Q000008:administration & dosage / Q000627:therapeutic use*; D013549:Sweetening Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D013607:Tablets; D016896:Treatment Outcome; D014881:Water Supply / Q000032:analysis*; D014993:Xylitol / Q000008:administration & dosage / Q000627:therapeutic use*
chemical_list: D002327:Cariostatic Agents; D013402:Sugar Alcohols; D013549:Sweetening Agents; D013607:Tablets; D008320:Maltose; C010745:maltitol; D005459:Fluorides; D004896:Erythritol; D014993:Xylitol