Abstract
Aim: To assess changes of the International Caries Detection and Assessment System (ICDAS) codes in primary dentition in a 3-year double-blind randomised controlled prospective clinical trial with three different polyols erythritol, xylitol, and sorbitol (control).
Methods: A representative sample (n=522) of the 1st and 2nd year primary school children in Southeast Estonia were included. The Research Ethics Committee of the University of Tartu approved the study (166/T-7). Clinical trial registration: NCT01062633. Written informed consent was obtained from the parents/caregivers. The participants (n=485, 93%) were randomly (according to classrooms) allocated into three groups: erythritol (n=165), xylitol (156), and control (164). Polyol-containing candies with a daily polyol consumption of 3 x 2.5g were administered on school days by the teachers. Clinical examinations were completed four times (baseline in 2008, 12-, 24-, 36 months of intervention). There were four examiners and their inter-examiner and intra- examiner repeatability was high, the weighted kappa >0.9. In the analyses, the ICDAS codes 1-3 were combined to enamel caries teeth, d1-3mft and surfaces, d1-3mfs and the ICDAS codes 4-6 to d4-6mft and d4-6mfs. Comparisons between the groups were performed with the nonparametric methods due to skewed distributions. The differences in caries indices between the groups were compared with Kruskal-Wallis test.
Results: Caries indices (d4-6t/d4-6s) were statistically significantly lowest in the erythritol group after 24 months (0.59/0.89; p=0.04/0.04) and after 36 months (0.47/0.53, p=0.08/0.04) of the intervention, compared to the control (0.93/1.3) after 24 months and (0.72/1.06) after 36 months and to the xylitol (0.96/1.63) after 24 months and (0.67/1.03) after 36 months groups.
Conclusion: Erythritol seemed to have the strongest caries preventive effect with the lowest mean caries indices after 24- and 36 months intervention in the primary dentition.
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