Caries prevention using a 1.2% sodium monofluorophosphate dentifrice in an aluminium oxide trihydrate base

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Abstract
A 3-yr clinical trial was carried out in France just after fluoride toothpaste was allowed to be sold on the mass market. The caries preventive effect of a toothpaste containing the maximum fluoride level permitted by the EEC (1.2% SMFP [sodium monofluorophosphate]) was assessed. The trial started with 1318 10-12-yr-old children from a wide socioeconomic background in a typical French community. Test toothpaste was given to 659 children whereas the remaining 659 children obtained the same toothpaste without the fluoride additive. The brushing was unsupervised and performed by the children at home. Dental caries was assessed by clinical and radiographic examinations. A total of 1061 children completed the trial. An interview carried out at the final examination identified a group of 116 uncooperative children (< 5 brushings a week on average) who were not included in the statistical analysis. The following mean reductions were found: 26% for DMFT [decayed, missing or filled teeth], 27% for DMFS [decayed, missing or filled surfaces], and 39% for DMFSU [decayed, missing or filled unerupted surfaces]. The DMFS index for approximal, buccal-lingual and occlusal surfaces showed caries reductions of 32, 25 and 22%, respectively. The trial demonstrated a highly significant effectiveness of the 1.2% SMFP toothpaste in a French population.