Casein phosphopeptide (CPP) has the potential to be added to mouth rinses, gels, toothpastes, chewing gums and confectioneries. Until now CPP has been studied in vitro, in situ and in animals, but clinical trials are lacking. This study was conducted to evaluate the efficacy of CPP-containing toothpaste in preventing dental caries in schoolchildren. The study was conducted among 150 schoolchildren randomly divided into three groups, each using one of three types of toothpastes: (a) containing 2% w/w CPP; (b) containing 1,190 mg/kg fluoride as 0.76% sodium monofluorophosphate (SMFP); (c) placebo toothpaste without CPP or fluoride. Students brushed with the given toothpastes for 24 months. Oral hygiene and caries experience were assessed at baseline, 12 and 24 months. The increments in caries lesions were calculated and analyzed to assess the caries-preventive effect. A significant reduction in caries increment was observed among students using CPP toothpaste or SMFP toothpaste, compared with the group using the placebo toothpaste. The reduction in caries increment was not significantly different between the CPP and SMFP groups. Oral Hygiene Index score increased from the 12-month to the 24-month examination. It is concluded that CPP can be effectively incorporated into calcium carbonate-based toothpaste and that toothpaste containing CPP is effective in preventing caries. Toothpaste containing 2% CPP seemed to have an efficacy similar to paste containing 1,190 mg/kg SMFP in the prevention of caries.

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