In situ anticaries efficacy of dentifrices with different formulations - A pooled analysis of results from three randomized clinical trials.

ABSTRACT

OBJECTIVES: Data generated from three similar in situ caries crossover studies presented the opportunity to conduct a pooled analysis to investigate how dentifrice formulations with different fluoride salts and combinations at concentrations of 1400-1450 ppm F, different abrasive systems and in some cases, carbomer (Carb), affect enamel caries lesion remineralization and fluoridation. METHODS: Subjects continuously wore modified partial dentures holding two gauze-covered partially-demineralized human enamel specimens for 14 days and brushed 2×/day with their assigned dentifrice Study 1 sodium fluoride (NaF)/Carb/silica, NaF/silica, NaF + monofluorophosphate (MFP)/chalk; Study 2 NaF/Carb/silica, NaF + MFP/dical, amine fluoride (AmF)/silica; Study 3 NaF/Carb/silica, NaF + stannous fluoride (SnF2)/silica/hexametaphosphate (HMP). All studies included Placebo (0 ppm F) and/or dose-response controls (675 ppm F as NaF [675F-NaF]) ±Carb. Specimens were evaluated for percentage surface microhardness recovery (SMHR) and enamel fluoride uptake (EFU). RESULTS: All 1400-1450 ppm F dentifrices except NaF + SnF2/silica/HMP provided significantly greater lesion remineralization than Placebo (p < 0.0001) differences in SMHR ranged from 17.46% (NaF + MFP/dical) to 26.66% (AmF/silica). For EFU (back-transformed log EFU), all 1400-1450 ppm F dentifrices gave significant fluoride uptake compared to Placebo (p < 0.0001) increases in EFU ranged from 4.95 µg F/cm2 (NaF + SnF2/silica/HMP) to 16.32 µg F/cm2 (NaF/carb/silica). Dentifrices containing NaF or AmF as sole fluoride source provided the greatest remineralization and fluoridation; Carb addition did not alter fluoride efficacy; some excipients appeared to interfere with the cariostatic action of fluoride. Treatments were generally well-tolerated with ≤4 treatment-related adverse events per study. CONCLUSION: Commercially available fluoride dentifrices varied greatly in their ability to remineralize and fluoridate early caries lesions. CLINICAL SIGNIFICANCE: Fluoride dentifrices are the most impactful anticaries modality worldwide. While clinical caries trials have not consistently shown the superiority of one formulation over another, these findings using a sensitive in situ caries model indicated that dentifrices containing NaF or AmF as the sole fluoride source provided the greatest remineralization and fluoridation benefits.