Clinical investigation of the anticaries efficacy of a 1.14% sodium monofluorophosphate (SMFP) calcium carbonate-based dentifrice: a two-year caries clinical trial on children in China.

OBJECTIVE: The objective of this two-year comparative investigation was to assess the anticaries efficacy of three dentifrices commercially available in China. Two products contained the stated active agent sodium monofluorophosphate (SMFP) at a concentration of 1.14%; one was calcium carbonate-based, the second was silica-based. The third dentifrice tested contained no fluoride and was calcium carbonate-based.

METHODS: Prior to the start of this double-blind, parallel-group study, all aspects of the study were reviewed and approved by the human review committee of the West China College of Stomatology, Sichuan University. All parents signed the approved consent form before the initial evaluations. A total of 1200 qualifying children living in the Chengdu, China area entered the study, and 998 children completed all aspects of the study. Subjects were randomly assigned to use one of the three dentifrices: 328 participants used the non-fluoride calcium carbonate-based dentifrice; 341 participants used the 1.14% SMFP silica-based dentifrice; and 329 participants used the 1.14% SMFP calcium carbonate-based dentifrice. Participants were instructed to brush their teeth with their assigned dentifrice twice daily. Brushing instructions were reinforced.

RESULTS: At the baseline examination, the mean dfs (decayed and filled tooth surfaces) scores of the non-fluoride dentifrice group (3.60 +/- 6.07),the 1.14% SMFP silica-based dentifrice group (3.53 +/- 5.62), and the 1.14% SMFP calcium carbonate-based dentifrice group (3.54 +/- 5.34) were not statistically different (p > 0.05). After one year, the mean dfs increment of the non-fluoride dentifrice group was 2.19 +/- 4.12, 1.69 +/- 3.12 for the 1.14% for the SMFP silica-based dentifrice group, and 1.53 +/- 3.09 for the 1.14% SMFP calcium carbonate-based dentifrice group; after two years, the mean dfs increments were 4.73 +/- 5.17, 2.98 +/- 4.42, and 2.75 +/- 4.33, respectively. Both the 1.14% SMFP calcium carbonate-based and the 1.14% SMFP silica-based dentifrices provided significantly more caries reduction than the non-fluoride silica-based dentifrice after one year (-30% and -23%) and two years (-42% and -37%) of product use. The 1.14% SMFP calcium carbonate-based dentifrice was not significantly different from the 1.14% SMFP silica-based dentifrice after one and two years of use.

CONCLUSION: The results of this clinical study indicate that the 1.14% SMFP calcium carbonate-based and the 1.14% SMFP silica-based dentifrices are effective against tooth decay compared to brushing with a non-fluoride toothpaste.