Clinical evaluation of the ability of CaviStat in a mint confection to inhibit the development of dental caries in children.

OBJECTIVE: The aim of the present study was to determine if a sugarless mint containing CaviStat (an arginine bicarbonate calcium carbonate complex) is capable of preventing the development of dental caries in the primary molars and first permanent molars of 10 1/2- to 11-year-old Venezuelan children.
METHODS: Two-hundred children were entered into this one-year study who showed the following: (i) age between 10 1/2 and 11 years; (ii) first and second primary molars still present; (iii) sound primary molars or early caries lesions in any of these teeth; and (iv) at least some caries in the primary or permanent teeth as evidence of caries activity. Out of the 200 children initially selected, 195 finished and provided complete data. Children entered into the study were examined and then randomly divided into two groups (A and B), with distribution performed on the basis of the DMFS levels of the first permanent molars. All subjects were examined visually by a single examiner using good artificial light, mirror, and probe. Group A received a sugarless confection containing CaviStat (BasicMints); Group B received a sugarless mint control that contained all ingredients except for the CaviStat. Packaging and appearance of both types of mints were identical, except for their A and B designations.
RESULTS: Mean differences in DMFS, defs, and DMFS + defs scores between Groups A and B were determined. In the first permanent molars and some early erupting premolars and second molars, the data showed 75.6% fewer caries in Group A than in Group B children after six months, and 50.7% fewer after 12 months. Corresponding defs scores showed reduced development of dental caries in deciduous molars of 76.7% after six months and 131.3% after 12 months. Combined DMFS and defs scores showed 76.2 and 74.8% fewer caries lesions at six and 12 months, respectively. As exfoliation of primary molars occurred during the study period (approximately equal in the two groups), a proportion correction was made to allow for caries score reductions due to lesions lost because of such exfoliation. When this was done, the results at the end of the study still showed larger caries reductions in Group A than in the Group B subjects, and statistical analyses showed these differences were still highly significant (p < 0.001). Noncavitated caries lesions in the first permanent molars were also determined. These showed once again less caries development in Group A than in Group B subjects, and did so at both six and twelve months (57.0 and 52.4%, respectively). Levels of statistical significance at these times were p = 0.013 and 0.005.
CONCLUSION: It was evident from this clinical trial that mint confections containing CaviStat are able to inhibit both caries onset and caries progression. As a result, one can conclude that CaviStat mint confection technology is a simple and economical means for reducing substantially one of the most prevalent diseases in these children.

RCT Entities:   Population Interventions Outcomes