Caries inhibition of a dentifrice containing 0.78% sodium monofluorophosphate in a silica base

The purpose of this double blind clinical trial was to determine the anticaries activity of a dentifrice containing 0.78% sodium monofluorophosphate in a silica gel abrasive base compared with a placebo under conditions of supervised brushing. 1154 schoolchildren, ages 9-12, were recruited in a non-fluoridated semi-rural area of northeastern Connecticut. Subjects were stratified according to school, grade and sex, and then randomly divided into two groups. Each school day, children brushed their teeth for 1 min under supervision by project personnel. Weekend and vacation usage was ad libitum. Caries examinations and radiographic readings were performed by the same examiner (J.R.). After 12 months, the 996 subjects examined showed that the group using the test dentifrice had significantly (less than 0.05) lower DMFT (25.0%) and DMFS (19.1%) increments than the group using the placebo. After 24 months the 876 subjects examined showed that the test group continued to have significantly lower DMFT (24.5%) and DMFS (24.7%) increments than the placebo group. Surface protection after 24 months ranged from 22.1% for occlusal to 37.1% for interproximal surfaces.