A Three-year Clinical Trial of a Combination of Trimetaphosphate and Sodium Fluoride in Silica Toothpastes

Abstract

The relative efficacy of NaF silica toothpastes containing 1000 ppm fluoride and 1500 ppm fluoride in the control of dental caries is not clear-cut. Also, it has not been established that incorporation of trimetaphosphate (TMP) improves the anticaries activity of NaF toothpastes. A three-year clinical trial was conducted to test the hypotheses that: (i) the anticaries activity of NaF toothpastes containing 1500 ppm F was greater than that of NaF toothpastes containing 1000 ppm F, and (ii) inclusion of TMP improved the efficacy of NaF silica pastes. Subsidiary aims included determination of whether frequency of toothbrushing and method of rinsing after brushing were correlated with caries increments. The study involved 4196 children aged 11 to 12 years at outset. These participants had been selected from a pool of 7374 potential subjects on the basis of caries experience and dental eruption pattern. They were stratified by sex, examiner, and presence of calculus and caries, and were allocated at random to one of the four toothpastes under study. Using mirror and probe and also FOTI, we carried out clinical examinations at baseline and annually thereafter for 3 yrs. Bitewing radiographs of a subset of children were taken at baseline and at the end of the study. The outcome measure for the study, DMFS increment, was defined as the increase in caries over 3 yrs, taking into account changes occurring on individual tooth surfaces. Data for 3467 subjects were available for analyses at both baseline and year 3 examinations. Radiographs were taken for 1942 subjects at both baseline and year 3 examinations. The mean three-year clinical-only DMFS increment for the subjects using 1500-ppm-NaF pastes was 3.93, which was 6% lower than the corresponding mean of 4.19 for the 1000-ppm-NaF pastes. There was no significant difference between the mean DMFS increment for those using paste with or without TMP. Subjects who claimed to brush more frequently or who claimed not to use a tumbler to rinse after toothbrushing had lower three-year DFMS increments.

Effect of 1000 or More ppm Relative to 440 to 550 ppm Fluoride Toothpaste - A Systematic Review

“…Some clinical studies have shown that with 1000 to 2500 ppm F toothpaste an increase of 6% is obtained in dental caries protection for each 500 ppm (23,35).…”

Fluoride ingestion from toothpaste by young children

“…Clinical trials indicate that within the range 1,000 to 2,500 ppm F an increase in fluoride of around 500 ppm results in an additional 6% reduction in dental caries. 17,18 In the UK 41% of the parents of young children aged 1fi to 2fi years claim to use a toothpaste containing less than 600 ppm F. 10 Toothpastes containing higher concentrations of fluoride confer greater protection against dental caries but increase the risk of fluorosis. In contrast, low fluoride toothpastes provide less protection against dental caries but reduce the risk of fluorosis.…”

Digital transillumination in caries detection versus radiographic and clinical methods: an in-vivo study

“…The exclusion criteria were subjects wearing fixed orthodontic appliances and subjects unable to be exposed to radiographs for medical/specific reasons. Considering that caries prevalence in young adults in Italy is generally high, 14 a power analysis was performed to calculate an adequate sample size to compare the different caries detection methods. The number was fixed at 48 subjects.…”