Removal of extrinsic stain using a 7.0% sodium hexametaphosphate dentifrice: a randomized clinical trial.

A nine-week, randomized and controlled clinical trial was conducted to compare the stain removal efficacy of a 0.243% sodium fluoride dentifrice containing 7% sodium hexametaphosphate (5% hexametaphosphate anion) to that of a 0.243% sodium fluoride control dentifrice. Following prophylaxis and a three-week pre-treatment period to induce extrinsic stain, healthy adult volunteers with tooth stain were randomized to the sodium hexametaphosphate dentifrice or the control. Stain area and intensity were assessed at baseline, three and six weeks. At both three and six weeks, the sodium hexametaphosphate dentifrice was statistically significantly superior to the control for all overall stain measures (p < 0.04). After six weeks of product usage, the sodium hexametaphosphate dentifrice demonstrated reductions of 29% in composite stain, 24% in stain intensity, and 25% in stain area relative to the control. Significant reductions in composite stain were seen on both gingival and body regions for the sodium hexametaphosphate dentifrice versus the control at three and six weeks. Both products demonstrated favorable safety profiles, as determined by oral soft tissue evaluations and recording of subject-reported adverse events.