Extrinsic stain prevention with a combination dentifrice containing calcium phosphate surface active builders...

A six-week, randomized and controlled, examiner blind, parallel group clinical trial was conducted to evaluate the stain prevention efficacy of an experimental whitening dentifrice containing a combination of sodium hexametaphosphate and soluble pyrophosphate relative to a marketed high-abrasive dentifrice and a marketed control dentifrice. Following the collection of baseline stain scores and subsequent prophylaxis, healthy volunteers were randomized to one of three treatment regimens, balancing for stain levels and smoking status. Throughout the six-week treatment period, subjects brushed twice daily with the assigned dentifrice while following a rinse regimen of three times daily tea and once daily chlorhexidine. At baseline, three and six weeks, dental stain was measured on the facial and lingual surfaces of the eight anterior teeth using the Lobene Index. A total of 96 subjects completed the study. At three and six weeks, adjusted stain scores were highest in the control group and generally lowest in the sodium hexametaphosphate group for all Lobene parameters (intensity, area and composite). At three weeks, stain area and composite stain scores for the sodium hexametaphosphate dentifrice were statistically significantly (p < 0.05) lower relative to the control, representing reductions of 30% and 33%, respectively. Similar numerical trends were observed after six weeks, with the sodium hexametaphosphate group showing reductions of 21% (p = 0.068) in stain area and 26% (p = 0.055) in composite stain relative to the control. The high-abrasive dentifrice was directionally, though not statistically superior to the control at three and six weeks. All three test products were well-tolerated.