Comparative intraoral tolerance of sodium hexametaphosphate and pyrophosphate antitartar dentifrices

A randomized, controlled clinical trial was conducted to assess the relative acute oral tolerance of a novel, dual-phase, tartar control dentifrice containing 7.0% sodium hexametaphosphate (5% hexametaphosphate anion). In this 4-day study, 159 healthy adult volunteers were randomly assigned to the experimental sodium hexametaphosphate dentifrice or a marketed, single-phase, antitartar dentifrice control containing 5.0% ionic pyrophosphate. A detailed oral soft tissue examination and interview were conducted each day by blinded evaluators to elicit clinical signs and symptoms associated with ad libitum use of the assigned dentifrice. A total of 24 subjects (15% of the study population) had new symptoms/signs after baseline. By treatment, 9% of subjects in the sodium hexametaphosphate group had new findings, compared to 21% of subjects in the pyrophosphate group, and these groups differed statistically (p < 0.03, two-sided) with respect to occurrence. In addition, onset, severity, duration and clinical presentation were generally milder in the sodium hexametaphosphate group compared to the pyrophosphate control. Only one subject (in the pyrophosphate group) discontinued treatment early due to oral intolerance. In this study, the 7.0% sodium hexametaphosphate dentifrice was well-tolerated, with significantly fewer symptoms and superior overall tolerance compared to the marketed antitartar dentifrice control.