Cohen S, Schiff T, McCool J, Volpe A, Petrone M E
St. Louis Jewish Hospital, St. Louis, Missouri, USA.
J Clin Dent. 1994;5 Spec No:93-6.
A randomized, two-compartment calculus clinical study of twelve-weeks duration was conducted among a group of calculus-forming subjects in the St. Louis area. The purpose of this parallel and double-blind clinical study was to compare the effect of a dentifrice containing 5.0% potassium nitrate, 1.3% soluble pyrophosphate, 1.5% PVM/MA copolymer and 0.243% sodium fluoride in a silica base, to that of a placebo dentifrice, with regard to supragingival calculus formation. The study examiner, using the Volpe-Manhold Calculus Index, selected a panel of calculus-prone men and women who had completed a one-month placebo regimen. The Volpe-Manhold Calculus Index scores and the number of completely calculus-free sites were recorded. One-hundred and fifteen subjects were entered into the study. After an oral soft and hard tissue examination, the subjects were given a complete oral prophylaxis and randomly assigned to use either the placebo or test dentifrice for a 12-week home-use period. They were prohibited from using any other means of oral hygiene during the study. After completing 12 weeks of twice-daily brushing at home using their assigned toothpaste and a standard soft-bristled toothbrush, subjects were again assessed for supragingival calculus deposits and calculus-free sites. The dentifrice containing 5.0% potassium nitrate, 1.3% soluble pyrophosphate, 1.5% PVM/MA copolymer and 0.243% sodium fluoride in a silica base, inhibited supragingival calculus formation by 54.4%, as compared to a 0.243% sodium fluoride silica-based placebo dentifrice. The mean Volpe-Manhold Calculus Index scores were compared statistically and the difference indicated statistical significance at probability of 0.01 by means of an analysis of covariance (ANCOVA). The number of calculus-free sites, a second parameter of efficacy, also was compared and demonstrated an absolute difference of 32.6% in favor of the group using the dentifrice containing potassium nitrate, soluble pyrophosphate and PVM/MA copolymer compared to a placebo dentifrice (37.8% vs 5.2%, respectively). An analysis of covariance indicated that this improvement showed statistical significance at a probability of 0.01.
在圣路易斯地区的一组结石形成受试者中进行了一项为期12周的随机双室结石临床研究。这项平行双盲临床研究的目的是比较一种含5.0%硝酸钾、1.3%可溶性焦磷酸盐、1.5%PVM/MA共聚物和0.243%氟化钠的二氧化硅基牙膏与安慰剂牙膏在龈上结石形成方面的效果。研究检查人员使用Volpe-Manhold结石指数，挑选了一组完成了为期一个月安慰剂疗程的易患结石的男性和女性。记录Volpe-Manhold结石指数得分和完全无结石部位的数量。115名受试者进入研究。在进行口腔软硬组织检查后，受试者接受了全面的口腔预防措施，并被随机分配在12周的家庭使用期内使用安慰剂或测试牙膏。在研究期间，他们被禁止使用任何其他口腔卫生方法。在在家中使用指定牙膏和标准软毛牙刷每天刷牙两次完成12周后，再次对受试者的龈上结石沉积物和无结石部位进行评估。与含0.243%氟化钠的二氧化硅基安慰剂牙膏相比，含5.0%硝酸钾、1.3%可溶性焦磷酸盐、1.5%PVM/MA共聚物和0.243%氟化钠的二氧化硅基牙膏可使龈上结石形成减少54.4%。通过协方差分析（ANCOVA）对平均Volpe-Manhold结石指数得分进行统计学比较，差异在概率为0.01时具有统计学意义。无结石部位数量作为第二个疗效参数也进行了比较，结果表明，与安慰剂牙膏相比，使用含硝酸钾、可溶性焦磷酸盐和PVM/MA共聚物牙膏的组有32.6%的绝对差异（分别为37.8%和5.2%）。协方差分析表明，这种改善在概率为0.01时具有统计学意义。
