DePaola P F, Soparkar P M, Triol C, Volpe A R, Garcia L, Duffy J, Vaughan B
Department of Clinical Trials, Forsyth Dental Center, Boston, Massachusetts, United States.
Am J Dent. 1993 Sep;6 Spec No:S7-12.
A 36-month double-blind clinical caries study was conducted to determine the comparative anticaries efficacy of sodium monofluorophosphate (MFP) and sodium fluoride (NaF) as incorporated in dentifrice formulations. The test dentifrices which were utilized are commercially available in the United States and all have been granted the American Dental Association Seal of Acceptance for anticaries efficacy. The study was conducted in accordance with the 1988 Guidelines of the American Dental Association Council on Dental Therapeutics. The two formulations used in the NaF versus MFP comparison were Colgate Winterfresh Gel with 0.76% sodium monofluorophosphate in a silica base and Crest Regular Flavor Toothpaste with 0.24% sodium fluoride in a silica base. A third commercially-available NaF dentifrice, Colgate Junior Toothpaste with 0.243% sodium fluoride in a silica base, was included in the study for further comparison. Schoolchildren residing in Maine, U.S.A. received a baseline caries clinical examination and then were randomly assigned to the twice-daily use of one of the three dentifrices which were purchased in the marketplace and repackaged in plain white tubes. Caries clinical examinations were subsequently conducted after 2 and 3 years' use of the dentifrices. A total of 2,222 children participated in both the 2 and 3-year caries clinical examinations. The 36-month DFS (decayed and filled surfaces) and the DFT (decayed and filled teeth) mean caries increments for the three dentifrice groups were virtually identical. The children using the MFP formulation experienced a DFS of 1.50 and a DFT of 1.08; those using the Crest NaF formulation experienced a DFS of 1.48 and a DFT of 1.07; subjects in the third group (Colgate Junior Toothpaste, 0.243% NaF) had a DFS of 1.49 and DFT of 1.06. The statistical evaluation of the data consisted of the calculation of 90% confidence bounds for the ratio of (true) mean increments, in accordance with the 1988 American Dental Association Guidelines. Expressed in the language of the Guidelines, the analyses indicated that, (1) the anticaries efficacy provided by the MFP formulation, (Colgate Winterfresh Gel with 0.76% MFP) is "as good as" that provided by the NaF formulation, (Crest Regular Flavor Toothpaste, with 0.243% NaF), and (2) the anticaries efficacy provided by the one NaF formulation (Colgate Junior Toothpaste, with 0.243% NaF) is "as good as" that provided by the other, (Crest Regular Flavor Toothpaste, with 0.243% NaF).
开展了一项为期36个月的双盲临床龋齿研究，以确定添加在牙膏配方中的单氟磷酸钠（MFP）和氟化钠（NaF）的相对防龋效果。所使用的测试牙膏在美国均有商业销售，并且都已获得美国牙科协会的防龋功效认可标志。该研究是根据美国牙科协会牙科治疗委员会1988年的指南进行的。用于NaF与MFP比较的两种配方分别是含0.76%单氟磷酸钠的二氧化硅基高露洁冰薄荷啫喱牙膏和含0.24%氟化钠的二氧化硅基佳洁士常规口味牙膏。第三种市售的含NaF牙膏，即含0.243%氟化钠的二氧化硅基高露洁儿童牙膏，也被纳入研究以作进一步比较。居住在美国缅因州的学童接受了龋齿临床基线检查，然后被随机分配为每日两次使用从市场购买并重新包装在普通白色管中的三种牙膏之一。在使用牙膏2年和3年后分别进行了龋齿临床检查。共有2222名儿童参与了2年和3年的龋齿临床检查。三个牙膏组的36个月DFS（龋面和充填面）和DFT（龋牙和充填牙）平均龋齿增量几乎相同。使用MFP配方的儿童DFS为1.50，DFT为1.08；使用佳洁士NaF配方的儿童DFS为1.48，DFT为1.07；第三组（高露洁儿童牙膏，0.243% NaF）的受试者DFS为1.49，DFT为1.06。数据的统计评估包括根据1988年美国牙科协会指南计算（真实）平均增量比率的90%置信区间。用该指南的语言表述，分析表明，（1）MFP配方（含0.76% MFP的高露洁冰薄荷啫喱牙膏）提供防龋功效“与”NaF配方（含0.243% NaF的佳洁士常规口味牙膏）“一样好”，并且（2）一种NaF配方（含0.243% NaF的高露洁儿童牙膏）提供防龋功效“与”另一种（含0.243% NaF的佳洁士常规口味牙膏）“一样好”。
