Stephen K W, Chestnutt I G, Jacobson A P, McCall D R, Chesters R K, Huntington E, Schäfer F
Department of Adult Dental Care, University of Glasgow Dental School, UK.
Int Dent J. 1994 Jun;44(3 Suppl 1):287-95.
A three-year double blind clinical caries trial was undertaken to compare the anticaries efficacy of three types of active agent, namely sodium fluoride (NaF), sodium monofluorophosphate (SMFP) and the combination of NaF plus sodium trimetaphosphate (TMP), using two fluoride levels (1000 ppm F and 1500 ppm F). The prime objective of the study was to determine whether there was any difference in the anticaries efficacy between NaF and SMFP. The second objective was to assess the effect on caries protection of the incorporation of TMP into a NaF dentifrice formulation. The study was carried out to FDI protocol and involved 4,294 children aged 11-12 years at outset. These participants had been selected from a pool of 6,212 potential subjects on the basis of caries experience and dental eruption pattern. They were stratified by sex, examiner, presence of calculus and caries, and allocated at random to one of the six toothpastes under study. Clinical examinations were carried out at baseline and thereafter annually for 3 years. Bitewing radiographs of a subset of children were taken at baseline and at the end of the study. The outcome measure for the study, DMFS increment, was defined as the increase in caries over three years, taking into account changes occurring on individual tooth surfaces. After three years, clinical-only data for 3,517 children were available for the calculation of caries indices. The mean three-year DMFS increment for subjects using a dentifrice containing NaF alone was 6.4 per cent lower than for those using a dentifrice containing SMFP. The difference between the NaF+TMP users and the SMFP users was 8.1 percent.(ABSTRACT TRUNCATED AT 250 WORDS)
开展了一项为期三年的双盲临床龋齿试验,以比较三种活性剂(即氟化钠(NaF)、单氟磷酸钠(SMFP)以及NaF加偏磷酸钠(TMP)的组合)在两种氟含量水平(1000 ppm F和1500 ppm F)下的防龋效果。该研究的主要目的是确定NaF和SMFP在防龋效果上是否存在差异。第二个目的是评估将TMP加入NaF牙膏配方中对龋齿预防的影响。该研究按照国际牙科联合会(FDI)的方案进行,最初纳入了4294名11至12岁的儿童。这些参与者是从6212名潜在受试者中根据龋齿经历和牙齿萌出模式挑选出来的。他们按性别、检查者、牙结石和龋齿的存在情况进行分层,并随机分配到所研究的六种牙膏中的一种。在基线时以及此后的三年中每年进行临床检查。对一部分儿童在基线时和研究结束时拍摄咬合翼片。该研究的结果指标,即DMFS增量,被定义为三年内龋齿的增加量,同时考虑到各个牙齿表面发生的变化。三年后,有3517名儿童的仅临床数据可用于计算龋齿指数。使用仅含NaF牙膏的受试者的三年平均DMFS增量比使用含SMFP牙膏的受试者低6.4%。使用NaF+TMP牙膏的受试者与使用SMFP牙膏的受试者之间的差异为8.1%。(摘要截断于250字)