两种单氟磷酸钠牙膏预防乳牙龋病的2年临床研究

The anticaries efficacy of two fluoride dentifrices:A two-year clinical trial in Chinese children.

目的 :比较含氟浓度为 78.95 mmol/L (15 0 0 ppm)、磨料分别为碳酸钙及二氧化硅的二种单氟磷酸钠牙膏对儿童乳牙的临床防龋效果。方法 :采用随机双盲对照法 ,对四川省成都市 12 0 0名 4岁儿童进行了为期 2年的追踪研究。受试儿童被分为 3组 ,第 l组为含氟浓度 78.95 mmol/L、磨料为二氧化硅的单氟磷酸钠牙膏(MFP/Si O2 ) ,第 2组为含氟浓度 78.95 mmol/L、磨料为碳酸钙的单氟磷酸钠牙膏 (MFP/Ca CO3) ,第 3组为对照组 ,使用不含氟的碳酸钙牙膏。分析指标为乳牙龋面均 (dfs)增长数。结果 :998名儿童完成 2年的临床观察 ,1基线检查 3组的龋面均无显著性差异 ;2 l年后的龋面均增长数 :MFP/Si O2 组为 1.6 9± 3.12 ,MFP/Ca CO3组为1.5 3± 3.0 9,与对照组 2 .19± 4.12比较分别下降 30 .1%和 2 2 .8% ;3 2年后 MFP/Si O2 组和 MFP/Ca CO3组的龋面均增长数为 2 .98± 4.42及 2 .75± 4.33,与对照组 4.73± 5 .17比较分别下降 37%和 41.9% ,差异有显著性 ,两试验组之间统计学的差异无显著性。结论 :使用含 78.95 mmol/L氟浓度 ,磨料为二氧化硅或碳酸钙的单氟磷酸钠牙膏均有明显防龋效果 ,只要严格控制含氟牙膏的用量和加强管理 ,对发病率高的幼儿乳牙 ,不失为一种值得推广的安全而有效的防龋措施。

Objective:To study the anti caries efficacy of 78.95 mmol/L MFP calcium carbonate based (MFPC) and 78.95 mmol/L MFP silica based (MFPS) dentifrice in Chinese children. Methods: A two year double blind and parallel group clinical study was performed in 998 children living in Chengdu,China.The children were randomly assigned to use one of three dentifrices:MFPC,MFPS or non fluoride dentifrice (NFD). Participants were instructed to brush their teeth with assigned toothpaste twice daily.Brushing instructions were reinforced.Results: At baseline examination, the mean dfs scores in the groups of NFD,MFPS and MFPC were 3.60±6.07,3.54±5.34 and 3.53±5.62 respectively (P> 0.05);they were 2.19±4.12,1.69±3.12 and 1.53±3.09 (P<0.01) in one year,and 4.73±5.17,2.98±4.42 and 2.75±4.33 (P<0.01) in two years respectively. Comclusion: MFPC and MFPS are effective against tooth decay as compared with NFD.