含NovaMin生物活性材料的牙膏抗牙本质过敏的临床试验

目的评价含NovaMin生物活性材料的牙膏对牙本质过敏的临床效果.方法遵照随机、双盲、对照的原则.按纳入和排除标准将75名受试者随机分成3组实验组含NovaMin生物活性材料的牙膏;阴性对照组不含NovaMin生物活性材料的牙膏和阳性对照组临床已证明抗过敏有效的牙膏.采用VAS记分评价空气刺激以及冷水刺激4颗过敏牙的的敏感程度.结果使用牙膏6周后,试验组和阳性组可显著减少牙本质过敏症状.试验组经空气刺激和冷水刺激的VAS 记分降低率分别为22%和39%,阳性试验组经空气刺激和冷饮水刺激的VAS 记分分别降低了19%和22%.阴性组使用六周后,VAS记分无显著性差异(P>0.05).结论含NovaMin生物活性材料的牙膏和阳性组牙膏有抗牙本质过敏的临床效果.

A Clinical Evaluation of a Dentifrice Containing Bioactive Glass (NovaMin) on Dentine Hypersensitivity

Objective: The efficacy of a dentifrice containing Bioactive Glass (NovaMin) (test) in relieving dentine hypersensitivity has been evaluated clinically by means of a comparison to a clinically proved anti-sensitivity toothpaste containing SrCl 2 (positive control) and a dentifrice without NovaMin (placebo, negative control) over a 6 week period time. Methods: Seventy-five subjects with age ranging from 20 to 56 years old finished the study. Results: The results showed that the mean values of the VAS scores resulting from the air stimulus and cold water were reduced significantly (P<0.01) in both test and positive control group after six weeks of tooth brushing. After 6 weeks use, the reduction in the test group was 22% for air and 39% for cold water and in the positive control group it was 19% for air and 22% for cold water. There was no significant difference of the mean values of the VAS scores in the negative control group without NovaMin between baseline and 6 weeks. No product related adverse events on oral soft tissue were found in this six week study. Conclusions: The results of this study showed that the test dentifrice containing NovaMin and the positive control toothpaste reduced dentine sensitivity significantly over the 6-week study.