司米护齿涂剂用于固定正畸矫治过程中牙釉质脱矿治疗的临床研究

摘要

目的:验证司米护齿涂剂治疗正畸过程中牙釉质脱矿的有效性和安全性.方法:采用随机、开放、多乐氟氟化钠护齿剂阳性对照试验设计,实验组和对照组各76例.记录受试者使用前以及使用后连续3个月的釉白斑情况.检查口腔黏膜的反应、哮喘发作情况或胃部恶心情况,记录不良事件的发生.结果:完成试验病例有150例,实验组和对照组各75例,剔除比例为1.32％.3次复诊结果均表明,试验组非劣效于对照组.无不良事件记录.结论:司米护齿涂剂治疗正畸过程中牙釉质脱矿的效果非劣效于对照组多乐氟氟化钠护齿剂.%Objective:To investigate the efficacy and safety of SIMI mouthguard paint(test group) in the treatment of enamel demineralization during orthodontic therapy with fixed applince.Methods:152 cases underwent orthodontic therapy with fixed applince were included in a randomized,open,positive control trial,and were treated by SIMI and Duraphant fluoride toothpast (control group) respectively(n =76).The enamel opaque spot was observed before and 3 months after using the products.The oral mucosa reactions,asthma attacks or stomach nausea and other adverse events were recorded.Results:150 cases (n =75) completed the trial.The results showed that the test group was non-inferior compared with the control group.No adverse event was found in both groups.Conclusion:SIMI mouthguard paint is effective in control of enamel demineralization during orthodontic therapy with fixed applince.