抗敏感牙膏缓解牙本质敏感的临床试验研究

A clinical study on the effectiveness of desensitizing toothpaste in patients with dentine hypersensitivity

目的:评价有效成分为5.53%(质量分数)柠檬酸钾的抗敏感牙膏缓解牙本质敏感的效果。方法:采用随机、对照、双盲的研究方法。牙本质敏感的评价采用冷空气喷吹法,在常温下,距离牙面1 cm处气枪吹压缩空气,受试者确认是否敏感,采用数字化疼痛评判法(visual analogue scale,VAS)记录受试者的敏感程度。按照临床试验研究受试者纳入和排除标准纳入受试者。基线时纳入受试者67人,按照性别和年龄组将纳入的受试者分层随机分为试验组和对照组,试验组36人,对照组31人。试验组使用含5.53%(质量分数)柠檬酸钾的抗敏感牙膏,对照组使用空白对照牙膏,每天刷牙两次,每次至少1 min,在基线、4周、8周时分别回访受试者。结果:65名受试者完成了8周的临床试验研究,57名受试者(试验组31人,对照组26人)符合研究过程的各项要求,其资料用于结果评价。从基线到8周评价期间,试验组和对照组受试者的冷刺激敏感VAS值和主观敏感VAS值均显著减少,试验组和对照组受试者从基线到4周冷刺激敏感VAS值的变化差异有统计学意义(P<0.05),从基线到8周时主观敏感VAS值的变化在两组间差异也有统计学意义(P<0.05)。结论:临床试验结果表明含有5.53%柠檬酸钾的抗敏感牙膏可有效缓解牙本质敏感。

Objective：To evaluate the effectiveness of desensitizing toothpaste containing 5.53% potassium citrate on dentine hypersensitivity.Methods： This was a randomized,double-blinded,controlled,clinical trial.Those,who satisfied the inclusion criteria,were recruited into the study and randomized allocated into test group and control group according to gender and age group.At baseline,67 subjects（36 in test group,31 in control group） were recruited into the study.The dentine hypersensitivity was evalu-ated by a subject self-perceived short,sharp pain in visual analogue scale（VAS） in response to a blast of cold air from a triple syringe administered to a tooth surface in 1 cm.Test toothpastes,containing 5.53% potassium citrate and 0.76% sodium monofluorophosphate,and control toothpastes,containing only 0.76% sodium monofluorophosphate were delivered to the study subjects in the test and control group respectively.The subjects were asked to brush their teeth twice a day,and at least one minute each time.During the 8-week study period,a subjective evaluation of changes in the individuals overall sensitivity to everyday stimuli was also scored in VAS.Results： At the end of the trial data of 57 subjects（31 in test group,26 in control group） was used for analysis.From baseline to 8-week evaluation,the mean VAS values to cold air and subjects＇ self-perceived VAS values of the subjects decreased both in the test and control groups.Furthermore,the reduction in mean VAS values to cold air from baseline to 4-week of the test subjects was statistically significant higher than that of the control（1.12 vs.0.32,P0.05）.The reduction in mean subjects＇ self-perceived VAS values from baseline to 8-week of the test subjects was statistically significant higher than that of the control（1.59 vs.0.24,P0.05）.Conclusion： Results of the clinical trial showed that toothpastes containing 5.53% potassium citrate were effective in reducing dentine hypersensitivity.