8％精氨酸牙膏降低牙本质敏感的临床试验

摘要

目的 评价含8％精氨酸的抗敏牙膏控制牙本质敏感的效果.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处用气枪吹压缩空气,由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.按照纳入和排除标准纳入受试者,基线时共纳入受试者88人,按照性别和年龄将受试者分层随机分为试验组和对照组,每组44人.试验组使用含8％精氨酸的抗敏牙膏,对照组使用含5.53％柠檬酸钾的抗敏感牙膏.基线调查后,用棉签将1 cm长的牙膏涂抹于敏感牙表面并按摩1 min,进行敏感检测.受试者使用分派的牙膏和牙刷每天刷牙2次,每次至少1 min,分别在第3天和1周时接受回访.结果 所有受试者均完成了1周的临床试验研究.试验组和对照组受试者基线时的冷空气喷吹敏感VAS值(分别为55.51 ±8.48、56.67±10.22)和自我评价敏感VAS值(分别为43.75±6.65、41.98±8.53)差异均无统计学意义(P＞0.05).局部涂抹牙膏并按摩1 min,刷牙3d和1周后试验组冷空气喷吹敏感VAS值和自我评价敏感VAS值均较基线时显著下降(P＜0.01),对照组虽有下降但差异均无统计学意义(P＞0.05).与基线相比,试验组冷空气喷吹敏感VAS值和自我评价敏感VAS值的减少程度在3个时间点均显著高于对照组(P＜0.05).结论 含8％精氨酸的抗敏牙膏在单次局部涂抹后能即刻缓解牙本质敏感,刷牙1周后可有效缓解牙本质敏感.%Objective To evaluate the desensitizing effect of a new toothpaste containing 8％ arginine,calcium carbonate,and 1450 mg/kg fluoride as sodium monofluorophosphate(MFP).Methods This was a 1-week randomized,double-blinded,controlled,parallel-design clinical trial.A total of 88 subjects were recruited into the study and stratified into 2 balanced groups according to their baseline air blast sensitivity scores in visual analogue scale(VAS).The two groups were randomly assigned to use either the new arginine toothpaste or the commercially available desensitizing toothpaste containing 5.53％ potassium citrate.After baseline examination,a single topical application of the assigned toothpaste was directly onto the hypersensitive surface of each of the two baseline-designated hypersensitive teeth and massaged each surface for one minute.Then,the subjects were asked to brush their teeth twice-daily athome with the assigned toothpaste and a commercially available soft-bristled toothbrush for one week.Dentin hypersensitivity assessments,in air blast and self-perceived,were conducted at baseline,immediately after direct topical application,and after three days and one week of toothpaste use.Results A total of 88 subjects (44 in test and 44 in control groups) completed the study.At baseline,there was no statistically significant differences in mean air blast sensitivity VAS score ( 55.51 ± 8.48 in test group and 56.67 ±10.22 in control group ) and self-perceived sensitivity VAS score between the two groups(43.75 ± 6.65 in test group and 41.98 ± 8.53 in control group) (P ＞ 0.05 ).Compared to the control group,the test group exhibited statistically significant reductions (P ＜ 0.05 ) in air blast sensitivity VAS score ( 12.61 ± 12.86) and self-perceived sensitivity VAS score( 12.95 ± 8.29) immediately after directly application.Relative to the control toothpaste groups,the 8％ arginine group exhibited statistically significant( P ＜ 0.05 ) reductions in sensitivity after the subsequent three days ( 15.16 ± 13.21 in air blast sensitivity VAS score and 13.33 ±8.38 in self-perceived sensitivity VAS score) and one week( 15.80 ± 16.48 in air blast sensitivity VAS score and 14.49 ± 11.04 in self-perceived sensitivity VAS score ) of twice-daily regular tooth brushing.Conclusions A single topical application of a new 8％ arginine toothpaste directly onto the hypersensitive surface of teeth provides significant immediate improvement in dentin hypersensitivity.The improvement demonstrated by the 8％ arginine toothpaste after directly application was maintained after three days and one week of twice-daily brushing.