Hu Deyu, Zhang Yun Po, Chaknis Patricia, Petrone Margaret E, Volpe Anthony R, DeVizio William
College of Stomatology, West China University of Medical Sciences, Chengdu, China.
J Clin Dent. 2004;15(1):6-10.
This double-blind clinical study was designed to investigate the relative effectiveness of a new desensitizing test dentifrice containing 5.5% potassium citrate, 1.14% sodium monofluorophosphate (MFP) and 10% high-cleaning silica (HCS) in a silica base for reducing dentinal hypersensitivity over an eight-week period, to that of a commercially available desensitizing positive control dentifrice containing 3.75% potassium chloride, 0.32% sodium fluoride and 0.3% triclosan in a silica base.
A total of 80 subjects were entered into the study, and stratified into two balanced groups according to their baseline mean thermal (air blast) and baseline mean tactile (Yeaple Probe) sensitivity scores. The two groups were randomly assigned to use either the test dentifrice containing potassium citrate/MFP/HCS, or the positive control dentifrice containing potassium chloride/sodium fluoride/triclosan. The two groups were well balanced with regard to their mean baseline thermal and tactile sensitivity scores, sex and age. Subjects were instructed to brush their teeth twice daily (morning and evening) for one minute with their assigned dentifrice and a commercially available soft-bristled toothbrush. Dentinal hypersensitivity examinations, which included tactile sensitivity and thermal sensitivity, were conducted at baseline, four weeks, and eight weeks. Examinations were conducted by the same dental examiner on the subjects at each examination.
After four weeks' use of their assigned products, those subjects in the test dentifrice group demonstrated no statistically significant difference for controlling dentinal hypersensitivity as compared to the positive control dentifrice group in tactile and air blast. After eight weeks' use of their assigned products, those subjects in the test dentifrice group again demonstrated no statistically significant difference in tactile and air blast sensitivity as compared to the positive control dentifrice group.
The results of this double-blind clinical study indicate that the use of a commercially available test dentifrice containing 5.5% potassium citrate, 1.14% sodium monofluorophosphate and 10% high-cleaning silica in a silica base demonstrates no statistically significant difference in tactile and air blast sensitivity compared to the commercially available desensitizing positive control dentifrice containing 3.75% potassium chloride, 0.32% sodium fluoride and 0.3% triclosan in a silica base.
本双盲临床研究旨在调查一种新型脱敏试验牙膏(含5.5%柠檬酸钾、1.14%单氟磷酸钠(MFP)和10%高清洁度二氧化硅(HCS)的二氧化硅基牙膏)在八周时间内降低牙本质过敏的相对有效性,与一种市售脱敏阳性对照牙膏(含3.75%氯化钾、0.32%氟化钠和0.3%三氯生的二氧化硅基牙膏)相比。
共有80名受试者进入该研究,并根据其基线平均热(气喷)和基线平均触觉(耶普尔探针)敏感性评分分为两个均衡组。两组被随机分配使用含柠檬酸钾/MFP/HCS的试验牙膏或含氯化钾/氟化钠/三氯生的阳性对照牙膏。两组在平均基线热和触觉敏感性评分、性别和年龄方面均衡良好。受试者被指示每天用指定的牙膏和市售软毛牙刷早晚各刷牙一分钟。在基线、四周和八周时进行牙本质过敏检查,包括触觉敏感性和热敏感性检查。每次检查均由同一位牙科检查者对受试者进行检查。
在使用指定产品四周后,试验牙膏组的受试者在控制牙本质过敏方面,与阳性对照牙膏组相比,在触觉和气喷方面无统计学显著差异。在使用指定产品八周后,试验牙膏组的受试者在触觉和气喷敏感性方面再次与阳性对照牙膏组相比无统计学显著差异。
本双盲临床研究结果表明,与含3.75%氯化钾、0.32%氟化钠和0.3%三氯生的市售脱敏阳性对照二氧化硅基牙膏相比,使用含5.5%柠檬酸钾、1.14%单氟磷酸钠和10%高清洁度二氧化硅的市售试验牙膏在触觉和气喷敏感性方面无统计学显著差异。