Department of Preventive Dentistry, Guanghua School of Stomatology, Sun Yat-sen University, Guangzhou, China.
Clin Ther. 2012 Mar;34(3):614-22. doi: 10.1016/j.clinthera.2012.01.027. Epub 2012 Mar 3.
Studies of dentifrices containing strontium chloride or potassium nitrate have documented the clinical efficacy of these formulations for dentin hypersensitivity (DH), but few studies have evaluated dentifrices containing both active ingredients.
The objective of this study was to compare the effects on DH of a dentifrice containing 2% strontium chloride and 5% potassium nitrate in a silica base (experimental dentifrice) with those of a dentifrice containing the same silica base without any active ingredient (control dentifrice).
Male and female patients aged 20 to 65 years with DH were eligible to participate in this randomized, double-blind, placebo-controlled study in China. Patients were assigned to receive the experimental or control dentifrice. At baseline, immediately after topical dentifrice use, and after 3 days, patients received an oral examination of their hard and soft tissues, followed by an evaluation of DH that used the Yeaple Probe to measure tactile hypersensitivity and the Schiff Cold Air Scale to measure the perception of pain from an air blast stimulus. Adverse events (in particular, discomfort while brushing or alteration in taste) in the oral hard or soft tissues were monitored throughout the study.
A total of 81 patients were enrolled (40 in the experimental group; 41 in the control group), of whom 79 (55 women; 24 men) completed the study. After topical use, the experimental group had a significantly higher mean (SD) tactile hypersensitivity score (19.47 [14.69] vs 14.27 [5.76]; P = 0.047) and a significantly lower mean air blast hypersensitivity score (1.93 [0.51] vs 2.22 [0.60]; P = 0.026) than did the control group. After 3 days, the experimental group had a significantly higher mean tactile hypersensitivity score (19.87 [14.95] vs 14.51 [6.00]; P = 0.045) and a significantly lower air blast hypersensitivity score (1.80 [0.56] and 2.13 [0.60]; P = 0.014) than the control group. After topical use and after 3 days, the experimental group had increases from baseline in tactile scores of 54.04% and 56.67%, respectively (both, P = 0.001) and reductions from baseline in air blast scores of 18.51% and 24.21% (both, P < 0.001); the control group had increases in tactile scores of 21.14% and 21.54% (P = 0.022 and P = 0.007) and reductions in air blast scores of 10.24% and 13.41% (P = 0.001 and P < 0.001). No adverse events were reported throughout the study.
In these patients with DH in China, the dentifrice containing 2% strontium chloride and 5% potassium nitrate was efficacious in reducing DH when used instantly after topical dentifrice use and after 3 days of use.
研究表明,含有氯化锶或硝酸钾的牙膏制剂在治疗牙本质敏感(DH)方面具有临床疗效,但很少有研究评估同时含有这两种活性成分的牙膏。
本研究旨在比较含有 2%氯化锶和 5%硝酸钾的牙膏(实验组)与含有相同二氧化硅基底但不含任何活性成分的牙膏(对照组)对 DH 的影响。
在中国,年龄在 20 至 65 岁之间、患有 DH 的男性和女性患者有资格参加这项随机、双盲、安慰剂对照研究。患者被分配接受实验组或对照组的牙膏。在基线时、局部使用牙膏后即刻以及使用后 3 天,患者接受了口腔软硬组织的口腔检查,然后使用 Yeaple 探针测量触觉敏感性,使用 Schiff 冷空气量表测量空气刺激引起的疼痛感知,对 DH 进行评估。在整个研究过程中监测口腔硬组织或软组织的不良事件(特别是刷牙时的不适或味觉改变)。
共有 81 名患者入组(实验组 40 名,对照组 41 名),其中 79 名(55 名女性,24 名男性)完成了研究。局部使用后,实验组的触觉敏感性评分(19.47 [14.69] 比 14.27 [5.76];P = 0.047)明显更高,空气 blast 敏感性评分(1.93 [0.51] 比 2.22 [0.60];P = 0.026)明显更低,明显低于对照组。使用 3 天后,实验组的触觉敏感性评分(19.87 [14.95] 比 14.51 [6.00];P = 0.045)明显更高,空气 blast 敏感性评分(1.80 [0.56] 和 2.13 [0.60];P = 0.014)明显更低,明显低于对照组。局部使用后和使用 3 天后,实验组的触觉评分分别增加了 54.04%和 56.67%(均为 P = 0.001),空气 blast 评分分别降低了 18.51%和 24.21%(均为 P < 0.001);对照组的触觉评分分别增加了 21.14%和 21.54%(P = 0.022 和 P = 0.007),空气 blast 评分分别降低了 10.24%和 13.41%(P = 0.001 和 P < 0.001)。整个研究过程中均未报告不良事件。
在中国患有 DH 的这些患者中,含有 2%氯化锶和 5%硝酸钾的牙膏在局部使用后即刻和使用 3 天后即刻使用时,对减轻 DH 具有疗效。