Sharma Deepak, McGuire James A, Gallob John T, Amini Pejmon
Oral Care Research and Development, Johnson & Johnson Consumer & Personal Products Worldwide, Skillman, NJ, USA.
J Dent. 2013 Jul;41 Suppl 4:S40-8. doi: 10.1016/S0300-5712(13)70005-8.
The study aimed to determine the efficacy in relieving dentinal sensitivity of 4 weeks' treatment with an alcohol-free mouthrinse comprising 1.4% potassium oxalate (KO) (Listerine® Advanced Defence Sensitive; LADS), compared with negative and positive controls.
Subjects were randomised to one of three treatments: LADS mouthrinse - twice-daily toothbrushing with Crest® Cavity Protection Regular toothpaste, rinsing with water and then 10 mL LADS mouthrinse, followed by expectoration; negative control (twice-daily brushing with Crest Cavity Protection Regular toothpaste); or positive control (twice-daily brushing with Sensodyne® Original desensitising toothpaste). Dentine sensitivity was assessed at baseline and after 2 and 4 weeks by Yeaple probe (tactile pressure; patient-reported discomfort by visual analogue scale [VAS]), air blast (VAS) and global subjective sensitivity (VAS). Oral tolerance was monitored throughout the study.
At 2 weeks, subjects treated with the positive control and LADS mouthrinse showed significant reductions (p<0.05) in sensitivity scores versus the negative control. At 4 weeks, sensitivity decreased by 110% in the positive-control subjects versus negative-control subjects (p<0.001); sensitivity decreased by 80% in subjects receiving LADS mouthrinse versus negative-control subjects (p<0.05). No serious treatment-related oral adverse events were reported.
The positive control (Sensodyne Original) significantly reduced sensitivity compared with the negative control (Crest toothpaste alone), thus validating the study. The LADS mouthrinse (1.4% KO mouthrinse) significantly reduced sensitivity compared with the negative control, suggesting that LADS mouthrinse was responsible for the clinical effect observed. The treatments were well tolerated.
To our knowledge, this is the first randomised clinical study to demonstrate the efficacy of a KO-containing mouthrinse (LADS) in relieving dentinal sensitivity.
本研究旨在确定与阴性和阳性对照相比,使用含1.4%草酸钾(KO)的无酒精漱口水(利斯特林®高级防护敏感型漱口水;LADS)进行4周治疗对缓解牙本质敏感的疗效。
将受试者随机分为三种治疗组之一:LADS漱口水组——每天两次用佳洁士®防蛀常规牙膏刷牙,用水漱口,然后含10 mL LADS漱口水,随后吐出;阴性对照组(每天两次用佳洁士防蛀常规牙膏刷牙);或阳性对照组(每天两次用舒适达®原味脱敏牙膏刷牙)。在基线以及2周和4周后,通过耶普尔探针(触觉压力;患者通过视觉模拟量表[VAS]报告不适)、气喷(VAS)和整体主观敏感性(VAS)评估牙本质敏感性。在整个研究过程中监测口腔耐受性。
在2周时,接受阳性对照和LADS漱口水治疗的受试者与阴性对照相比,敏感性评分显著降低(p<0.05)。在4周时,阳性对照组受试者与阴性对照组受试者相比,敏感性降低了110%(p<0.001);接受LADS漱口水治疗的受试者与阴性对照组受试者相比,敏感性降低了80%(p<0.05)。未报告与治疗相关的严重口腔不良事件。
与阴性对照(仅佳洁士牙膏)相比,阳性对照(舒适达原味)显著降低了敏感性,从而验证了该研究。与阴性对照相比,LADS漱口水(1.4% KO漱口水)显著降低了敏感性,表明LADS漱口水是观察到的临床效果的原因。这些治疗耐受性良好。
据我们所知,这是第一项随机临床研究,证明含KO的漱口水(LADS)在缓解牙本质敏感方面的疗效。