Department of Preventative Dentistry, School of Medicine, College of Stomatology, National Clinical Research Center for Oral Disease, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University, Shanghai, China.
Shanghai Key Laboratory of Stomatology, Shanghai Research Institute of Stomatology, Shanghai, China.
J Clin Periodontol. 2020 Aug;47(8):962-969. doi: 10.1111/jcpe.13305. Epub 2020 Jun 8.
To compare efficacy of an anhydrous 0.454% w/w stannous fluoride/sodium fluoride toothpaste (Test) versus a sodium monofluorophosphate toothpaste (Negative control) and a stannous chloride/sodium fluoride toothpaste (Positive control) for dentine hypersensitivity relief after 8 weeks' twice-daily use.
In this randomized, examiner-blind, stratified, parallel study, primary and secondary efficacy variables were mean changes in Schiff score (evaporative [air] sensitivity) and tactile threshold (Yeaple probe), respectively, from baseline to Week 8 between Test (n = 62) and Negative control (n = 62). Test and Positive control (n = 61) comparisons were exploratory objectives.
All groups significantly improved from baseline on both dentine hypersensitivity measures (p < .0001). Difference between adjusted mean changes from baseline in Schiff sensitivity scores at Week 8 for Test versus Negative control groups was 0.19 (95% CI 0.002, 0.374), in favour of the Negative control (p = .0476; 12.57% difference). Difference in tactile threshold was -7.20 g (95% CI -16.376, 1.975), and this was not statistically significant (p = .3715; -21.83% difference). Test group showed no significant difference versus Positive control for either measure. Toothpastes were generally well tolerated.
While twice-daily use of Test toothpaste significantly reduced dentine hypersensitivity from baseline, there was no significant advantage over negative or positive controls.
Clinicaltrials.gov; NCT03310268.
比较 8 周每日两次使用无水 0.454% w/w 氟化亚锡/氟化钠牙膏（试验组）与单氟磷酸钠牙膏（阴性对照组）和氯化亚锡/氟化钠牙膏（阳性对照组）对牙本质敏感缓解的疗效。
在这项随机、 examiner 盲、分层、平行研究中，主要和次要疗效变量分别为试验组（n=62）和阴性对照组（n=62）在基线至第 8 周期间 Schiff 评分（蒸发[空气]敏感性）和 Yeaple 探针触觉阈值的平均变化，试验组（n=62）和阳性对照组（n=61）的比较是探索性的目标。
所有组在牙本质敏感测量方面均显著优于基线（p<0.0001）。试验组与阴性对照组在第 8 周时 Schiff 敏感性评分的调整均值变化差异为 0.19（95%CI 0.002，0.374），阴性对照组更优（p=0.0476；差异为 12.57%）。触觉阈值差异为-7.20g（95%CI-16.376，1.975），无统计学意义（p=0.3715；差异为-21.83%）。试验组在两种测量方法上均与阳性对照组无显著差异。牙膏总体耐受性良好。
虽然每日两次使用试验牙膏可显著降低牙本质敏感，但与阴性或阳性对照组相比，并无显著优势。
Clinicaltrials.gov；NCT03310268。
