Gasparri Franco, Schemehorn Bruce Richard, Zanardi Andrea
Department of Pharmacy (DIFARMA), University of Salerno, Salerno, Italy.
Thermetric Technologies, Inc., Noblesville, IN, USA.
J Clin Dent. 2018 Mar;29(1):13-17.
Two different studies were conducted to evaluate the whitening efficacy of a mouthwash versus a placebo using in vitro and in vivomodels. The tested mouthwash was formulated with no oxidizing or abrasive agents containing chlorhexidine (CHX) and polyvinylpyrrolidone (PVP).
The purpose of the in vitro study was to determine whether the mouthwash formulation OC15AB could reduce the accumulation of staining in an accepted stain model. Bovine central incisors were cut to obtain enamel specimens of ~8 × 8 mm2. The specimens were then immersed in human saliva (room temperature, slight stirring) for one hour to allow a pellicle film to form. They were then placed in contact with a staining solution containing coffee and tea. The amount of stain (tooth color) was quantified photometrically (Minolta C221 colorimeter) using the L* value of the Lab* scale. The purpose of the in vivo study was to evaluate the whitening power and tolerability of OC15AB versus a placebo mouthwash in a double-blind, randomized clinical study. In total, 40 subjects were divided randomly into two homogeneous groups. Each group used a different mouthwash (OC15AB or placebo) for 56 consecutive days. During this period, clinical and instrumental parameters, namely variations in tooth color and mucosal and gum alterations, were evaluated. The in vivo study analyses used a two-sided Student's t-test. Evaluations within groups used t-tests for paired data.
From the in vitro test, OC15AB had a significant effect in reducing stain accumulation over the entire treatment period. The in vivo test showed that OC15AB was well tolerated and had whitening power in the subjects. OC15AB demonstrated a statistically significant reduction in extrinsic tooth staining from baseline and versus the placebo.
The in vitro and in vivo methods used to investigate the whitening efficacy of the mouthwash formulation produced similar and consistent results. The experimental model used is an important tool in the search for new technologies for teeth whitening. Our preliminary experimental data confirm the possibility of achieving a whitening effect using a mouthwash formulation with no oxidizing or abrasive agents containing CHX and PVP. The formulation tested demonstrated a significant reduction, in vitro and in vivo, in extrinsic tooth staining from baseline and versus the placebo.
进行了两项不同的研究,使用体外和体内模型评估一种漱口水与安慰剂相比的美白效果。所测试的漱口水配方中不含氧化或研磨剂,含有氯己定(CHX)和聚乙烯吡咯烷酮(PVP)。
体外研究的目的是确定漱口水配方OC15AB是否能在公认的染色模型中减少染色积累。将牛中切牙切割以获得约8×8mm²的牙釉质标本。然后将标本浸入人唾液中(室温,轻微搅拌)一小时,以使薄膜形成。然后将它们与含有咖啡和茶的染色溶液接触。使用Lab色空间的L值通过光度法(美能达C221色度计)对染色量(牙齿颜色)进行量化。体内研究的目的是在一项双盲、随机临床研究中评估OC15AB与安慰剂漱口水相比的美白能力和耐受性。总共40名受试者被随机分为两个同质组。每组连续56天使用不同的漱口水(OC15AB或安慰剂)。在此期间进行临床和仪器参数评估,即牙齿颜色变化以及黏膜和牙龈改变。体内研究分析使用双侧学生t检验。组内评估使用配对数据的t检验。
体外测试表明,OC15AB在整个治疗期间对减少染色积累有显著效果。体内测试表明,OC15AB在受试者中耐受性良好且具有美白能力。与基线相比以及与安慰剂相比,OC15AB在外源性牙齿染色方面显示出统计学上的显著降低。
用于研究漱口水配方美白效果的体外和体内方法产生了相似且一致的结果。所使用的实验模型是寻找牙齿美白新技术的重要工具。我们的初步实验数据证实了使用不含氧化或研磨剂、含有CHX和PVP的漱口水配方实现美白效果的可能性。所测试的配方在体外和体内均显示出与基线相比以及与安慰剂相比外源性牙齿染色显著降低。