He Tao, Anastasia Mary Kay, Zsiska Marianne, Farmer Teresa, Schneiderman Eva, Milleman Jeffery L
Procter & Gamble, Mason, OH, USA.
Salus Research Inc., Fort Wayne, IN, USA.
J Clin Dent. 2017 Dec;28(4):B21-26.
To evaluate the effect of a novel stannous fluoride dentifrice with zinc citrate on calculus inhibition using both in vitro and clinical models.
Each investigation tested a novel stabilized 0.454% stannous fluoride dentifrice with zinc citrate as an anticalculus agent (Crest® Pro-Health™ smooth formula) compared to a negative control fluoride dentifrice. The in vitro study used the modified Plaque Growth and Mineralization Model (mPGM). Plaque biofilms were prepared and mineralized by alternate immersion of glass rods in human saliva and artificial mineralization solution. Treatments of 25% w/w dentifrice/water slurries were carried out for 60 seconds daily for 6 days, between saliva and mineralization solution immersions. Plaque calcium levels were determined by digestion and inductively coupled plasma optical emission spectroscopy. Student's t-test (p < 0.05) was used for statistical analysis. The clinical study was a parallel group, double-blind, randomized, and controlled trial. Following a dental prophylaxis, subjects entered a two-month run-in phase. At the end, they received a Volpe-Manhold Index (V-MI) calculus examination. Eighty (80) qualified subjects who had formed at least 9 mm of calculus on the linguals of the mandibular anterior teeth were re-prophied and randomly assigned to either the stannous fluoride dentifrice or the negative control. Subjects brushed twice daily, unsupervised, during the three-month test period, returning at Weeks 6 and 12 for safety and V-MI examinations. Statistical analyses were via ANCOVA.
In vitro mPGM: The stabilized stannous fluoride dentifrice showed 20% less in vitro tartar formation, measured as calcium accumulation normalized by biofilm mass, versus the negative control (106.95 versus 133.04 µg Ca/mg biofilm, respectively, p < 0.05). Clinical Trial: Seventy-eight (78) subjects completed with fully evaluable data. The stannous fluoride dentifrice group had 15.1% less adjusted mean calculus at Week 6 compared to the negative control group (p = 0.05) and 21.7% less calculus at Week 12 (p < 0.01). Both dentifrices were well-tolerated.
The stannous fluoride dentifrice produced significant anticalculus benefits in vitro and in a clinical trial compared to a negative control.
使用体外和临床模型评估一种新型含柠檬酸锌的氟化亚锡牙膏对牙石形成的抑制作用。
每项研究都测试了一种新型的、稳定的0.454%氟化亚锡牙膏，其中含有柠檬酸锌作为防牙石剂（佳洁士®专业健康™光滑配方），并与阴性对照氟化物牙膏进行比较。体外研究使用改良的菌斑生长和矿化模型（mPGM）。通过将玻璃棒交替浸泡在人唾液和人工矿化溶液中来制备和矿化菌斑生物膜。在唾液和矿化溶液浸泡之间，每天用25%（w/w）的牙膏/水浆液处理60秒，持续6天。通过消化和电感耦合等离子体发射光谱法测定菌斑钙水平。采用学生t检验（p<0.05）进行统计分析。临床研究是一项平行组、双盲、随机对照试验。在进行牙齿预防治疗后，受试者进入为期两个月的导入期。最后，他们接受了Volpe-Manhold指数（V-MI）牙石检查。80名在下颌前牙舌侧形成至少9毫米牙石的合格受试者再次接受预防治疗，并随机分配到氟化亚锡牙膏组或阴性对照组。在为期三个月的测试期内，受试者每天无监督地刷牙两次，在第6周和第12周返回进行安全性和V-MI检查。通过协方差分析进行统计分析。
体外mPGM：与阴性对照相比，稳定的氟化亚锡牙膏的体外牙垢形成减少了20%，以生物膜质量标准化的钙积累量衡量（分别为106.95和133.04μg Ca/mg生物膜，p<0.05）。临床试验：78名受试者完成了具有完全可评估数据的研究。与阴性对照组相比，氟化亚锡牙膏组在第6周时调整后的平均牙石量减少了15.1%（p=0.05），在第12周时牙石量减少了21.7%（p<0.01）。两种牙膏的耐受性都很好。
与阴性对照相比，氟化亚锡牙膏在体外和临床试验中都产生了显著的防牙石效果。
