Prasad Kakarla Vv, Therathil Sona G, Agnihotri Akshata, Sreenivasan Prem K, Mateo Luis R, Cummins Diane
Department of Public Health Dentistry, SDM College of Dental Sciences and Hospital, Karnataka, India.
Colgate-Palmolive Technology Center, Piscataway, NJ, USA.
J Clin Dent. 2018 Sep;29(Spec No A):A25-32.
To compare the effects of two new fluoride toothpastes with Dual Zinc plus Arginine to the effects of a fluoride control toothpaste in reducing bacteria in oral biofilm on teeth and in multiple soft tissue locations, as well as in saliva, 12 hours after 14 and 29 days of product use.
A randomized, single-center, three-cell, double-blind, parallel-group design was employed. The study protocol was approved by an Institutional Review Board. One hundred eighty adult subjects who met inclusion and exclusion criteria and signed an informed consent form were enrolled in the study. Subjects were randomly assigned to one of the three study products: 1) 0.96% zinc (zinc oxide, zinc citrate), 1.5% L-arginine and 1450 ppm fluoride as sodium fluoride in a silica base, Test 1; 2) 0.96% zinc (zinc oxide, zinc citrate), 1.5% L-arginine and 1000 ppm fluoride as sodium fluoride in a silica base, Test 2; and 3) 1450 ppm fluoride as sodium fluoride in a silica base, Control, for twice-daily use during tooth brushing. Oral samples were collected from the teeth, tongue, oral buccal mucosa, gingiva, and saliva at baseline and 12 hours after 14 and 29 days of assigned product use and were processed, serially diluted, plated, incubated, and scored for viable bacteria. Statistical analyses were performed separately for each sample site using ANOVA and ANCOVA for within- and between-treatment comparisons, respectively.
One hundred seventy-three subjects completed the study. Relative to subjects in the Control group, subjects in the two Test groups exhibited statistically significant reductions of 29-41% in numbers of bacteria in each of the five sample areas, 12 hours after 29 days of product use. Similar results were seen after 14 days of product use, but some differences were not statistically significant, indicating that the effects of these zinc-based toothpastes build over time with continued use. The two Test toothpastes were shown to be clinically equivalent using the Fieller's confidence interval test.
Toothpastes containing 0.96% zinc (zinc oxide, zinc citrate), 1.5% L-arginine and either 1450 ppm or 1000 ppm fluoride as sodium fluoride in a silica base provide statistically significant reductions in oral bacteria on the teeth, tongue, cheeks, and gums, as well as in saliva, compared to toothpaste with fluoride alone, 12 hours after 29 days of twice-daily tooth brushing. The results demonstrate that regular and continued twice-daily use of these new toothpastes provide 12-hour whole mouth antibacterial protection for whole mouth health.
比较两种含双重锌加精氨酸的新型含氟牙膏与一种含氟对照牙膏在产品使用14天和29天后12小时，对减少牙齿、多个软组织部位以及唾液中口腔生物膜细菌的效果。
采用随机、单中心、三细胞、双盲、平行组设计。研究方案经机构审查委员会批准。180名符合纳入和排除标准并签署知情同意书的成年受试者参与了该研究。受试者被随机分配到三种研究产品之一：1）二氧化硅基质中含0.96%锌（氧化锌、柠檬酸锌）、1.5% L - 精氨酸和1450 ppm氟化钠作为氟化钠，测试1；2）二氧化硅基质中含0.96%锌（氧化锌、柠檬酸锌）、1.5% L - 精氨酸和1000 ppm氟化钠作为氟化钠，测试2；3）二氧化硅基质中含1450 ppm氟化钠作为氟化钠，对照，每天刷牙两次时使用。在基线以及分配产品使用14天和29天后12小时，从牙齿、舌头、口腔颊黏膜、牙龈和唾液中采集口腔样本，并进行处理、连续稀释、接种、培养，然后对活菌进行计数。分别对每个样本部位进行统计分析，使用方差分析（ANOVA）和协方差分析（ANCOVA）分别进行组内和组间比较。
173名受试者完成了研究。与对照组受试者相比，两个测试组的受试者在产品使用29天后12小时，五个样本区域中的每个区域细菌数量均有统计学意义的显著减少，减少了29 - 41%。在产品使用14天后也观察到了类似结果，但有些差异无统计学意义，表明这些含锌牙膏的效果会随着持续使用而逐渐增强。使用Fieller置信区间检验显示两种测试牙膏在临床上等效。
与仅含氟牙膏相比，在二氧化硅基质中含0.96%锌（氧化锌、柠檬酸锌）、1.5% L - 精氨酸以及1450 ppm或1000 ppm氟化钠作为氟化钠的牙膏，在每天刷牙两次使用29天后12小时，能使牙齿、舌头、脸颊和牙龈以及唾液中的口腔细菌数量有统计学意义的显著减少。结果表明，每天规律且持续两次使用这些新型牙膏可为全口健康提供12小时的全口抗菌保护。
