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新型含硝酸根和磷酸盐稳定的氟化亚锡牙膏(SNaP)的抗菌效果:体外研究和随机对照试验。

Antibacterial Effects of a Novel Stannous Fluoride Toothpaste Stabilized With Nitrate and Phosphates (SNaP): In Vitro Study and Randomized Controlled Trial.

机构信息

Senior Research Scientist Research and Development, Colgate-Palmolive Co., Piscataway, New Jersey.

Associate Professor, Department of Oral Biology, Faculty of Dentistry, Mahidol University, Bangkok, Thailand.

出版信息

Compend Contin Educ Dent. 2024 Nov-Dec;45(Suppl 3):12-19.

PMID:39566483
Abstract

BACKGROUND

Stannous fluoride has long been an effective antibacterial, anticaries, antisensitivity, and antigingivitis addition to toothpaste formulas. However, in the past its chemical properties in aqueous solution have made it difficult to stabilize with desirable results. The recent development of a novel formulation of 0.454% stannous fluoride stabilized with nitrate and phosphates (SNaP) has resulted in prolonged therapeutic effect without compromising product experience and esthetics.

METHODS

Dentifrice antibacterial performance in vitro was determined through bacterial bioenergetics measured via rate of oxygen consumption and extracellular acidification in real-time comparing the SNaP toothpaste, a stannous fluoride positive control toothpaste, a non-antibacterial negative control toothpaste, and no treatment. Also, a single- center, randomized, controlled, double-blinded, clinical investigation of 98 subjects was performed to analyze dentifrice antibacterial performance in vivo following twice daily treatment with SNaP toothpaste (n = 48) and non-antibacterial control toothpaste (n = 50). Oral microenvironments, including plaque, tongue, cheek, gum, and saliva, of study participants 12 hours post-brushing were analyzed for bacterial load at baseline, 2 weeks, and 4 weeks.

RESULTS

In vitro treatment of biofilms with SNaP toothpaste resulted in significant suppression of bacterial respiration and glycolysis compared to a positive control, negative control, and no treatment. In the clinical trial, treatment with SNaP toothpaste showed significantly lower bacterial load in all oral microenvironments 12 hours post-brushing after 2 weeks (all: P less than .01) and 4 weeks (all: P less than .05) compared to non-antibacterial negative control toothpaste. Compared to baseline, SNaP toothpaste significantly reduced bacteria from tongue (P = .007) and saliva (P less than .001) at week 2, and from all microenvironments by week 4 (all: P ≤ .001).

CONCLUSIONS

SNaP toothpaste provided significantly greater and more sustained antibacterial effects than other tested toothpastes. Stannous fluoride, when stabilized in the SNaP formulation, effectively inhibited bacterial respiration and glycolysis in saliva-derived in vitro biofilms. The specific stabilization strategy used in SNaP toothpaste is critical for the antibacterial performance of stannous fluoride, as this formulation was more effective at reducing bacterial metabolic activity than a toothpaste containing the same amount of stannous fluoride stabilized with gluconate. The clinical study supports the in vitro findings by showing that the regular use of SNaP toothpaste leads to a significant and prolonged reduction in viable bacterial counts of five oral microenvironments.

PRACTICAL IMPLICATIONS

The highly stabilized stannous ion in SNaP toothpaste confers potent, sustained antibacterial activity that can contribute to improved oral hygiene and potentially reduce the risk of tooth decay, early gum disease, calculus, and halitosis, which have been linked to oral bacteria.

摘要

背景

氟化亚锡长期以来一直是一种有效的抗菌、抗龋、抗敏感和抗牙龈炎添加剂,用于牙膏配方中。然而,过去其在水溶液中的化学性质使其难以稳定,效果不尽如人意。最近开发了一种新型的 0.454%氟化亚锡稳定配方,其中含有硝酸盐和磷酸盐(SNaP),这一配方延长了治疗效果,同时又不影响产品的体验和美观。

方法

通过实时测量耗氧量和细胞外酸化率来比较 SNaP 牙膏、含氟化亚锡的阳性对照牙膏、不含抗菌剂的阴性对照牙膏和无处理组的细菌生物能量,体外评估 SNaP 牙膏的抗菌性能。此外,还进行了一项单中心、随机、对照、双盲、临床研究,98 名受试者每天两次使用 SNaP 牙膏(n=48)和不含抗菌剂的对照牙膏(n=50)进行治疗,分析 SNaP 牙膏治疗后 12 小时内的牙膏的抗菌性能。在基线、2 周和 4 周时,分析研究参与者刷牙后 12 小时的口腔微环境,包括菌斑、舌、颊、牙龈和唾液,分析细菌负荷。

结果

与阳性对照、阴性对照和无处理组相比,SNaP 牙膏处理生物膜后,细菌呼吸和糖酵解显著受到抑制。临床试验中,与不含抗菌剂的阴性对照牙膏相比,SNaP 牙膏在治疗后 2 周和 4 周时,所有口腔微环境中的细菌负荷均显著降低(均 P<.01)。与基线相比,SNaP 牙膏在第 2 周时显著降低了舌(P=0.007)和唾液(P<.001)中的细菌数量,在第 4 周时显著降低了所有口腔微环境中的细菌数量(均 P<.001)。

结论

SNaP 牙膏提供了比其他测试牙膏更显著和更持久的抗菌效果。在唾液来源的体外生物膜中,稳定的氟化亚锡有效地抑制了细菌的呼吸和糖酵解。SNaP 牙膏中使用的特定稳定策略对于氟化亚锡的抗菌性能至关重要,因为与使用葡萄糖酸盐稳定的含相同量氟化亚锡的牙膏相比,这种配方更能有效降低细菌的代谢活性。临床研究支持了体外研究结果,表明定期使用 SNaP 牙膏可显著且持续降低五种口腔微环境中的活菌数。

实际意义

SNaP 牙膏中高度稳定的亚锡离子具有强大、持久的抗菌活性,有助于改善口腔卫生,并可能降低龋齿、早期牙龈疾病、牙石和口臭的风险,这些都与口腔细菌有关。

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