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含硝酸盐和焦磷酸盐稳定的氟化亚锡牙膏(SNaP)治疗牙本质过敏症的效果:体外研究和随机对照试验。

Effect of a Stannous Fluoride Toothpaste Stabilized With Nitrate and Phosphates (SNaP) on Dentin Hypersensitivity: In Vitro Study and Randomized Controlled Trial.

机构信息

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

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

出版信息

Compend Contin Educ Dent. 2024 Nov-Dec;45(Suppl 3):30-39.

Abstract

BACKGROUND

Dentin hypersensitivity is a global oral health concern. This in vitro study and clinical evaluation tested the efficacy of 0.454% stannous fluoride toothpaste stabilized with nitrate and phosphates (SNaP) to occlude dentin and reduce dentin hypersensitivity.

METHODS

Human dentin specimens were treated with test and control toothpaste slurries and evaluated for dentin occlusion. In a phase III randomized controlled trial, eligible participants were randomized to SNaP toothpaste (test group), a potassium nitrate desensitizing dentifrice (positive control), or a non-desensitizing sodium monofluorophosphate dentifrice (negative control). Baseline, day 1, day 3, and day 7 dentin hypersensitivity was assessed using tactile and air blast stimuli. Mean tactile and air blast hypersensitivity scores were calculated for each treatment group. For statistical analysis, significance was set to P ≤ .05.

RESULTS

In vitro mean percent tubule occlusion for test and control samples were 86% and 35%, respectively (P less than .05). One-hundred-twenty participants completed the clinical trial. After 7 days of product use, relative to the positive control and negative control groups, the test group exhibited significant reduction in tactile hypersensitivity (79.8% and 90.2%, respectively; P less than .001) and reduction in air blast hypersensitivity (47.1% and 47.9%, respectively; P less than .001). SNaP significantly reduced hypersensitivity pain after 1, 3, and 7 days.

CONCLUSIONS

In vitro and clinical evaluation results indicate that SNaP is highly effective in coating the dentin surface, occluding exposed dentin tubules, and offering sensitivity relief from the first day of use, a benefit that continues to improve with use.

PRACTICAL IMPLICATIONS

This multi-benefit formula reduces dentin hypersensitivity, thereby improving the daily lives of patients, promoting better oral health, and potentially helping patients avoid more serious dental problems in the future.

摘要

背景

牙本质敏感是全球口腔健康关注的问题。本体外研究和临床评估测试了含有硝酸根和磷酸盐稳定的 0.454%氟化亚锡牙膏(SNaP)的功效,以封闭牙本质并减轻牙本质敏感。

方法

用人牙本质标本用测试和对照牙膏糊剂处理,并评估牙本质封闭效果。在 III 期随机对照试验中,合格的参与者被随机分配到 SNaP 牙膏(试验组)、硝酸钾脱敏牙膏(阳性对照组)或非脱敏单氟磷酸钠牙膏(阴性对照组)。使用触觉和空气喷射刺激在基线、第 1 天、第 3 天和第 7 天评估牙本质敏感。计算每个治疗组的平均触觉和空气喷射敏感评分。统计学分析的显著性水平设为 P ≤.05。

结果

体外试验中,测试和对照样本的平均管腔闭塞百分比分别为 86%和 35%(P <.05)。120 名参与者完成了临床试验。与阳性对照组和阴性对照组相比,在使用产品 7 天后,试验组的触觉敏感性显著降低(分别为 79.8%和 90.2%;P <.001),空气喷射敏感性降低(分别为 47.1%和 47.9%;P <.001)。SNaP 在使用第 1、3 和 7 天时显著减轻了敏感性疼痛。

结论

体外和临床评估结果表明,SNaP 高度有效地覆盖牙本质表面,封闭暴露的牙本质小管,并在使用的第一天就提供敏感性缓解,这种益处随着使用的增加而不断改善。

实用意义

这种多效配方可减轻牙本质敏感,从而改善患者的日常生活,促进更好的口腔健康,并有可能帮助患者避免未来更严重的牙齿问题。

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