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一项随机临床试验,旨在衡量新型稳定化氟化亚锡牙膏与对照牙膏相比的防龋益处。

A Randomized Clinical Trial to Measure the Erosion Protection Benefits of a Novel Stabilized Stannous Fluoride Dentifrice versus a Control Dentifrice.

作者信息

Zhao Xinyi, He Tao, He Yanyan, Cheng Cathy, Chen Haijing

机构信息

School of Stomatology, the Fourth Military Medical University, Xi'an, China.

Procter & Gamble, Mason, OH, USA.

出版信息

J Clin Dent. 2017 Dec;28(4 Spec No B):B17-20.

Abstract

OBJECTIVES

The aim of this investigation was to assess the erosion protection ability of a novel stabilized stannous fluoride (SnF2) dentifrice and a control sodium fluoride dentifrice (NaF) using a well-credentialed human in situ model.

METHODS

A novel smooth texture 0.454% stabilized SnF2 dentifrice (Crest® Pro-Health™ smooth formula) and a 0.23% NaF marketed control dentifrice with 5% potassium nitrate (Sensodyne® Pronamel®) were compared in a 10-day, single center, randomized, controlled, double-blind, two-treatment, three-period crossover in situ clinical trial. Subjects wore a mandibular buccal appliance fitted with eight enamel specimens for approximately six hours over the course of each study day. Twice daily, subjects brushed the lingual surfaces of their teeth for 30 seconds while wearing the appliance, then swished with their assigned treatment toothpaste slurry for 90 seconds under the supervision of clinic staff. Erosive acid challenges with a citric acid-containing beverage (commercial orange juice) were done four times each day.

RESULTS

The SnF2 dentifrice provided 26.9% greater erosion protection relative to the NaF dentifrice at Day 10 (p < 0.03). Adjusted means of enamel surface loss at Day 10 were 9.117 µm for the SnF2 dentifrice and 12.471 µm for the NaF marketed control.

CONCLUSIONS

These results demonstrate the stabilized SnF2 dentifrice offered greater protection over the NaF dentifrice against the initiation and progression of dental erosion.

摘要

目的

本研究旨在使用一个具有充分可信度的人体原位模型,评估一种新型稳定化氟化亚锡(SnF₂)牙膏和对照氟化钠牙膏(NaF)的防酸蚀能力。

方法

在一项为期10天的单中心、随机、对照、双盲、双处理、三阶段交叉原位临床试验中,对一种新型质地光滑的0.454%稳定化SnF₂牙膏(佳洁士®专业健康™光滑配方)和一种市售的含5%硝酸钾的0.23% NaF对照牙膏(舒适达®专业修复®)进行了比较。在每个研究日期间,受试者佩戴一个下颌颊侧装置,该装置装有8个牙釉质标本,佩戴约6小时。受试者每天两次在佩戴装置时刷牙30秒,然后在临床工作人员的监督下用指定的牙膏浆液漱口90秒。每天用含柠檬酸的饮料(市售橙汁)进行4次酸蚀挑战。

结果

在第10天,SnF₂牙膏相对于NaF牙膏提供了高26.9%的防酸蚀保护(p < 0.03)。第10天牙釉质表面损失的校正均值,SnF₂牙膏为9.117 µm,市售NaF对照牙膏为12.471 µm。

结论

这些结果表明,稳定化SnF₂牙膏相对于NaF牙膏,在预防和抑制牙酸蚀的起始和进展方面提供了更好的保护。

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