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一项评价植酸钠牙粉配方的去渍效果的随机临床试验。

A randomized clinical trial to evaluate the stain removal efficacy of a sodium phytate dentifrice formulation.

机构信息

Salus Research, Fort Wayne, Indiana 46825.

GSK Consumer Healthcare, Weybridge, Surrey, KT13 ODE, United Kingdom.

出版信息

J Esthet Restor Dent. 2018 Mar;30(2):E45-E51. doi: 10.1111/jerd.12355. Epub 2018 Feb 7.

DOI:10.1111/jerd.12355
PMID:29411532
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5969293/
Abstract

OBJECTIVES

Phytate is an organic, cyclic polyphosphate analogous to linear condensed polyphosphates used as stain removal agents. This study investigated stain removal efficacy of an experimental sodium phytate-containing dentifrice compared to a reference dentifrice.

METHODS

An experimental, moderate abrasivity (relative dentine abrasivity [RDA] ∼130) antisensitivity fluoride dentifrice containing sodium phytate (0.85% w/w as the hexasodium salt) (n = 111) was compared to a reference, marketed, low-abrasivity (RDA ∼ 43), anti-sensitivity fluoride dentifrice (n = 113), both containing 1150 ppm fluoride as sodium fluoride. Primary efficacy variables were between-treatment differences in extrinsic dental stain of anterior teeth after 6 and 12 weeks' twice-daily use, using Lobene stain index (MacPherson modification, MLSI) mean area (A) and intensity (I) scores. Comparisons included whole-tooth and hard-to-reach areas (gingival, interproximal, body of lingual).

RESULTS

At both 6- and 12-week timepoints, MLSI (A × I) scores for total area and hard-to-reach areas for the experimental dentifrice were statistically significantly lower than baseline (P < .0001 for all). This was demonstrated for the reference dentifrice at 6 weeks only, for total, interproximal (P < .0001 for both), and body of lingual (P = .0395) scores. Compared with the reference, the experimental dentifrice had statistically significantly lower MLSI scores at both 6 and 12 weeks for all outcome variables including both total MLSI (A × I) and hard-to reach areas (P < .0001 in all cases). Products were generally well-tolerated.

CONCLUSIONS

Differences between treatments were considered clinically differentiable. Sodium phytate may therefore be a suitable additive ingredient to improve tooth stain control performance within an otherwise conventional dentifrice formulation.

CLINICAL SIGNIFICANCE

Following 6 and 12 weeks brushing, clinically differentiable differences were shown in stain index scores with an experimental dentifrice containing sodium phytate compared to a reference dentifrice without sodium phytate. Sodium phytate may therefore be a suitable additive ingredient to improve tooth stain control performance within an otherwise conventional dentifrice formulation.

摘要

目的

植酸是一种有机环状多磷酸盐,类似于用作去污剂的线性缩合多磷酸盐。本研究比较了一种含植酸钠的实验性牙膏的去污效果,这种牙膏具有中等磨蚀性(相对牙本质磨蚀率 [RDA] 约为 130),并具有抗敏感作用,同时还含有氟化物。

方法

一种实验性、中度磨蚀性(相对牙本质磨蚀率 [RDA] 约 130)、抗敏感含氟牙膏,含有植酸钠(0.85%w/w 为六钠盐)(n=111),与一种参考的市售、低磨蚀性(RDA 约为 43)、抗敏感含氟牙膏(n=113)进行比较,后者均含有 1150ppm 氟化物作为氟化钠。主要疗效变量是在使用 6 和 12 周后,使用 Lobene 染色指数(MacPherson 改良法,MLSI)的均值面积(A)和强度(I)评分,比较前门牙的外源性牙齿染色差异。比较包括整个牙齿和难以触及的区域(牙龈、邻间、舌体)。

结果

在 6 周和 12 周的时间点,实验牙膏的 MLSI(A×I)总区域和难以触及区域的评分均低于基线(所有 P<.0001)。参考牙膏仅在 6 周时显示出这一点,总评分、邻间(均 P<.0001)和舌体(P=0.0395)评分。与参考牙膏相比,在所有结局变量中,包括总 MLSI(A×I)和难以触及区域,实验牙膏在 6 周和 12 周的 MLSI 评分均具有统计学意义的显著降低(所有情况下 P<.0001)。产品普遍耐受性良好。

结论

处理之间的差异被认为具有临床可区分性。因此,植酸钠可能是一种合适的添加剂成分,可改善常规牙膏配方中牙齿染色控制性能。

临床意义

在使用含植酸钠的实验牙膏和不含植酸钠的参考牙膏刷牙 6 周和 12 周后,在染色指数评分上显示出具有临床可区分性的差异。因此,植酸钠可能是一种合适的添加剂成分,可改善常规牙膏配方中牙齿染色控制性能。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8a06/5969293/0e03885430c6/JERD-30-E45-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8a06/5969293/9b06d1f3c000/JERD-30-E45-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8a06/5969293/9c17af40ab14/JERD-30-E45-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8a06/5969293/0e03885430c6/JERD-30-E45-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8a06/5969293/9b06d1f3c000/JERD-30-E45-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8a06/5969293/9c17af40ab14/JERD-30-E45-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8a06/5969293/0e03885430c6/JERD-30-E45-g003.jpg

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