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不同配方牙膏的原位抗龋效果 - 三项随机临床试验结果的汇总分析。

In situ anticaries efficacy of dentifrices with different formulations - A pooled analysis of results from three randomized clinical trials.

机构信息

Department of Cariology, Operative Dentistry and Dental Public Health, Indiana University School of Dentistry, Indianapolis, IN, USA.

GSK Consumer Healthcare, St. George's Avenue, Weybridge, Surrey, KT13 ODE, UK.

出版信息

J Dent. 2018 Oct;77:93-105. doi: 10.1016/j.jdent.2018.07.014. Epub 2018 Jul 23.

DOI:10.1016/j.jdent.2018.07.014
PMID:30048657
Abstract

OBJECTIVES

Data generated from three similar in situ caries crossover studies presented the opportunity to conduct a pooled analysis to investigate how dentifrice formulations with different fluoride salts and combinations at concentrations of 1400-1450 ppm F, different abrasive systems and in some cases, carbomer (Carb), affect enamel caries lesion remineralization and fluoridation.

METHODS

Subjects continuously wore modified partial dentures holding two gauze-covered partially-demineralized human enamel specimens for 14 days and brushed 2×/day with their assigned dentifrice: Study 1: sodium fluoride (NaF)/Carb/silica, NaF/silica, NaF + monofluorophosphate (MFP)/chalk; Study 2: NaF/Carb/silica, NaF + MFP/dical, amine fluoride (AmF)/silica; Study 3: NaF/Carb/silica, NaF + stannous fluoride (SnF)/silica/hexametaphosphate (HMP). All studies included Placebo (0 ppm F) and/or dose-response controls (675 ppm F as NaF [675F-NaF]) ±Carb. Specimens were evaluated for percentage surface microhardness recovery (SMHR) and enamel fluoride uptake (EFU).

RESULTS

All 1400-1450 ppm F dentifrices except NaF + SnF/silica/HMP provided significantly greater lesion remineralization than Placebo (p < 0.0001): differences in SMHR ranged from 17.46% (NaF + MFP/dical) to 26.66% (AmF/silica). For EFU (back-transformed log EFU), all 1400-1450 ppm F dentifrices gave significant fluoride uptake compared to Placebo (p < 0.0001): increases in EFU ranged from 4.95 μg F/cm (NaF + SnF/silica/HMP) to 16.32 μg F/cm (NaF/carb/silica). Dentifrices containing NaF or AmF as sole fluoride source provided the greatest remineralization and fluoridation; Carb addition did not alter fluoride efficacy; some excipients appeared to interfere with the cariostatic action of fluoride. Treatments were generally well-tolerated with ≤4 treatment-related adverse events per study.

CONCLUSION

Commercially available fluoride dentifrices varied greatly in their ability to remineralize and fluoridate early caries lesions.

CLINICAL SIGNIFICANCE

Fluoride dentifrices are the most impactful anticaries modality worldwide. While clinical caries trials have not consistently shown the superiority of one formulation over another, these findings using a sensitive in situ caries model indicated that dentifrices containing NaF or AmF as the sole fluoride source provided the greatest remineralization and fluoridation benefits.

摘要

目的

三项类似的原位龋齿交叉研究所产生的数据提供了机会,可以进行汇总分析,以研究不同氟化物盐和浓度为 1400-1450ppm F 的不同研磨剂系统的牙膏配方(在某些情况下还含有 Carbomer(Carb))如何影响牙釉质龋齿病变的再矿化和氟化。

方法

受试者连续佩戴改良局部义齿,每侧义齿上放置两块涂有纱布的部分脱矿的人牙釉质标本,持续佩戴 14 天,每天刷牙 2 次,使用其指定的牙膏:研究 1:氟化钠(NaF)/Carb/二氧化硅、氟化钠/二氧化硅、氟化钠+单氟磷酸钠(MFP)/白垩;研究 2:氟化钠/Carb/二氧化硅、氟化钠+MFP/二水合磷酸氢钙(dical)、胺氟化物(AmF)/二氧化硅;研究 3:氟化钠/Carb/二氧化硅、氟化钠+氟化亚锡(SnF)/二氧化硅/六偏磷酸钠(HMP)。所有研究均包括安慰剂(0ppm F)和/或剂量反应对照(675ppm F 作为 NaF [675F-NaF])±Carb。评估标本的表面显微硬度恢复百分比(SMHR)和牙釉质氟摄取量(EFU)。

结果

除了氟化钠+氟化亚锡/二氧化硅/六偏磷酸钠(NaF+SnF/silica/HMP)之外,所有浓度为 1400-1450ppm F 的牙膏都比安慰剂提供了更显著的病变再矿化效果(p<0.0001):SMHR 的差异范围为 17.46%(氟化钠+MFP/二水合磷酸氢钙)至 26.66%(胺氟化物/二氧化硅)。对于 EFU(反转换后的 log EFU),所有浓度为 1400-1450ppm F 的牙膏与安慰剂相比均显著增加了氟摄取量(p<0.0001):EFU 的增加范围为 4.95μg F/cm(氟化钠+氟化亚锡/二氧化硅/六偏磷酸钠)至 16.32μg F/cm(氟化钠/Carb/二氧化硅)。含有氟化钠或胺氟化物作为唯一氟源的牙膏提供了最大的再矿化和氟化效果;Carb 的添加并没有改变氟的功效;一些赋形剂似乎干扰了氟化物的抗龋作用。这些治疗方法通常耐受性良好,每个研究中仅有≤4 例与治疗相关的不良事件。

结论

商业上可用的含氟牙膏在再矿化和氟化早期龋齿病变方面的能力差异很大。

临床意义

氟化物牙膏是全球最具影响力的抗龋方法。虽然临床龋齿试验并未一致显示出一种制剂优于另一种制剂,但使用敏感的原位龋齿模型的这些发现表明,含有氟化钠或胺氟化物作为唯一氟源的牙膏提供了最大的再矿化和氟化益处。

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