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确定美白牙膏在减少色斑方面有效性的临床研究(使用强制色斑模型)。

Clinical studies to determine the effectiveness of a whitening toothpaste at reducing stain (using a forced stain model).

作者信息

Moran J, Claydon N C A, Addy M, Newcombe R

机构信息

Department of Oral and Dental Science, University of Bristol Dental School, Bristol, UK.

出版信息

Int J Dent Hyg. 2005 Feb;3(1):25-30. doi: 10.1111/j.1601-5037.2004.00099.x.

DOI:10.1111/j.1601-5037.2004.00099.x
PMID:16451374
Abstract

AIMS

Two single centre, randomized single-blind, crossover studies were performed, to compare the effect of a test toothpaste with a conventional fluoride paste in the inhibition and removal of extrinsic dental stain promoted by repeated chlorhexidine/tea rinses.

METHODS

These studies used 24 subjects in each of two separate clinical trials. On the Friday before each trial period, the subjects received a prophylaxis to remove all staining, plaque and calculus deposits. On the following Monday, subjects were checked whether they were stain free and then under direct supervision they rinsed with a 0.2% chlorhexidine mouthrinse, immediately followed by a rinse with a warm black tea solution. This cycle was repeated hourly eight times throughout the day and on the following days until the Friday. In addition subjects also received daily a single toothpaste slurry rinse or control water rinse in the morning and lunchtime. No other form of oral hygiene was permitted during this period. On the Friday, both stain area and intensity was assessed using the Lobene Stain Index. For the stain removal study, stain was promoted again using chlorhexidine and tea rinses. After 4 days, stain was measured both prior to and immediately after brushing with the allocated toothpaste for 2 min. Subjects were then instructed to use the toothbrush at home according to their normal oral hygiene practices. On the following Wednesday, the amount of stain present was re-assessed. Each subject subsequently received a thorough prophylaxis to remove all plaque calculus and staining before starting the following periods of the study.

RESULTS

The study showed no difference in the ability of the test whitening toothpaste, control toothpaste and water control at inhibiting stain. There was also only a small difference (3.5% for product of area and intensity) between the ability of the two toothpastes to help remove stain after a single brushing. The difference was however in favour of the test product which approached a conventional level of significance (P = 0.089). There was no evidence of superiority for either of the pastes after normal home usage.

CONCLUSIONS

This study has suggested that the test product may have some advantage over the conventional paste at removing stain but the magnitude of difference would appear to be small and of little clinical relevance.

摘要

目的

开展两项单中心、随机单盲、交叉研究,比较一款试验牙膏与传统含氟牙膏在抑制和清除因反复使用洗必泰/茶水漱口而产生的外源性牙渍方面的效果。

方法

这两项研究在两项独立临床试验中各纳入24名受试者。在每个试验期前的周五,受试者接受洁治以清除所有污渍、牙菌斑和牙结石沉积物。接下来的周一,检查受试者是否无污渍,然后在直接监督下,他们先用0.2%的洗必泰漱口水漱口,紧接着用温热的红茶溶液漱口。这个循环在当天及随后几天每小时重复8次,直至周五。此外,受试者在每天上午和午餐时间还接受一次牙膏浆液漱口或对照水漱口。在此期间不允许进行其他形式的口腔卫生护理。在周五,使用洛贝内污渍指数评估污渍面积和强度。在污渍清除研究中,再次使用洗必泰漱口水和茶水漱口来促进污渍形成。4天后,在使用分配的牙膏刷牙2分钟之前和之后立即测量污渍情况。然后指导受试者在家按照其正常的口腔卫生习惯使用牙刷。在接下来的周三,重新评估存在的污渍量。在开始研究的后续阶段之前,每个受试者随后都接受了彻底的洁治以清除所有牙菌斑、牙结石和污渍。结果:研究表明,试验美白牙膏、对照牙膏和水对照在抑制污渍方面的能力没有差异。两种牙膏在单次刷牙后帮助清除污渍的能力之间也只有很小的差异(面积和强度乘积为3.5%)。然而,这种差异有利于试验产品,接近传统的显著性水平(P =

0.089)。在正常家庭使用后,没有证据表明两种牙膏中的任何一种具有优越性。

结论

这项研究表明,试验产品在去除污渍方面可能比传统牙膏有一些优势,但差异程度似乎很小,临床相关性不大。

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