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含三氯生/共聚物的口腔护理牙膏。

Triclosan/copolymer containing toothpastes for oral health.

作者信息

Riley Philip, Lamont Thomas

机构信息

Cochrane Oral Health Group, School of Dentistry, The University of Manchester, Coupland III Building, Oxford Road, Manchester, UK, M13 9PL.

出版信息

Cochrane Database Syst Rev. 2013 Dec 5;2013(12):CD010514. doi: 10.1002/14651858.CD010514.pub2.

Abstract

BACKGROUND

Periodontal disease and dental caries are highly prevalent oral diseases that can lead to pain and discomfort, oral hygiene and aesthetic problems, and eventually tooth loss, all of which can be costly to treat and are a burden to healthcare systems. Triclosan is an antibacterial agent with low toxicity, which, along with a copolymer for aiding retention, can be added to toothpastes to reduce plaque and gingivitis (inflammation of the gums). It is important that these additional ingredients do not interfere with the anticaries effect of the fluoride present in toothpastes, and that they are safe.

OBJECTIVES

To assess the effects of triclosan/copolymer containing fluoride toothpastes, compared with fluoride toothpastes, for the long-term control of caries, plaque and gingivitis in children and adults.

SEARCH METHODS

We searched the Cochrane Oral Health Group's Trials Register (to 19 August 2013), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2013, Issue 7), MEDLINE via OVID (1946 to 19 August 2013), EMBASE via OVID (1980 to 19 August 2013), and the US National Institutes of Health Trials Register (clinicaltrials.gov) (to 19 August 2013). We applied no restrictions regarding language or date of publication in the searches of the electronic databases.

SELECTION CRITERIA

We included randomised controlled trials (RCTs) assessing the effects triclosan/copolymer containing toothpastes on oral health.

DATA COLLECTION AND ANALYSIS

Two review authors independently assessed the search results against the inclusion criteria for this review, extracted data and carried out risk of bias assessments. We attempted to contact study authors for missing information or clarification when feasible. We combined sufficiently similar studies in meta-analyses using random-effects models when there were at least four studies (fixed-effect models when fewer than four studies), reporting mean differences (MD) for continuous data and risk ratios (RR) for dichotomous data.

MAIN RESULTS

We included 30 studies, analysing 14,835 participants, in this review. We assessed 10 studies (33%) as at low risk of bias, nine (30%) as at high risk of bias and 11 (37%) as unclear. Plaque Compared with control, after six to seven months of use, triclosan/copolymer toothpaste reduced plaque by 0.47 on a 0 to 5 scale (MD -0.47, 95% confidence interval (CI) -0.60 to -0.34, 20 studies, 2675 participants, moderate-quality evidence). The control group mean was 2.17, representing a 22% reduction in plaque. After six to seven months of use, it also reduced the proportion of sites scoring 3 to 5 on a 0 to 5 scale by 0.15 (MD -0.15, 95% CI -0.20 to -0.10, 13 studies, 1850 participants, moderate-quality evidence). The control group mean was 0.37, representing a 41% reduction in plaque severity. Gingivitis After six to nine months of use, triclosan/copolymer toothpaste reduced inflammation by 0.27 on a 0 to 3 scale (MD -0.27, 95% CI -0.33 to -0.21, 20 studies, 2743 participants, moderate-quality evidence). The control group mean was 1.22, representing a 22% reduction in inflammation. After six to seven months of use, it reduced the proportion of bleeding sites (i.e. scoring 2 or 3 on the 0 to 3 scale) by 0.13 (MD -0.13, 95% CI -0.17 to -0.08, 15 studies, 1998 participants, moderate-quality evidence). The control group mean was 0.27, representing a 48% reduction in bleeding. Periodontitis After 36 months of use, there was no evidence of a difference between triclosan/copolymer toothpaste and control in the development of periodontitis (attachment loss) (RR 0.92, 95% CI 0.67 to 1.27, one study, 480 participants, low-quality evidence). Caries After 24 to 36 months of use, triclosan/copolymer toothpaste slightly reduced coronal caries when using the decayed and filled surfaces (DFS) index (MD -0.16, 95% CI -0.31 to -0.02, four studies, 9692 participants, high-quality evidence). The control group mean was 3.44, representing a 5% reduction in coronal caries. After 36 months of use, triclosan/copolymer toothpaste probably reduced root caries (MD -0.31, 95% CI -0.39 to -0.23, one study, 1357 participants, moderate-quality evidence). Calculus After six months of use, triclosan/copolymer toothpaste may have reduced the mean total calculus per participant by 2.12 mm (MD -2.12 mm, 95% CI -3.39 to -0.84, two studies, 415 participants, low-quality evidence). The control group mean was 14.61 mm, representing a 15% reduction in calculus. Adverse effects There were no data available for meta-analysis regarding adverse effects, but 22 studies (73%) reported that there were no adverse effects caused by either the experimental or control toothpaste.There was considerable heterogeneity present in the meta-analyses for plaque, gingivitis and calculus. Plaque and gingivitis showed such consistent results that it did not affect our conclusions, but the reader may wish to interpret the results with more caution.

AUTHORS' CONCLUSIONS: There was moderate-quality evidence showing that toothpastes containing triclosan/copolymer, in addition to fluoride, reduced plaque, gingival inflammation and gingival bleeding when compared with fluoride toothpastes without triclosan/copolymer. These reductions may or may not be clinically important, and are evident regardless of initial plaque and gingivitis levels, or whether a baseline oral prophylaxis had taken place or not. High-quality evidence showed that triclosan/copolymer toothpastes lead to a small reduction in coronal caries. There was weaker evidence to show that triclosan/copolymer toothpastes may have reduced root caries and calculus, but insufficient evidence to show whether or not they prevented periodontitis. There do not appear to be any serious safety concerns regarding the use of triclosan/copolymer toothpastes in studies up to three years in duration.

摘要

背景

牙周病和龋齿是非常常见的口腔疾病,可导致疼痛和不适、口腔卫生及美观问题,最终导致牙齿脱落,所有这些治疗成本都很高,给医疗保健系统带来负担。三氯生是一种低毒抗菌剂,与一种有助于黏附的共聚物一起,可添加到牙膏中以减少牙菌斑和牙龈炎(牙龈炎症)。重要的是,这些添加成分不会干扰牙膏中氟化物的防龋效果,并且它们是安全的。

目的

评估含三氯生/共聚物的含氟牙膏与含氟牙膏相比,对儿童和成人龋齿、牙菌斑和牙龈炎的长期控制效果。

检索方法

我们检索了Cochrane口腔卫生组试验注册库(截至2013年8月19日)、Cochrane对照试验中央注册库(CENTRAL)(《Cochrane图书馆》2013年第7期)、通过OVID检索的MEDLINE(1946年至2013年8月19日)、通过OVID检索的EMBASE(1980年至2013年8月19日)以及美国国立卫生研究院试验注册库(clinicaltrials.gov)(截至2013年8月19日)。在电子数据库检索中,我们未对语言或出版日期施加限制。

选择标准

我们纳入了评估含三氯生/共聚物牙膏对口腔健康影响的随机对照试验(RCT)。

数据收集与分析

两位综述作者根据本综述的纳入标准独立评估检索结果,提取数据并进行偏倚风险评估。可行时,我们试图联系研究作者获取缺失信息或进行澄清。当至少有四项研究时,我们使用随机效应模型在荟萃分析中合并足够相似的研究(少于四项研究时使用固定效应模型),对于连续数据报告均值差(MD),对于二分数据报告风险比(RR)。

主要结果

本综述纳入了30项研究,分析了14835名参与者。我们评估10项研究(33%)偏倚风险低,9项(30%)偏倚风险高,11项(37%)不清楚。牙菌斑:与对照组相比,使用六至七个月后,三氯生/共聚物牙膏在0至5分的量表上使牙菌斑减少了0.47(MD -0.47,95%置信区间(CI)-0.60至-0.34,20项研究,2675名参与者,中等质量证据)。对照组均值为2.17,代表牙菌斑减少了22%。使用六至七个月后,它还使在0至5分的量表上得分为3至5分的部位比例降低了0.15(MD -0.15,95%CI -0.20至-0.10,13项研究,1850名参与者,中等质量证据)。对照组均值为0.37,代表牙菌斑严重程度降低了41%。牙龈炎:使用六至九个月后,三氯生/共聚物牙膏在0至3分的量表上使炎症减少了0.27(MD -0.27,95%CI -0.33至-0.21,20项研究,2743名参与者,中等质量证据)。对照组均值为1.22,代表炎症减少了22%。使用六至七个月后,它使出血部位(即在0至3分的量表上得分为2或3分)的比例降低了0.13(MD -0.13,95%CI -0.17至-0.08,15项研究,1998名参与者,中等质量证据)。对照组均值为0.27,代表出血减少了48%。牙周炎:使用36个月后,没有证据表明三氯生/共聚物牙膏与对照组在牙周炎(附着丧失)的发生方面存在差异(RR 0.92,95%CI 0.67至1.27,1项研究,480名参与者,低质量证据)。龋齿:使用24至36个月后,当使用龋失补牙面(DFS)指数时,三氯生/共聚物牙膏使冠部龋齿略有减少(MD -0.16,95%CI -0.31至-0.02,4项研究,9692名参与者,高质量证据)。对照组均值为3.44,代表冠部龋齿减少了5%。使用36个月后,三氯生/共聚物牙膏可能减少了根面龋齿(MD -0.31,95%CI -0.39至-0.23,1项研究,1357名参与者,中等质量证据)。牙结石:使用六个月后,三氯生/共聚物牙膏可能使每位参与者的平均牙结石总量减少了2.12毫米(MD -2.12毫米,95%CI -3.39至-0.84,2项研究,415名参与者,低质量证据)。对照组均值为14.61毫米,代表牙结石减少了15%。不良反应:没有可用于荟萃分析的关于不良反应的数据,但22项研究(73%)报告试验牙膏或对照牙膏均未引起不良反应。在牙菌斑、牙龈炎和牙结石的荟萃分析中存在相当大的异质性。牙菌斑和牙龈炎显示出如此一致的结果,以至于不影响我们的结论,但读者可能希望更谨慎地解释结果。

作者结论

有中等质量证据表明,与不含三氯生/共聚物的含氟牙膏相比,含三氯生/共聚物的含氟牙膏可减少牙菌斑、牙龈炎症和牙龈出血。这些减少可能具有或不具有临床重要性,无论初始牙菌斑和牙龈炎水平如何,或者是否进行了基线口腔预防,这种减少都是明显的。高质量证据表明,三氯生/共聚物牙膏可使冠部龋齿略有减少。有较弱的证据表明三氯生/共聚物牙膏可能减少了根面龋齿和牙结石,但没有足够的证据表明它们是否预防了牙周炎。在长达三年的研究中,使用三氯生/共聚物牙膏似乎没有任何严重的安全问题。

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