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在乳牙中,没有明确证据表明牙髓药物具有优越性。

No clear evidence of superiority regarding pulp medicaments in primary molars.

作者信息

Elkhadem Ahmed, Sami Inas

机构信息

Evidence Based Dentistry Centre, Egypt.

Department of Dental Biomaterials, Faculty of Oral and Dental Medicine, Cairo University, Egypt.

出版信息

Evid Based Dent. 2014 Dec;15(4):100-1. doi: 10.1038/sj.ebd.6401056.

DOI:10.1038/sj.ebd.6401056
PMID:25522937
Abstract

DATA SOURCES

Cochrane Oral Health Group's Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL), Medline, Embase, the Web of Science, OpenGrey, the US National Institutes of Health Trials Register and the World Health Organization (WHO) Clinical Trials Registry Platform.

STUDY SELECTION

Two reviewers independently selected studies. Randomised controlled trials comparing different pulp interventions combining a pulp treatment technique and a medicament in primary teeth were considered.

DATA EXTRACTION AND SYNTHESIS

Data abstraction and risk of bias assessment were carried out independently by two reviewers. The primary outcomes were clinical failure and radiological failure, as defined in trials, at six, 12 and 24 months. Pairwise meta-analysis using fixed-effect models was conducted with statistical heterogeneity being assessed using I2 coefficients.

RESULTS

Forty-seven trials involving 3910 teeth were included. All were small single centre studies. The overall level of evidence was low with only one trial having a low risk of bias, 20 a high risk and 26 unclear risk of bias.The 47 trials examined 53 different comparisons: 25 for pulpotomy, 13 for pulpectomy, 13 for direct pulp capping and two comparisons between pulpotomy and pulpectomy.Regarding pulpotomy, 14 trials compared mineral trioxide aggregate (MTA) with formocresol (FC). MTA reduced both clinical and radiological failures at six, 12 and 24 months, although the difference was not statistically significant. MTA also showed favourable results for all secondary outcomes measured, although again, differences between MTA and FC were not statistically significant (with the exception of pathological root resorption at 24 months and dentine bridge formation at six months). MTA showed favourable results compared with calcium hydroxide (CH) (two trials) for all outcomes measured, but the differences were not statistically significant (with the exception of radiological failure at 12 months). When comparing MTA with ferric sulphate (FS) (three trials), MTA had statistically significantly fewer clinical, radiological and overall failures at 24 months. This difference was not shown at six or 12 months.FC was compared with CH in seven trials and with FS in seven trials. There was a statistically significant difference in favour of FC for clinical failure at six and 12 months, and radiological failure at six, 12 and 24 months. FC also showed favourable results for all secondary outcomes measured, although differences between FC and CH were not consistently statistically significant across time points. The comparisons between FC and FS showed no statistically significantly difference between the two medicaments for any outcome at any time point.For all other comparisons of medicaments used during pulpotomies, pulpectomies or direct pulp capping, the small numbers of studies and the inconsistency in results limits any interpretation.

CONCLUSIONS

We found no evidence to identify one superior pulpotomy medicament and technique clearly. Two medicaments may be preferable: MTA or FS. The cost of MTA may preclude its clinical use and therefore FS could be used in such situations. Regarding other comparisons for pulpectomies or direct pulp capping, the small numbers of studies undertaking the same comparison limits any interpretation.

摘要

数据来源

考科蓝口腔健康小组试验注册库、考科蓝对照试验中央注册库(CENTRAL)、医学索引数据库(Medline)、荷兰医学文摘数据库(Embase)、科学引文索引数据库(Web of Science)、OpenGrey、美国国立卫生研究院试验注册库以及世界卫生组织(WHO)临床试验注册平台。

研究选择

两名评审员独立选择研究。纳入比较乳牙中不同牙髓干预措施(联合一种牙髓治疗技术和一种药物)的随机对照试验。

数据提取与综合分析

两名评审员独立进行数据提取和偏倚风险评估。主要结局为试验中定义的6个月、12个月和24个月时的临床失败和影像学失败。采用固定效应模型进行成对荟萃分析,并使用I²系数评估统计异质性。

结果

纳入了47项涉及3910颗牙齿的试验。所有试验均为小型单中心研究。总体证据水平较低,仅有1项试验偏倚风险较低,20项试验偏倚风险较高,26项试验偏倚风险不明确。这47项试验检验了53种不同的对比:25种用于牙髓切断术,13种用于牙髓摘除术,13种用于直接盖髓术,以及2种牙髓切断术与牙髓摘除术之间的对比。关于牙髓切断术,14项试验比较了三氧化矿物凝聚体(MTA)与甲醛甲酚(FC)。MTA在6个月、12个月和24个月时均降低了临床和影像学失败率,尽管差异无统计学意义。MTA在所有测量的次要结局方面也显示出良好结果,不过同样,MTA与FC之间的差异无统计学意义(24个月时的病理性牙根吸收和6个月时的牙本质桥形成除外)。与氢氧化钙(CH)相比(两项试验),MTA在所有测量结局方面均显示出良好结果,但差异无统计学意义(12个月时的影像学失败除外)。当将MTA与硫酸铁(FS)比较时(三项试验),MTA在24个月时的临床、影像学和总体失败率在统计学上显著更低。在6个月或12个月时未显示出这种差异。FC在7项试验中与CH比较,在7项试验中与FS比较。在临床失败方面,6个月和12个月时以及影像学失败方面,6个月、12个月和24个月时,FC有统计学显著优势。FC在所有测量的次要结局方面也显示出良好结果,尽管FC与CH之间的差异在各时间点并非始终具有统计学意义。FC与FS之间的比较在任何时间点的任何结局方面均未显示出两种药物之间有统计学显著差异。对于牙髓切断术、牙髓摘除术或直接盖髓术中使用的所有其他药物比较,研究数量少且结果不一致限制了任何解读。

结论

我们没有发现明确识别一种更优牙髓切断术药物和技术的证据。两种药物可能更可取:MTA或FS。MTA的成本可能使其无法用于临床,因此在这种情况下可使用FS。关于牙髓摘除术或直接盖髓术的其他比较,进行相同比较的研究数量少限制了任何解读。

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本文引用的文献

1
Development of a core set of outcomes for randomized controlled trials with multiple outcomes--example of pulp treatments of primary teeth for extensive decay in children.多结局随机对照试验核心结局指标集的制定——以儿童广泛龋坏的乳牙牙髓治疗为例
PLoS One. 2013;8(1):e51908. doi: 10.1371/journal.pone.0051908. Epub 2013 Jan 3.
2
Clinical study of Mineral Trioxide Aggregate in primary molars. Comparison between Grey and White MTA--a long term follow-up (84 months).《矿化三氧化物凝聚体用于乳磨牙的临床研究。灰色和白色 MTA 的对比——长期随访(84 个月)》
J Dent. 2011 Feb;39(2):187-93. doi: 10.1016/j.jdent.2010.11.010. Epub 2010 Dec 7.
3
Pulp treatment for extensive decay in primary teeth.
乳牙大面积龋坏的牙髓治疗。
Cochrane Database Syst Rev. 2003(1):CD003220. doi: 10.1002/14651858.CD003220.