Firoozi Parsa, Salman Bahareh Nazemi, Aslaminabadi Naser
Student Research Committee, School of Dentistry, Zanjan University of Medical Sciences, Zanjan, Iran.
Department of Pediatric Dentistry, School of Dentistry, Zanjan University of Medical sciences, Zanjan, Iran.
Eur Arch Paediatr Dent. 2022 Dec;23(6):855-867. doi: 10.1007/s40368-022-00715-9. Epub 2022 May 20.
This meta-analysis aimed to compare the clinical and radiographic success rate of Biodentine as an alternative to Formocresol to provide a critical appraisal of the available literature and evidence-based conclusion as well as update the previous systematic review.
MEDLINE, CENTRAL, Web of Science, Scopus, and Google Scholar databases were searched up to 20 October 2021 to identify RCTs evaluating pulpotomy with Biodentine/Formocresol in carious primary molars among children ≤ 10 years old. The risk of bias was assessed using the Cochrane RoB-2 tool. RRs and corresponding 95% CIs were calculated to pool results that RR ˃ 1 indicated a higher success rate in the Biodentine group and RR < 1 indicated a higher success rate in the Formocresol group. Heterogeneity was calculated using the I and τ statistics. In addition, trial sequential analysis was performed to adjust results for type I and type II errors and evaluate power of the meta-analysis.
Nine RCTs were identified and eight RCTs were included in the meta-analysis and trial sequential analysis. The obtained evidence showed no significant difference between Biodentine and Formocresol in terms of clinical efficacy. However, considering the radiographic success rate the results of the meta-analysis and trial sequential analysis significantly favoured Biodentine.
Within the limitations of the present review and based on the retrieved findings it has been clearly shown that Biodentine is superior compared to Formocresol in terms of radiographic success rate with firm evidence in this regard. Although the performed meta-analysis showed no significant clinical difference between Biodentine and Formocresol, however, trial sequential analysis revealed a lack of firm evidence in this regard.
本荟萃分析旨在比较生物陶瓷（Biodentine）作为甲酚甲醛（Formocresol）替代品的临床和影像学成功率，对现有文献进行批判性评价并得出基于证据的结论，同时更新先前的系统评价。
检索截至2021年10月20日的MEDLINE、CENTRAL、科学网、Scopus和谷歌学术数据库，以识别评估10岁及以下儿童龋损乳牙采用生物陶瓷/甲酚甲醛进行牙髓切断术的随机对照试验（RCT）。使用Cochrane RoB - 2工具评估偏倚风险。计算相对危险度（RR）及相应的95%置信区间（CI）以汇总结果，RR＞1表明生物陶瓷组成功率更高，RR＜1表明甲酚甲醛组成功率更高。使用I²和τ统计量计算异质性。此外，进行试验序贯分析以调整I型和II型错误的结果，并评估荟萃分析的效能。
共识别出9项RCT，其中8项RCT纳入荟萃分析和试验序贯分析。获得的证据表明，生物陶瓷和甲酚甲醛在临床疗效方面无显著差异。然而，考虑到影像学成功率，荟萃分析和试验序贯分析的结果显著支持生物陶瓷。
在本综述的局限性内，基于检索结果明确表明，在影像学成功率方面，生物陶瓷优于甲酚甲醛，且在这方面有确凿证据。尽管所进行的荟萃分析显示生物陶瓷和甲酚甲醛在临床方面无显著差异，然而，试验序贯分析表明在这方面缺乏确凿证据。
