Clinical and radiographic comparison of Biodentine and Formocresol: an updated meta-analysis with trial sequential analysis

Purpose 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. Methods 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-2 and tau(2) 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. Results 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. Conclusion 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.

Automated summary

This study compared the clinical and radiographic success rates of Biodentine and Formocresol in pulpotomy treatment. The results showed that Biodentine was superior to Formocresol in terms of radiographic success rate. However, there was no significant difference between the two in terms of clinical efficacy.