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

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Abstract

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 I2 and τ2 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.

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Acknowledgements

We are thankful to Professor Venkateshbabu Nagendrababu for reading this paper and for his help in improving this study. Also, we are thankful to Professor Giuseppe Troiano for helping us in using Trial Sequential Analysis software.

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Correspondence to Naser Aslaminabadi.

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Supplementary Information

Below is the link to the electronic supplementary material.

Supplementary file1 Supplementary Figure 1. PRISMA Flo diagram of the literature search (PDF 50 KB)

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Supplementary file2 Supplementary Figure 2. Funnel plots showing publication bias A) clinical success at 6th month B) clinical success at 12th month C) radiographic success at 6th month D) radiographic success at 12th month (PDF 92 KB)

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Supplementary file3 Supplementary Figure 3. L’Abbe plots showing the trend of the meta-analysis A) clinical success at 6th month B) clinical success at 12th month C) radiographic success at 6th month D) radiographic success at 12th month (PDF 88 KB)

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Supplementary file4 Supplementary Figure 4. Influence analysis for clinical success at 6th month to detect outlier studies (PDF 17 KB)

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Supplementary file5 Supplementary Figure 5. Reperformed meta-analysis for clinical success at 6th month after removing outliers (PDF 5 KB)

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Supplementary file6 Supplementary Figure 6. Influence analysis for clinical success at 12th month to detect outlier studies (PDF 16 KB)

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Supplementary file7 Supplementary Figure 7. Reperformed meta-analysis for clinical success at 12th month after removing outliers (PDF 5 KB)

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Supplementary file8 Supplementary Figure 8. Influence analysis for clinical success at 6th month to detect outlier studies (PDF 17 KB)

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Supplementary file9 Supplementary Figure 9. Reperformed meta-analysis for clinical success at 6th month after removing outliers (PDF 5 KB)

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Supplementary file10 Supplementary Figure 10. Influence analysis for clinical success at 12th month to detect outlier studies (PDF 16 KB)

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Supplementary file11 Supplementary Figure 11. Reperformed meta-analysis for clinical success at 12th month after removing outliers (PDF 5 KB)

Supplementary file12 Supplementary Table 1. Applied search strategy and the number of retrieved records (DOCX 13 KB)

Supplementary file13 Supplementary Table 2. GRADE quality of evidence (DOCX 16 KB)

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Firoozi, P., Salman, B.N. & Aslaminabadi, N. Clinical and radiographic comparison of Biodentine and Formocresol: an updated meta-analysis with trial sequential analysis. Eur Arch Paediatr Dent 23, 855–867 (2022). https://doi.org/10.1007/s40368-022-00715-9

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