Evaluation of the genotoxic effects of formocresol application in vital pulp therapy of primary teeth: a clinical study and meta-analysis
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This in vivo research investigated whether pulp treatments using formocresol for 7 days would cause mutagenic changes in children’s lymphocytes.
Materials and methods
The mutagenicity was tested in lymphocyte cultures established from the peripheral blood of children living in Brazil. The samples consisted of 2000 cells from teeth undergoing formocresol pulpotomies in which the formocresol pellet was sealed in the primary tooth for 7 days. It was removed on the seventh day, the base was placed, and the tooth was restored. Two venous blood samples (6–8 ml) were collected from each child; the first was prior to pulp therapy, and the second was 7 days later. Two thousand metaphases were analyzed. The level of significance adopted for the statistics was P < 0.05, and a random effects meta-analysis was performed combining this and two previous studies.
There was no significant difference found in the metaphase analysis between the blood samples taken before and after the pulpotomy treatment (Wilcoxon signed rank test); however, the meta-analysis showed a significant difference between the combined studies.
This study did not reveal any mutagenic effects, but based on the combined meta-analysis, we recommend the careful use of formocresol.
This research helps to bring scientific evidence of the safe use of formocresol in deciduous pulpotomy treatments.
KeywordsPulpotomy Formaldehyde Mutagenesis Formocresol Genotoxicity
The authors would like to thank the Brazilian Ministry of Education (Coordination for the Improvement of Higher Education Personnel, CAPES) for their support during the development of this study.
Compliance with ethical standards
Conflict of interest
The authors declare that they have no conflict of interest.
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. The ethical committee of Medical Center Fernando Figueira Institute (IMIP – Brazil – IRB 748/2006) approved the study.
For all participating children, parents and/or guardians provided written informed consent.
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