Biodentine

20
❹ Outstanding
biocompatibility
From a regulatory point of view, Biodentine is a calcium silicate based material, used
for crown and root dentine repair treatment, involving external contact for a period of
more than 30 days. The biocompatibility tests required for the preclinical evaluation of
dental products followed the guideline ISO 7405 - 2008.
The following sections evaluate the compliance with this standard for the tests carried
out on Biodentine. It is considered a device with external contact, for long-term tissue
contact (>30 days). In certain indications (radicular, apical obstruction and repair of the
pulpal floor), it can be considered an implanted system, according to the ISO
classification.
All biocompatibility tests were carried out on the final product Biodentine.
4.1 - Cytotoxicity tests (ISO 7405, ISO 10993-5)
Different cytotoxicity tests carried out on Biodentine are reported.
The first study was performed on human pulpal fibroblasts (human wisdom tooth),
comparing Biodentine, calcium hydroxide and MTA (Dycal ® , Dentsply and ProRoot ®
MTA Dentsply). The cell viability was determined by MTT incorporation (About, 2003b).
Results showed Biodentine was non cytotoxic like MTA, whereas the undiluted cement
Dycal ® induced 22 % of cytotoxicity (Table. 1).
Product Cell death (%)
Biodentine 0±8
MTA 0±9
CaOH 22±10
Table 1. Cell death after Dycal ® , MTA
and BIODENTINE contact.
Control
Biodentine
(4 weeks)
MTA
(4 weeks)
Collagen DSP
Moreover, the cell differentiation was evaluated
with the expression of collagen, dentine
sialoprotein (DSP) and osteonectin (OSN).
Results showed the expression of the
differentiation markers, underlining the safety
of Biodentine (Fig. 8).
Figure 8. Expression of
collagen and dentine
sialoprotein (DSP) after
contact with Biodentine
and MTA during 4 weeks.