Introduction: Direct pulp capping treatment is intended to preserve pulp vitality, to avoid or retard root canal treatment, and, in cases with an open apex, to allow continued root development. Historically, calcium hydroxide (CH) was the gold standard material, but nowadays calcium silicate materials (CSMs) are displacing CH because of their high bioactivity, biocompatibility, sealing ability, and mechanical properties. However, more randomized clinical trials are needed to confirm the appropriateness of CSMs as replacement materials for CH in direct pulp capping procedures.
Methods: A randomized clinical trial was conducted that included 169 patients (mean age, 11.3 years) from the Maipo district (Chile). The inclusion criterion was patients with 1 carious permanent tooth with pulpal exposure, a candidate for a direct pulp capping procedure. The patients were randomly allocated to one of the experimental groups (CH, Biodentine, or mineral trioxide aggregate [MTA]). Clinical follow-up examinations were performed at 1 week, 3 months, 6 months, and 1 year. The Fisher exact test was performed.
Results: At the follow-up examination at 1 week, the patients showed 100% clinical success. At 3 months, there was 1 failure in the CH group. At 6 months, there were 4 new failures (1 in the CH group and 3 in the MTA group). At 1 year, there was another failure in the CH group. There were no statistically significant differences among the experimental groups.
Conclusions: CSMs appear to be suitable materials to replace CH. Although no significant differences were found among the materials studied, Biodentine and MTA offered some advantages over CH.
Keywords: Biodentine; calcium hydroxide; direct pulp capping; mineral trioxide aggregate; randomized clinical trial.
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