Clinical evaluation of the performance and safety of a new dentine substitute, Biodentine, in the restoration of posterior teeth - a prospective study

A multicentric randomized, 3-year prospective study was conducted to determine for how long Biodentine, a new biocompatible dentine substitute, can remain as a posterior restoration. First, Biodentine was compared to the composite Z100A (R), to evaluate whether and for how long it could be used as a posterior restoration according to selected United States Public Health Service (USPHS)' criteria (mean +/- SD). Second, when abrasion occurred, Biodentine was evaluated as a dentine substitute combined with Z100A (R). A total of 397 cases were included. This interim analysis was conducted on 212 cases that were seen for the 1-year recall. On the day of restoration placement, both materials obtained good scores for material handling, anatomic form (0.12 +/- 0.33), marginal adaptation (0.01 +/- 0.10) and interproximal contact (0.11 +/- 0.39). During the follow-up, both materials scored well in surface roughness (a parts per thousand currency sign1) without secondary decay and post-operative pain. Biodentine kept acceptable surface properties regarding anatomic form score (a parts per thousand currency sign1), marginal adaptation score (a parts per thousand currency sign2) and interproximal contact score (a parts per thousand currency sign1) for up to 6 months after placement. Resistance to marginal discoloration was superior with Biodentine compared to Z100A (R). When Biodentine was retained as a dentine substitute after pulp vitality control, it was covered systematically with the composite Z100A (R). This procedure yielded restorations that were clinically sound and symptom free. Biodentine is able to restore posterior teeth for up to 6 months. When subsequently covered with Z100A (R), it is a convenient, efficient and well tolerated dentine substitute.