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

Objectives: 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.
Materials and Methods: First, Biodentine was compared to the composite Z100®, 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 Z100®.
Results: 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 (≤1) without secondary decay and post-operative pain. Biodentine kept acceptable surface properties regarding anatomic form score (≤1), marginal adaptation score (≤2) and interproximal contact score (≤1) for up to 6 months after placement. Resistance to marginal discoloration was superior with Biodentine compared to Z100®. When Biodentine was retained as a dentine substitute after pulp vitality control, it was covered systematically with the composite Z100®. This procedure yielded restorations that were clinically sound and symptom free.
Conclusions: Biodentine is able to restore posterior teeth for up to 6 months. When subsequently covered with Z100®, it is a convenient, efficient and well tolerated dentine substitute.
Clinical Relevance: Biodentine as a dentine substitute can be used under a composite for posterior restorations.