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

Abstract

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.

Figures

Fig. 1

Restoration evaluation during the follow-up phase: anatomic form (a), marginal adaptation (b), quality of proximal contact (c), marginal discoloration (d), and surface roughness (e). Shown is the percentage of patients who were attributed the indicated scores at the follow-up visits D15, M6 and M12. The following scores were statistically significantly different between Biodentine and Z100® restorations: for “anatomic form” at each time point (p = 0.004 on D15, p < 0.001 at M6 and M12); for “marginal adaptation” and “point of proximal contact” at M6 and M12 (p < 0.001). The scores for “marginal discoloration” and “surface roughness” were not significantly different

Fig. 1

Restoration evaluation during the follow-up phase: anatomic form (a), marginal adaptation (b), quality of proximal contact (c), marginal discoloration (d), and surface roughness (e). Shown is the percentage of patients who were attributed the indicated scores at the follow-up visits D15, M6 and M12. The following scores were statistically significantly different between Biodentine and Z100® restorations: for “anatomic form” at each time point (p = 0.004 on D15, p < 0.001 at M6 and M12); for “marginal adaptation” and “point of proximal contact” at M6 and M12 (p < 0.001). The scores for “marginal discoloration” and “surface roughness” were not significantly different

Fig. 2

Occurrence of Z100® complementary treatment on Biodentine cases. Shown is the number of Biodentine cases recovered by Z100® related to the date (expressed in month) when occurred the complementary treatment of Z100®. Black bars represent 1–6 months, grey bars represent 7–12 months and the light grey bars represent after 12 months