Injectable Bone Substitute Material on the Basis of β-TCP and Hyaluronan Achieves Complete Bone Regeneration While Undergoing Nearly Complete Degradation

PURPOSE: In this prospective study, the regenerative potential and pathways of a new injectable bone substitute (IBS) material composed of beta-tricalcium phosphate (β-TCP) and hyaluronan were investigated for its application in alveolar bone regeneration within extraction sockets.

MATERIALS AND METHODS: The bone substitute material was implanted in 44 extraction sockets after removal of teeth not worth preserving in the maxillary and mandibular arches of 21 patients. Four months after augmentation, bone biopsy samples were harvested simultaneously with implant placement for histologic and histomorphometric analysis of tissue reaction and determination of tissue formation (newly formed bone, connective tissue, and remaining IBS) within the augmentation bed. Furthermore, the inserted bone-level implants (C-Tech Esthetic Line) were followed up clinically and radiologically for at least 1 year after prosthetic loading to determine the potential impact of tissue reaction to the IBS on implant stability and performance.

RESULTS: The histologic and histomorphometric analyses revealed a gentle tissue reaction with mainly mononuclear and only few multinucleated giant cells within the implantation bed. Histomorphometric analysis revealed mainly newly formed bone tissue (44.92% ± 5.16%) and connective tissue (52.49% ± 6.43%). Only a few remnants of the IBS (2.59% ± 2.05%) could be found. The IBS, with its easy application and fluidity, seemed to be suitable for three-dimensional stable defects such as the intact extraction socket.

CONCLUSION: The IBS contributed to an osteoconductive tissue reaction while undergoing a time-controlled degradation. Clinical and radiological follow-up investigation of the implants inserted in the regenerated area revealed that the IBS contributed to a long-term stable implantation bed for dental implants. The appearance of the IBS can be described as a bulk that is formed within the augmentation bed and that promotes new bone formation through an osteoconductive procedure.