Randomized clinical study of injectable dextrin-based hydrogel as a carrier of a synthetic bone substitute.

ABSTRACT

OBJECTIVES: This study aimed to improve the performance and mode of administration of a glass-reinforced hydroxyapatite synthetic bone substitute, Bonelike by Biosckin® (BL®), by association with a dextrin-based hydrogel, DEXGEL, to achieve an injectable and moldable device named DEXGEL Bone. METHODS: Twelve participants requiring pre-molar tooth extraction and implant placement were enrolled in this study. BL® granules (250-500 µm) were administered to 6 randomized participants whereas the other 6 received DEXGEL Bone. After 6 months, a bone biopsy of the grafted area was collected for histological and histomorphometric evaluation, prior to implant placement. The performance of DEXGEL Bone and BL® treatments on alveolar preservation were further analyzed by computed tomography and Hounsfield density analysis. Primary implant stability was analyzed by implant stability coefficient technique. RESULTS: The healing of defects was free of any local or systemic complications. Both treatments showed good osseointegration with no signs of adverse reaction. DEXGEL Bone exhibited increased granule resorption (p = 0.029) accompanied by a tendency for more new bone ingrowth (although not statistically significant) compared to the BL® group. The addition of DEXGEL to BL® granules did not compromise bone volume or density, being even beneficial for implant primary stability (p = 0.017). CONCLUSIONS: The hydrogel-reinforced biomaterial exhibited an easier handling, a better defect filling, and benefits in implant stability. CLINICAL RELEVANCE This study validates DEXGEL Bone safety and performance as an injectable carrier of granular bone substitutes for alveolar ridge preservation. TRIAL REGISTRATION European Databank on Medical Devices (EUDAMED) No. CIV-PT-18-01-02,705; Registo Nacional de Estudos Clínicos, RNEC, No. 30122.