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.

Bone Regeneration Using Mesenchymal Stromal Cells and Biocompatible Scaffolds: A Concise Review of the Current Clinical Trials

“…Background information from each trial was summarized including clinical phase, condition, controls used, and follow-up. Studies were conducted in Spain [35], Mexico [36], Norway [37], the Czech Republic [38], Italy [39][40][41], Western Australia (NCT01742260), and Spain and Portugal [42]. One trial was reported in three publications [39][40][41].…”

“…One trial was reported in three publications [39][40][41]. Two clinical trials were at Phase I [35] (NCT01742260), two were at Phase I/II [37,39], one was at Phase IIa [38], and phase was not reported in one clinical trial [36,42]. The studies were prospective, open, non-randomized [35,37,[39][40][41], randomized [36,42], interventional (NCT01742260), and in particular, one trial was multicentric [39][40][41].…”

“…Two clinical trials were at Phase I [35] (NCT01742260), two were at Phase I/II [37,39], one was at Phase IIa [38], and phase was not reported in one clinical trial [36,42]. The studies were prospective, open, non-randomized [35,37,[39][40][41], randomized [36,42], interventional (NCT01742260), and in particular, one trial was multicentric [39][40][41]. The most common indications concerned the treatment of lumbar intervertebral degenerative disc disease (DDD) [35], the alveolar ridge [37,42], large skeletal defects [38], and fracture of long bones [29][30][31][32][33][34][35][36][37][38][39][40].…”

“…The studies were prospective, open, non-randomized [35,37,[39][40][41], randomized [36,42], interventional (NCT01742260), and in particular, one trial was multicentric [39][40][41]. The most common indications concerned the treatment of lumbar intervertebral degenerative disc disease (DDD) [35], the alveolar ridge [37,42], large skeletal defects [38], and fracture of long bones [29][30][31][32][33][34][35][36][37][38][39][40]. Clinical evaluation showed that the patients achieved lumbar fusion in up to five years using TCP and autologous MSCs [35].…”

Self-healing hydrogels for bone defect repair

“…The stability of primary implants was analyzed using the implant stability coefficient method; the study finally concluded that the hydrogel reinforcement material was easy to handle and showed good defect healing effect. 208 Currently, only a few clinical trials have examined the application of hydrogels in bone repair, which poses a challenge for future clinical transformation.…”