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

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.

Materials

All reagents used were of the highest degree of purity commercially available, suitable for biopharmaceutical production. Dextrin from Tackidex B 167 (Batch E8747) was kindly provided by Roquette (Lestrem, France), sodium m‐periodate (CAS no. 7790‐28‐5) and diethylene glycol (CAS no. 111‐46‐6) were purchased from BIOCHEM Chemopharma (Cosne sur loire, France). Adipic acid dihydrazide (ADH; CAS no. 1071‐93‐8) was supplied by Merck KGaA (Darmstadt, Germany) and endotoxin free phosphate‐buffered saline (PBS; CAS no. 10049‐21‐5) by BioConcept (Allschwil, Switzerland). BL® was provided by Biosckin, Molecular and Cell Therapies, S.A. (Maia, Portugal).

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Machado, A., Pereira, I., Costa, F. et al. Randomized clinical study of injectable dextrin-based hydrogel as a carrier of a synthetic bone substitute. Clin Oral Invest (2023).
https://doi.org/10.1007/s00784-023-04868-9