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Title: Randomized clinical study of injectable dextrin-based hydrogel as a carrier of a synthetic bone substitute
Authors: Machado, Alexandra
Pereira, Isabel
Costa, Filomena
Brandão, Ana
Pereira, José Eduardo
Maurício, Ana Colette
Santos, José Domingos 
Amaro, Inês 
Falacho, Rui I. 
Coelho, Rui 
Cruz, Nuno
Gama, Miguel
Keywords: Synthetic bone; Dextrin; Injectable hydrogel; Alveolar preservation
Issue Date: Mar-2023
Publisher: Springer Nature
Project: Open access funding provided by FCT|FCCN (b-on). The authors were funded by FEDER and NORTE 2020 through project no. 003262 titled “iBONE therapies: advanced solutions for bone regeneration.” This study was supported by the Portuguese Foundation for Science and Technology (FCT) under the scope of the strategic funding of the UID/BIO/04469 unit and COMPETE 2020 (POCI-01–0145- FEDER-006684) and BioTecNorte operation (NORTE-01–0145- FEDER-000004) funded by the European Regional Development Fund under the scope of Norte 2020—Programa Operacional Regional do Norte. The authors were granted a scholarship (SFRH/ BD/132000/2017) by Portuguese FCT. This work was also funded by project UIDB/CVT/00772/2020 supported by FCT. 
Serial title, monograph or event: Clinical Oral Investigations
Volume: 27
Issue: 3
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.
ISSN: 1436-3771
DOI: 10.1007/s00784-023-04868-9
Rights: openAccess
Appears in Collections:FMUC Medicina - Artigos em Revistas Internacionais

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