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. 2023 May 8;9(5):389. doi: 10.3390/gels9050389

Table 2.

Summary of clinical trials using scaffolds without cells for bone regeneration from 2018 to 2023.

Cells Scaffolds Condition Number of Patients (Age) Follow Up Control Evaluation Methods and Outcomes References Registration ID and Country
No cells Anorganic bovine bone (BioOss Xenograft) Bilateral Maxillary Sinus Floor Augmentation 8 (>18 years) 6 months Active Comparator (contralateral: biphasic phycogenic biomaterial and autogenous cortical bone) CBCT scans before the sinus floor elevation and 6 months later before implant placement to calculate vertical bone height change from the crestal bone to the floor of the maxillary sinus.
Histomorphometric quantification of new mineralized tissue, non-mineralized tissue and remaing graft particles in a bone biopsy collected 6 months after the grafting procedure.
NO outcomes.
No publication, no results posted.
Actual study completion date 2018
NCT03682315
Responsable: Pablo Galindo-Moreno, Universidad de Granada, Spain
Phase not applicable
No cells Anorganic bovine bone (BioOss Xenograft) + autogenous cortical bone Bilateral Maxillary Sinus Floor Augmentation 10 (>18 years) 6–12–18 months Active Comparator (contralateral:
Porcine bone mineral (Symbios Xenograft) + autogenous cortical bone)
CBCT scans after the sinus floor elevation and 6–12–18 months later before implant placement to calculate vertical bone height change.
Histomorphometric quantification of new mineralized tissue, non-mineralized tissue and remaing graft particles in a bone biopsy collected 6–12–18 months after the grafting procedure.
NO outcomes.
No publication, no results posted.
Actual study completion date 2022
NCT03797963
Responsable: Pablo Galindo-Moreno, Universidad de Granada, Spain
Phas not applicable
No cells but BL®
was mixed with autologous blood previously extracted from
the alveolar defect and applied with a spatula.
DEXGEL Bone: Bonelike by Biosckin® (BL®), a glass-reinforced hydroxyapatite
synthetic bone substitute, in association to dextrin-based hydrogel, DEXGEL
Alveolar ridge preservation 12 (above 18 years) 6 months BL® granules (250–500 μm) were administered to 6 randomized participants whereas the other 6 received DEXGEL Bone. Both treatments showed good osseointegration. DEXGEL Bone exhibited increased granule resorption accompanied by
a tendency for more new bone ingrowth compared to the BL® group. DEXGEL was rapidly resorbed and accelerated
BL® resorption as well, freeing up space that favored
new bone ingrowth, without compromising mechanical
support. The healing of defects was free of any local or systemic complications.
Machado et al., 2023 [42] EUDAMED: CIV-PT-18–01–02,705.
RNEC: 30122.
Portugal
Phase not reported