Table 2.
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 |