RT Journal Article
T1 Bone Augmentation of Atrophic Alveolar Ridges Using a Synthetic Bone Substitute With Mesenchymal Stem Cells: A Randomized, Controlled Clinical Trial
A1 Sanz Alonso, Mariano
A1 Gjerde, Cecilie
A1 Gjertsen, Bjørn Tore
A1 Ortiz-Vigón, Alberto
A1 Sánchez Pérez, Silvia Nerea
A1 Hoornaert, Alain
A1 Caballe-Serrano, Jordi
A1 Giralt-Hernando, Maria
A1 Gaultier, Frederick
A1 Reinald, Nicoleta
A1 Pinholt, Else Marie
A1 Rojewski, Markus
A1 Rouard, Helen
A1 Chevallier, Nathalie
A1 Mohamed-Ahmed, Samih
A1 Shi, Xieqi
A1 Shi, Tie-Jun
A1 Schrezenmeier, Hubert
A1 Layrolle, Pierre
A1 Mustafa, Kamal
AB Objectives: To assess the efficacy and safety of a cell-based therapy for 3D bone augmentation of severe alveolar bone defects prior to dental implant placement.Materials and methods: A Phase 2 randomized controlled clinical trial evaluated the safety and efficacy of a cell therapy using expanded autologous iliac crest-derived mesenchymal cells seeded on a synthetic bioabsorbable bone substitute covered with a non-resorbable membrane. The control group received an autogenous bone block graft. After 5 months, CBCT scans were compared to measure the bone volume changes achieved after the regenerative surgery. Subsequently, dental implants were placed in the regenerated areas.Results: A total of 48 patients were included and randomized (36 patients in the test group and 12 in the control group). However, seven patients did not reach the minimum required number of expanded MSCs and were therefore unable to be treated. The tested intervention demonstrated significantly greater gains in bone volume, with a mean difference of 480.01 mm3 (p = 0.032). Similarly, the mean change in bone crest volume from baseline to 5 months was notably higher in the test group (1066.91 mm3) compared to the control group (586.9 mm3). Adverse reactions and patient morbidity were minor in both groups. Implants were placed on the regenerated bone, and all were integrated successfully in both groups.Conclusions: The cell-based therapy resulted in significant changes in bone volume compared to the control treatment, enabling dental implants in all patients. The procedure was associated with minimal adverse effects and patient morbidity.
PB Willey
SN 0905-7161
YR 2025
FD 2025-11
LK https://hdl.handle.net/20.500.14352/131159
UL https://hdl.handle.net/20.500.14352/131159
LA eng
NO Sanz M, Gjerde C, Gjertsen BT, Ortiz-Vigón A, Sanchez N, Hoornaert A, Caballe-Serrano J, Giralt-Hernando M, Gaultier F, Reinald N, Pinholt EM, Rojewski M, Rouard H, Chevallier N, Mohamed-Ahmed S, Shi X, Shi TJ, Schrezenmeier H, Layrolle P, Mustafa K. Bone Augmentation of Atrophic Alveolar Ridges Using a Synthetic Bone Substitute With Mesenchymal Stem Cells: A Randomized, Controlled Clinical Trial. Clin Oral Implants Res. 2025 Nov;36(11):1498-1514. doi: 10.1111/clr.70025
DS Docta Complutense
RD 20 mar 2026