Maxillary sinus floor elevation with bovine bone mineral combined with either autogenous bone or autogenous stem cells: a prospective randomized clinical trial

Abstract

To assess whether differences occur in bone formation after maxillary sinus floor elevation surgery with bovine bone mineral (BioOss(®)) mixed with autogenous bone or autogenous stem cells. The primary endpoint was the percentage of new bone three months after the elevation procedure. In a randomized, controlled split-mouth design, in 12 consecutive patients (age 60.8 ± 5.9 years, range 48-69 years) needing reconstruction of their atrophic maxilla, a bilateral sinus floor augmentation procedure was performed. Randomly, on one side the augmentation procedure was performed with bovine bone mineral (BioOss(®)) seeded with mononuclear stem cells harvested from the posterior iliac crest (test group) while BioOss(®) mixed with autogenous bone (harvested from the retromolar area) was applied on the contra-lateral side (control group). On 14.8 ± 0.7 weeks after the sinus floor elevation, biopsies from the reconstructed areas were taken at the spots where subsequently the endosseous implants were placed. The biopsies were histomorphometrically analyzed. Significantly more bone formation was observed in the test group (17.7 ± 7.3%) when compared with the control group (12.0%± 6.6; P=0.026). In both the test and control group, all implants could be placed with primary stability. In one patient, not all biopsies contained BioOss(®). This patient was excluded from analysis. Mesenchymal stem cells seeded on BioOss(®) particles can induce the formation of a sufficient volume of new bone to enable the reliable placement of implants within a time frame comparable with that of applying either solely autogenous bone or a mixture of autogenous bone and BioOss(®). This technique could be an alternative to using autografts.