Simultaneous Sinus Augmentation with Implant Placement: Histomorphometric Comparison of Two Different Grafting Materials. A Multicenter Double-Blind Prospective Randomized Controlled Clinical Trial

Purpose: Sinus elevation via the lateral approach for implant rehabilitation of atrophic posterior maxillae is considered a safe and predictable therapy. Several xenogeneic biomaterials of different biologic origin have been used as valid and predictable alternatives to autogenous bone. This multicenter randomized controlled double-blind prospective clinical trial aimed to compare histomorphometrically two xenogeneic grafting materials used for sinus elevation with simultaneous implant placement. Materials and Methods: Seven private practices in Italy were involved. Patients presenting at least one site with a residual bone crest height between 2 and 4 mm were treated. Control sites were grafted with 100% deproteinated particulated bovine bone (DPBB), while test sites were grafted with prehydrated corticocancellous porcine bone (PCPB). Root-form implants were placed simultaneously. Insertion torque and clinical stability were assessed and recorded. At 6 months, a biopsy specimen was harvested from each site, and histomorphometric analyses were performed. Results: Thirty-seven patients received 42 sinus elevations (24 test and 18 control). Eighty-two implants with adequate primary stability were placed. Fifty-five implants were placed in residual bone crests greater than 2 mm but less than 4 mm (average 2.7 mm) and achieved an average insertion torque of 22.8 +/- 11.3 N/cm. Nineteen implants were placed in ridges greater than 3 mm but less than 5 mm, and eight were placed in ridges with more than 5 mm remaining. After 6 months, three implants had failed to integrate, leading to a survival rate of 96.34%. Forty-two specimens were analyzed histomorphometrically. No significant differences in total bone volume (PCPB 37.43%, DPBB 37.52%) or residual grafting material (PCPB 13.55%, DPBB 16.44%) were detected. Conclusions: In this study, PCPB compared well with DPBB as a grafting material for lateral sinus elevation.