Sinus Membrane Elevation with Heterologous Cortical Lamina: A Randomized Study of a New Surgical Technique for Maxillary Sinus Floor Augmentation without Bone Graft

Background: The aim of this randomized controlled clinical trial was to compare the efficacy of two different techniques for maxillary sinus augmentation using a lateral window approach: Heterologous cortical lamina without any grafting material versus 100% collagenated granular collagen porcine bone. Methods: Twenty-three healthy patients with not relevant past medical history (14 women and 9 men, non-smokers, mean age 52 years, range 48–65 years) were included. In Group I, the sinus was filled with collagen porcine bone (Geno-os, OsteoBiol, Turin, Italy) and a collagen membrane (Evolution, OsteoBiol, Turin, Italy) was used to close the lateral window of the sinus. In Group II, the sinus was treated with heterologous cortical lamina only (Lamina, OsteoBiol, Turin, Italy). Results: There was a statistically significant difference in the surgical time required to complete the augmentation procedures: 18.3 ± 2.1 min for lamina treated sites versus 12.5 ± 3.1 min for porcine bone treated sites. In Group I, the mean volume of the graft was 3101 ± 321 mm(3) in the immediate postoperative examination (5–7 days), while after a six-month healing period it was 2716.7 ± 432 mm(3). Conclusion: This study demonstrates that the use of heterologous cortical lamina is a valid technique for the mechanical support of sinus membranes resulting in only bone tissue formation and not mixed with the graft. The graft material was biocompatible and not completely resorbed after six months, although the remains were integrated into the bone.